Salmeterol has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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salmeterol studies

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Study IDPhaseTitle
408DP-02 IV A Multi-Centre Randomized, Double-Blind, Parallel-Group, Comparison of Salmeterol Xinafoate Inhalation Rotadisk Versus Tulobuterol Tape in Subjects with Persistent Adult Asthma Treated with Inhaled Corticosteroid.
408DP-03 IV A Multi-Center, Randomized, Double-Blind, Parallel-Group, Comparison of Salmeterol Xinafoate Inhalation Rotadisk Versus Placebo in Subjects with Chronic Obstructive Pulmonary Disease Treated with Current Medications.
SALMD/AH90/J85 (SLGQ85) IV A phase IV, multi-centre, double-blind, double-dummy, parallel group study to determine whether adult asthmatic patients, currently symptomatic on 400mcg daily inhaled corticosteroid therapy, are better maintained by an increase in corticosteroid dose to 1000mcg daily beclomethasone dipropionate (Becloforte) or by the combined therapy of salmeterol xinafoate (Serevent) 50mcg twice daily plus 400mcg daily inhaled beclomethasone dipropionate (Becotide).
SALMP/AH93/J119 IV A phase IV, multi-centre, double-blind, randomised, parallel group study in general practice to compare the efficacy and tolerability of inhaled salmeterol xinafoate 50 micrograms bd with placebo, both administered via the Diskhaler, in the treatment of episodic asthma induced by upper respiratory tract infection (URTI) in children.
SAM40023 IV A 6 week randomized, double-blind, parallel group study to compare efficacy of fluticasone propionate 250mcg BID, salmeterol 50mcg BID and fluticasone propionate 250mcg plus salmeterol 50 mcg BID for the treatment of nocturnal airway obstruction. Extensive searching has revealed that no clinical report is available for this study. The clinical trial results were reported via publications; see citation below.
SLGA4020 IV A Comparison of Salmeterol Versus Theophylline Versus Salmeterol Plus Theophylline in COPD Patients
SLGA4021 IV A Comparison of Salmeterol Versus Theophylline Versus Salmeterol Plus Theophylline in COPD Patients
SLGA5011 SMART IV SMART: A Double-Blind, Randomized, Placebo-Controlled Surveillance Study of Asthma Event Outcomes in Subjects Receiving Either Usual Pharmacotherapy of Asthma or Usual Pharmacotherapy Plus Salmeterol 42mcg Twice Daily
SLGA5017 IV A comparison of adding SereventŅ versus doubling the dose of BecloventŅ in asthmatic subjects symptomatic on their existing inhaled corticosteroids
SLGA5018 IV A Comparison of Adding Serevent® versus Doubling the Dose of Beclovent® in Asthmatic Subjects Symptomatic on their Existing Inhaled Corticosteroids
SLGA5020 IV A single-center, randomized, double-blind, cross-over clinical trial to examine subsensitivity in adult subjects with asthma receiving salmeterol xinafoate 42mcg BID and placebo BID
SLGA5024 (RM1998/00156/00) IV A randomized, double-blind, parallel group, comparison of inhaled salmeterol xinafoate (42mcg BID) with oral zafirlukast (20mg BID) in subjects with mild to moderate asthma.
SLGA5025 (RM1998/00157/00) IV A randomized, double-blind, parallel group, comparison of inhaled salmeterol xinafoate (42mcg BID) with oral zafirlukast (20mg BID) in subjects with mild to moderate asthma.
SLGB4003 (SLPH01) IV A double-blind randomised, placebo controlled, crossover study to evaluate the duration of protection from exercise induced bronchospasm of inhaled salmeterol xinafoate 50µg (from a Diskhaler) after a single dose and after treatment with 50µg twice daily, for 28 days in children and adolescents with asthma.
SLGB4007 (SMDT09) IV A comparison of salmeterol via Diskhaler with salmeterol via multi-dose powder inhaler in children with exercise-induced asthma.
SLGB4011R IV A phase IV, multi-centre, randomised, double-blind, placebo-controlled, crossover study to assess the effect of salmeterol xinafoate (Severentä) 50 micrograms bd on nocturnal awakenings and sleep dynamics when added to existing therapy in children with nocturnal symptoms of asthma.
SLGB4015 (SLPT16) IV One year treatment with either inhaled corticosteroid or a long acting beta-2-agonist in asthmatic children.
SLGF53 IV A Multi-Centre, Double-Blind, Parallel Group Study to Evaluate the Efficacy of SEREVENT 50mg BID Versus Placebo BID all Administered via the Multi Dose Powder Inhaler (DISKUS/ACCUHALERŌ) in Terms of Symptoms in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
SLGL24 IV A double-blind, randomised, parallel group study to investigate the efficacy of inhaled salmeterol 50µg administered twice daily compared with salbutamol 200µg administered four times daily in patients with poorly controlled nocturnal asthma.
SLGL82 IV A double-blind parallel group study of inhaled salmeterol in asthmatic patients
SLGQ08/SLM8905 IV An eight week randomized, double-blind, parallel group study to compare efficacy of salmeterol 50mcg BID, beclomethasone dipropionate 400mcg BID and salmeterol 50mcg plus beclomethasone dipropionate 400mcg BID in subjects with allergic asthma Extensive searching has revealed that no clinical report is available for this study. The clinical trial results were reported via publication; see citation below.
SLGQ94 (521/180) IV A multicenter, randomized, double-blind, parallel-group trial to evaluate the long-term efficacy and safety of inhaled salmeterol 50?g BID compared to short-acting ?2-agonists as-needed in adult patients with asthma.
SLGQ97 (SLGB4010) IV A multi-centre double-blind, parallel group study to evaluate the relative clinical benefits of three treatment interventions: i) salmeterol xinafoate 50 mcg bd plus fluticasone propionate 250 mcg bd; ii) fluticasone propionate 500 mcg bd; iii) fluticasone propionate 250 mcg bd, in adult asthmatic subjects poorly controlled on current inhaled corticosteroids.
SLGQ98 IV A 12 week randomized, double-blind, parallel group study evaluating effect of fluticasone propionate 500mcg BID, fluticasone propionate 200mcg plus salmeterol 50mcg BID or fluticasone propionate 200mcg BID for control of airway inflammation in subjects with asthma, not controlled on inhaled corticosteroids Extensive searching has revealed that no clinical report is available for this study. The clinical trial results were reported via publication; see citation below.
SLGS04 IV A 12 week randomized, double-blind, parallel group study evaluating effect of salmeterol 50mcg BID or fluticasone propionate 100mcg BID for control of airway inflammation in subjects with asthma, when added to current inhaled corticosteroid therapy Extensive searching has revealed that no clinical report is available for this study. The clinical trial results were reported via publication; see citation below.
SLMF 4002 (SMS40012) IV Efficacy and safety of Salmeterol in patients with asthma controlled with inhaled corticosteroids
SLMF 4010 IV Multicentre, randomised, parallel group, placebo-controlled, double-blind, study, stratified on tobacco status at enrollment, evaluating during 6 months the efficacy of salmeterol powder for inhalation, 50 µg two times per day for the reduction of thoracic distension in subjects with chronic obstructive pulmonary disease (COPD
SLMF4003 IV Contribution of salmeterol in uncontrolled asthma in children
SLMT02 IV Efficacy, Safety and Quality of Life of Inhaled Salmeterol 50mcg BID and Oral Dose Titrated Theophylline Administered 12 Hourly in Patients With Chronic Bronchitis
SMAA0556 (SMS40138) IV Comparison of Salmeterol versus other usually prescribed treatments in adults with moderate to severe asthma.
SMAJ 0145 IV Salmeterol versus other treatments in children with moderate asthma.
SMAJ0234/SMS40124 IV Prophylactic treatment of exercise-induced asthma in children: salmeterol or sodium cromoglycate single dose before exercise
SMS30045 (SLGT26) IV A multicentre, double-blind, parallel group, randomised study comparing the efficacy and safety of inhaled salmeterol xinafoate 50 mg bd and beclomethasone dipropionate 500 mg bd with that of salmeterol xinafoate 100 mg bd and beclomethasone dipropionate 500 mg or beclomethasone dipropionate 1000 mg bd in patients with reversible airways obstruction.
SMS30046 (SLGT 27) IV Effects of long-term administration of salmeterol on clinical symptoms, inhaled corticosteroid requirement and bronchial reactivity, and the effect of stopping long-term salmeterol treatment.
SMS40003 IV A randomized, double-blind, double-dummy, parallel group comparison of salmeterol xinafoate inhalation powder (50mcg BID) with oral montelukast (10mg QD) in subjects with persistent asthma symptomatic on concomitant inhaled corticosteroid therapy.
SMS40004 IV A randomized, double-blind, double-dummy, parallel group comparison of salmeterol xinafoate inhalation powder (50mcg BID) with oral montelukast (10mg QD) in subjects with persistent asthma symptomatic on concomitant inhaled corticosteroid therapy.
SMS40016 IV A double-blind, double dummy, placebo controlled, randomised, cross-over, single dose study comparing the bronchodilator effects of salmeterol 50mcg with a combination bronchodilator Combivent® (ipratropium bromide and salbutamol) in subjects with chronic obstructive pulmonary disease (COPD)
SMS40065 (521/120 [SLPT10]) IV Efficacy and safety of long-term inhaled salmeterol and beclomethasone dipropionate in corticosteroid-naļve children with mild to moderate, chronic, stable asthma.
SMS40221 IV Comparing the efficacy and safety of inhaled salmeterol 50mcg bid and placebo via Diskus in patients with reversible airway obstruction.
SMS40230 IV Randomized, double-blind, parallel-group study of 1 week treatment with salmeterol or placebo added to beclomethasone dipropionate (BDP) on response to allergen challenge Extensive searching has revealed that no clinical report is available for this study. The clinical trial results were reported via publication; see citation below.
SMS40238 (SLGL04) IV Salmeterol MDI (50µg b.d) versus Ketotifen capsules (1mg b.d) in patients with bronchial asthma
SMS40290 (521/040) IV Inhaled salmeterol in adolescents and adult patients with mild to moderate chronic reversible obstructive airways disease. A multicenter, randomized, double-blind, parallel, comparative clinic trial of twelve week courses of 50µg salmeterol administered twice daily, versus 200µg salbutamol administered four times daily.
SMS40298 IV A multi-centre, randomized, double-blind, parallel group study to evaluate the impact on Quality of Life (QOL) of adding Serevent 50ug bid via MDI to patients’ existing therapy in patients with chronic obstructive pulmonary disease (COPD).
SMS40308 IV A randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multicenter study to compare efficacy and tolerability of salmeterol (50 µg b.i.d., Serevent® Diskus®) and a combination of ipratropium/fenoterol (40/100 µg q.i.d., Berodual® MDI) in patients with mild-to-moderate chronic obstructive lung disease (COPD)
SMS40309 IV An multicentre randomised, double-blind, double-dummy, cross-over study to assess the safety and tolerability of salmeterol (50 µg) via DiskusTM and formoterol (12 µg and 24 µg) via TurbohalerTM in co-morbid adults with mild to moderate chronic obstructive pulmonary disease and coronary heart disease
SMS40314 IV A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 8-Week Comparison of Salmeterol Xinafoate Versus Ipratropium Bromide Versus Salmeterol Xinafoate Plus Ipratropium Bromide Versus Placebo in Subjects With Chronic Obstructive Pulmonary Disease
SMS40315 IV A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, 8-Week Comparison of Salmeterol Xinafoate Versus Ipratropium Bromide Versus Salmeterol Xinafoate Plus Ipratropium Bromide Versus Placebo in Subjects With Chronic Obstructive Pulmonary Disease
SMS40318 IV Randomized, double blind, placebo-controlled, parallel-group trial over 4 weeks to evaluate the effect of salmeterol (2x50 µg/d by Diskus®) on the lung volumes at rest and during sub-maximal exercise in subjects with moderate chronic obstructive pulmonary disease (COPD)
SMS40320 IV A Multi-Center, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of Salmeterol Xinafoate Inhalation Aerosol Versus Ipratropium Bromide and Albuterol Sulfate Inhalation Aerosol in Subjects With Chronic Obstructive Pulmonary Disease
SMS40321 IV A Multi-Center, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of Salmeterol Xinafoate Inhalation Aerosol Versus Ipratropium Bromide and Albuterol Sulfate Inhalation Aerosol in Subjects With Chronic Obstructive Pulmonary Disease
SMS40329 IV A Randomised, Single-Blind, Parallel-Group, 28-Day, Pilot Study to Compare the Addition of Inhaled Salmeterol 50µg bid (via the DISKHALER™ Inhaler) or Tulobuterol-Patch 2mg qd Nocte in Adult Asthmatic Subjects who are Symptomatic on Inhaled Corticosteroids Alone
SMS40330 IV A Randomized, Multi-Center, Cross Over Comparison of Salmeterol Xinafoate Inhalation Powder (50mcg BID) via the DISKUS and Salmeterol Xinafoate Inhalation Aerosol (42mcg BID) via the Metered Dose Inhaler on Measures of Device Preference in Subjects with COPD
SMS40332 IV A randomised, open-label, parallel group 28-day pilot study to compare the addition of inhaled salmeterol 50mcg b.i.d. (via the DISKHALER inhaler) or tulobuterol patch 2mg once daily nocte in adult asthmatic subjects symptomatic on treatment with inhaled corticosteroids.
SN408D/04 [e-track No.:102095] IV Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study-
SN408D/05[e-track No.:102094] IV A single-administration, dose response study of Salmeterol xinafoate in paediatric bronchial asthma
Sn408D/06 IV Assessment of efficacy and safety of Serevent? Diskus?plus Flutide (Flixotide)? Diskus? combination therapy for adult bronchial asthma
SNS-D920619 IV Serevent Nationwide Surveillance (SNS) Trial
SALMP/AH91/D89 III A phase III, multi-centre, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate (Serevent™) 50 micrograms BD via the Diskhaler™ when added to the existing treatment of moderate to severe asthmatic children.
SLGA3009 III A 12-month, open-label trial to assess the long-term safety of salmeterol 50 mg bid via the DISKUS in adolescent and adult patients with asthma.
SLGA3010 III A randomized, double-blind, double-dummy, comparative clinical trial of salmeterol 50mcg via the Diskus and salmeterol 50mcg via the metered-dose inhaler versus placebo for 12 weeks in adolescent and adult subjects with mild-to-moderate asthma.
SLGA3011 III A randomized, double-blind, double-dummy, comparative clinical trial of salmeterol 50mcg via the Diskus and salmeterol 50mcg via the metered-dose inhaler versus placebo for twelve weeks in adolescent and adult subjects with mild-to-moderate asthma.
SLGA4004 III A Randomized, Double-blind, Double-Dummy, Comparative Clinical Trial of 12-Week Courses of Salmeterol Xinafoate Versus Ipratropium Bromide Versus Placebo (PRN Ventolin) in Subjects With Chronic Obstructive Pulmonary Disease
SLGA4005 III A Randomized, Double-Blind, Double-Dummy, Comparative Clinical Trial of 12-Week Courses of Salmeterol Xinafoate Versus Ipratropium Bromide Versus Placebo (PRN Ventolin®) in Subjects With Chronic Obstructive Pulmonary Disease
SLGB3019 (SLPT09) III A multicentre, randomised, double-blind, parallel group study comparing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd with that of salbutamol 200mcg to use “as required” from Diskhalers for twelve months in children with asthma.
SLGF55 III Long-Term Treatment of Chronic Obstructive Pulmonary Disease with Salmeterol and the Additive Effect of Ipratropium
SLGH30 III A Study to Determine the Duration of Action of Inhaled Salmeterol During Exercise Challenge Tests in Asthmatic Children
SLGH42 III A Study to Determine the Effects of Chronic Dosing With Inhaled Salmeterol on Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease
SLGL17 III A Single Centre, Randomised, Double-Blind, Cross-Over Study to Compare the Efficacy of Inhaled Salmeterol Xinafoate Dry Powder 50mg BID via the Diskhaler with Placebo Dry Powder BID via the Diskhaler in the Treatment of Non-Reversible COPD Patients and to Provoke with Histamine and Methacholine Before and After Treatment to Investigate Whether Salmeterol Can Reduce the Bronchial Hyperreactivity
SLGS06 (Report No. GRP/95/033) III A Single-Centre, Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study to Compare the Efficacy and Safety of Salmeterol Xinafoate (100mg BID) with that of Placebo BID in Patients with Chronic Obstructive Pulmonary Disease
SLGT01 III A Multi-centre, 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study of 3 Twice-Daily Dosage Schedules of Inhaled GR33343G In Patients With Mild to Moderate Reversible Airways Obstruction
SLGT02 III Inhaled GR33343G In Reversible Airways Obstruction – Efficacy Over 3 Months and Safety Over 12 Months.
SLGT03 III A Double-Blind, Double-Dummy, Randomised, Multi-centre, Cross-over Study to Compare the Relative Efficacy of, and Tolerance to, 50mcg Inhaled GR33343G With Individually Dose-Titrated, Sustained-Release Theophylline (THEODUR®), Administered 12-Hourly, in Patients With Moderate Reversible Airways Obstruction and a Clinical Requirement for Regular Oral Theophylline Therapy
SLGT04 III A Multi-centre, Randomised, Parallel-Group, Double-Blind Study Comparing Inhaled GR33343G 50mcg and 100mcg Twice Daily for 3 Months in Patients With Moderate to Severe Reversible Airways Obstruction
SLGT05 III Assessment of the Comparability of Metered-Dose Inhaler and Dry Powder Formulations of 50mcg GR33343G, Administered Twice Daily for 2 Weeks to Patients with Mild to Moderate Reversible Airways Obstruction.
SLGT06 III Inhaled GR33343G in Reversible Airways Obstruction – Efficacy and Safety Over Three Months: A Double-Blind, Parallel-Group Study Comparing Dry Powder Formulations of Inhaled GR33343G (50mcg) Administered Twice a Day and Inhaled Salbutamol (400mcg) Administered Four Times a Day
SLGT09 III A Study to Assess the Handling of a New Dry Powder Delivery System Containing GR33343G
SLGT28 III A Multicentre, Randomised, Double-Blind, Parallel Group Study to Compare the Efficacy and Safety of Inhaled Salmeterol Xinafoate 50µg bd and Inhaled Salmeterol Xinafoate 100µg bd With Placebo, All Administered via the Metered-Dose Inhaler, in the Treatment of Patients with Chronic Obstructive Pulmonary Disease
SLGT39 III A Multi-Centre, Randomised, Double-Blind, Parallel-Group Study to Compare the Efficacy and Tolerability of Salmeterol (50mg BID) Administered by Pressurised Inhaler Propelled by a Mixture of Propellants 11 and 12 or by an Alternative Propellant, GR106642X in Adult Patients with Reversible Airways Obstruction
SLGT40 III A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Equivalence of Salmeterol 100mg Administered by Pressurised Inhaler Propelled by a Mixture of Propellants 11 and 12 or an Alternative Propellant, GR106642X in the Protection From Methacholine-Induced Bronchoconstriction in Patients with Reversible Airways Obstruction
SLGT41 III A Multi-Centre, Randomised, Double-Blind, Parallel Group Study to Compare the Efficacy and Tolerability of Salmeterol (50mg bd) Administered by Pressurised Inhaler Propelled by a Mixture of Propellants 11 and 12 or by an Alternative Propellant, GR106642X for a Period of One Month in Adult Patients with Reversible Airways Obstruction
SLGT42 III A Multi-National, Multi-Centre, Randomised, Double-Blind, Parallel Group Study to Compare the Efficacy and Tolerability of Salmeterol (50mg bd) Administered by Pressurised Inhaler Propelled by a Mixture of Propellants 11 and 12 or by an Alternative Propellant, GR106642X for a Period of One Month in Adult Patients with Reversible Airways Obstruction
SLGT43 III A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Equivalence of Salmeterol 50mg Administered by Pressurised Inhaler Propelled by a Mixture of Propellants 11 and 12 or an Alternative Propellant, GR106642X in the Protection From Methacholine-Induced Bronchoconstriction in Patients with Reversible Airways Obstruction
SLMP03 III A single centre, randomised, double-blind, parallel group, placebo controlled study, to evaluate the effect of inhaled salmeterol xinafoate (50micrograms bd from a Diskhaler) on variations in bronchoconstriction induced by methacholine, in paediatric patients with mild to moderate asthma.
SLPT01 III A Multicentre, Randomized, Double-Blind, 3-Limbed, Parallel-Group Study Comparing the Efficacy and Tolerability of Salmeterol Xinafoate 25µg and 50µg BID With Salbutamol 200µg BID Given via Pressurized Inhalers in Children With Reversible Airways Obstruction. (3-Month Efficacy and Safety Study.)
SLPT02 III A Multi-centre, Randomised, Double-Blind, 3-Limbed, Parallel-Group Study Comparing the Efficacy and Tolerability of Dry Powder Formulations of Salmeterol Xinafoate 25µg and 50µg Twice Daily With Salbutamol 200µg Twice Daily Given in Children With Reversible Airways Obstruction
SLPT03 III A Multicentre, Randomised, Double-Blind, Parallel-Group Study Comparing Pressurised Inhaler and Dry Powder Formulations of Salmeterol Xinafoate 50µg bd in Children With Reversible Airways Obstruction
SLPT18 III A Multi-Centre, Multi-National, Randomised, Double-Blind, Parallel Group Study to Compare the Efficacy and Tolerability of Salmeterol (50mg BID) Administered by Pressurised Inhaler Propelled by a Mixture of Propellants 11 and 12 or by an Alternative Propellant, GR106642X for a Period of 12 Months in Children with Reversible Airways Obstruction
SMAA0412 / SMS40269 III A Two-Month Comparison of Salmeterol / Beclomethasone and Slow-Release Terbutaline / budesonide in Moderate Asthma Management.
SMAC0190 / SMS40241 III Salmeterol versus slow-release theophylline combined with ketotifen in nocturnal asthma.
SMDT01 III A Double-Blind, Double-Dummy, Randomised Crossover Study to Compare the Effect of a Single 50µg Dose of Salmeterol Administered via the Multidose Powder Inhaler (MDPI) or Diskhaler Dry Powder Inhaler With Placebo in Adult Patients With Reversible Airways Obstruction
SMDT02 III A Multi-Centre, Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to Determine the Clinical Equivalence of Salmeterol Xinafoate 50mg Twice Daily Delivered via a Multi-dose Powder Inhaler (MDPI) or ROTADISK/DISKHALER in Adolescent and Adult Patients With Reversible Airways Disease
SMO30003 III A Single-Centre, Randomised, Placebo-Controlled, Double-Blind, 3-Way Crossover Proof-of-Concept Study to Evaluate the Effect of Reduced Fine Particle Mass (FPM) From the Salmeterol 50mg GR106642X Metered Dose Inhaler Compared With Salmeterol 50mg P11/12 Metered Dose Inhaler on the Peak Bronchodilatory Effect and Bronchoprotection Against Methacholine-Induced Bronchoconstriction
SMO30006 III A Multi-Centre, Randomised, Double-Blind, 12-Week, Parallel-Group Study to Compare Salmeterol Xinafoate 50mcg BD Delivered Either via a HFA Metered-Dose Inhaler or via a CFC Metered-Dose Inhaler, in the Treatment of Adults, Aged 12 years and Over, With Asthma
SMO30007 III A Multi-Centre, Randomised, Double-Blind, 12-Week, Parallel-Group Study to Compare Salmeterol Xinafoate 50mcg bd Delivered Either via a HFA Metered-Dose Inhaler or via a CFC Metered-Dose Inhaler, in the Treatment of Children Aged 4-11 Years With Asthma
SMS30013 (SLPT07) III A multicentre, randomised, double-blind, crossover study to investigate the efficacy and safety of inhaled salmeterol xinafoate (50µg twice daily from the Diskhaler) compared with placebo (from the Diskhaler) with salbutamol (200µg to use ‘as required’ from the Diskhaler) in children with asthma.
SMS30031 (SLGT25) III A phase III, multicentre, randomised, double-blind, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate 100µg bd via the Diskhaler versus inhaled salbutamol 400µg qds via the Diskhaler in the treatment of patients with moderate to severe asthma.
SMS30032 (SLGT17) III Comparison of the efficacy, safety and quality of life benefits of inhaled salmeterol (50mcg bd from a Diskhaler) with that of sodium cromoglycate (20mg qds dry powder).
SMS30035 (SLGT13) III A double-blind, three-way crossover study comparing GR33343G (Salmeterol) 25µg bd, salmeterol 50µg bd and placebo in the treatment of childhood asthma.
SMS30044 (SLGT18) III A multicentre, randomised, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of salmeterol 50 mg bd administered as a metered-dose inhaler and oral encapsulated ketotifen 1 mg bd in patients with mild to moderate reversible airways obstruction.
SMS30049 (SLGT16) III A multicentre, double-blind, double-dummy, parallel group, randomised study comparing the efficacy and safety of inhaled salmeterol 50 mg (DISKHALER) administered 12 hourly and oral dose titrated sustained release theophylline administered 12 hourly in patients with reversible airways obstruction.
SMS30059 (SLGT08). III A double-blind, crossover study comparing the efficacy of 50µg inhaled salmeterol administered twice daily (bd) with 100µg inhaled salmeterol administered once daily at night (nocte) and placebo in subjects with poorly controlled nocturnal asthma.
SMS30076 III A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Clinical Trial of 4 Weeks Treatment With SEREVENT Inhalation Aerosol, 25mcg BID, 50mcg BID, and Placebo Administered via a Valved Holding Chamber With Facemask in Subjects With Asthma Aged 24 to 47 Months
SMS30077 III A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-Center Clinical Trial of Four Weeks Treatment with SEREVENT™ Inhalation Aerosol, 25mcg BID, 50mcg BID and Placebo Administered Via a Valved-Holding Chamber with Facemask in Subjects with Symptoms of Asthma or Reactive Airways Disease Age 6 to 23 months
SMS30078 III Multicentre, randomised, double-blind, cross-over trial to evaluate the tolerance of Salmeterol protective effect in the asthma of effort.
SMS40026 III A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Effect of 12 Months Treatment With Salmeterol (50mcg bd), Delivered via the DISKUS* Inhaler, on the Incidence of Moderate and Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) When Added to Their Usual Treatment Regimen
SMS40081/SLM9009 III A multi-centre, double-blind, randomised, parallel group study comparing the addition of inhaled salmeterol with an increase in the dose of inhaled fluticasone propionate in asthmatic patients on a low or intermediate dose of inhaled steroid.
SMS40093 (SLPT01) III A multi-centre, randomised, double blind, three limbed, parallel-group study comparing the efficacy and tolerability of salmeterol xinafoate 25µg and 50µg bd with salbutamol 200µg bd given via pressurised inhalers in children with reversible airways obstruction. (Results of the final nine months safety phase.)
SMS40097 III Long-term treatment of chronic obstructive pulmonary disease with Salmeterol and the additive effect of Ipratropium.
SMS40099 (SLGT28) III A multicentre, randomised, double-blind, parallel group study to compare the efficacy and safety of inhaled salmeterol xinafoate 50 mg bd and inhaled salmeterol xinafoate 100 mg bd with placebo, all administered via the metered-dose inhaler, in the treatment of patients with chronic obstructive pulmonary disease.
SMS40180/SLM9021B III A 12 week study to compare the efficacy and safety of salmeterol xinafoate plus beclomethasone dipropionate with a double dose of beclomethasone dipropionate in patients with mild to moderate reversible airways obstruction treated by a general practitioner.
SMS40289 (521/020) III Inhaled salmeterol in patients with mild to moderate reversible obstructive airways obstruction. A multicentre, randomized, double-blind, placebo-controlled, cross-over comparison of 50µg salmeterol administered twice daily and 200µg salbutamol administered four times daily.
AC2106956 II A multi-centre, randomised, partially blinded, placebo-controlled, three-way crossover, incomplete block design study to investigate the safety, tolerability, pharmacodynamics/ efficacy and pharmacokinetics of dual bronchodilator therapy with salmeterol 50 mg twice-daily plus two different doses of a new chemical entity (NCE), compared with placebo, salmeterol 50 mg twice-daily alone, and a marketed bronchodilator once-daily alone, in subjects with chronic obstructive pulmonary disease.
B2A10002 II A multi-centre, randomised, double-blind, placebo controlled, crossover study to examine the efficacy, safety, tolerability and systemic pharmacokinetics of single inhaled dose of a new chemical entity in asthmatic subjects.
B2C106093 II Multi-center, randomized, double-blind, placebo-controlled, four-way incomplete block crossover study to examine efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat administration of a novel long-acting beta2-agonist
B2C108562 II A multi-centre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of a NCE (2 dosage strengths, administered once-daily in the morning via DISKUS™ dry-powder inhaler) compared with salmeterol (50mcg administered twice-daily via DISKUS dry-powder inhaler) and placebo in subjects with moderate COPD
B2E106359 II Multi-center, randomized, double-blind, placebo-controlled, four-way incomplete block crossover study to examine efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat administration of a novel long-acting beta2-agonist
SCO20001 II A Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Cardiovascular Pharmacodynamic Effects and Pharmacokinetics of Salmeterol vs Placebo Following 15 Days BD Regimen In COPD Subjects
SLG-102 II A Double-Blind Evaluation of Efficacy, Safety, and Tolerability of Several Single Doses of Salmeterol Hydroxynaphthaote (GR33343G) Compared With Albuterol and Placebo in Asthmatic Patients
SLGA2002 (formerly SMD-202) II A randomized, double-blind, double-dummy, single-dose, three-way cross-over comparison of salmeterol xinafoate 50mcg and placebo given by the multi-dose powder inhaler and Diskhaler for the prevention of exercise-induced bronchospasm in adolescent and adult patients with asthma.
SLGA2004 II A randomized, double-blind, double-dummy, placebo-controlled, comparative clinical trial of salmeterol xinafoate via multi-dose powder inhaler versus salmeterol xinofoate via Diskhaler for four weeks in adolescent and adult subjects with mild-to-moderate asthma.
SLGA2014 II A randomized, double-blind, double-dummy, single-dose, four-way cross-over comparison of salmeterol 25mcg and 50mcg given by the multi-dose powder inhaler (DISKUSTM), albuterol 180mcg given by the metered-dose inhaler, and placebo for the prevention of exercise-induced bronchospasm in pediatric subjects with asthma.
SLGA2015 II A Randomized, Double-Blind, Double-Dummy, Five-Way Crossover Clinical Trial of Single Doses of Salmeterol 25, 50, and 100mcg Via Diskus (Multidose Powder Inhaler), Salmeterol 50mcg Via Metered-Dose Inhaler and Placebo in Adolescent and Adult Subjects With Moderate Asthma.
SLGH01 II The Determination of the Dose-Response Characteristics of Single Inhaled Doses (50mcg, 100mcg, and 200mcg) of GR33343G in Patients With Reversible Airways Obstruction
SLGH03 II The Determination of the Relative Potency of Inhaled GR33343G Metered-Dose Inhaler and GR33343G Dry Powder: A Cumulative Dose-Response Study in Patients With Reversible Airways Disease
SLGH04 II The Determination of the Dose-Response Characteristics of Single Inhaled Doses (12.5mcg, 25mcg, 50mcg, and 100mcg) of GR33343G in Patients With Asthma. A Randomised, Double-Blind Comparison With Inhaled Salbutamol.
SLGH05 II The Determination of the Dose-Response Characteristics of Single Inhaled Doses of GR33343G (12.5mcg, 25mcg, 50mcg, and 100mcg) Administered as a Dry Powder. A Comparison With Salbutamol (200mcg) Administered From a Metered-Dose Inhaler.
SLGH06 II A Single-Centre, Double-Blind, Within-Patient Study to Determine the Dose-Response Characteristics of GR33343G (12.5mcg-100mcg) Given by Metered-Dose Inhaler in Patients With Asthma. A Comparison With Salbutamol (200mcg) Given by Metered-Dose Inhaler.
SLGH07 II To Determine the Dose-Response Characteristics of Inhaled Dry Powder GR33343G 12.5mcg, 25mcg, 50mcg, and 100mcg in Patients With Asthma: A Comparison With Inhaled Salbutamol 200mcg
SLGH08 II A Single-Centre, Single-Dose, Double-Blind, Cross-Over Study to Compare the Bronchodilator Effects of 50mcg GR33343G Metered-Dose Inhaler and 50mcg GR33343G Dry Powder in Asthmatic Patients
SLGH10 II A Double-Blind Cross-Over Study to Determine if 50mcg Inhaled GR33343G (salmeterol) Twice Daily Compared With Salbutamol for 13 Days Caused Tachyphylaxis in Patients With Stable Asthma
SLGH11 II A Single-Centre, Randomised, Double-Blind, Cross-Over Study to Compare the Efficacy of Metered-Dose Inhaler and Dry Powder Formulations of GR33343G With That of Salbutamol Inhaler and Placebo in Patients With Asthma
SLGH12 II A Single-Dose, Double-Blind, Cross-Over Study to Determine the Efficacy and Duration of Action of Inhaled GR33343G 50mcg, as Metered-Dose Inhaler or Dry Powder, Against Histamine-Induced Bronchoconstriction
SLGH13 II To Compare the Effects of Salmeterol and Salbutamol on Speed of Recovery From Methacholine-Induced Bronchoconstriction in Patients With Reversible Airways Disease
SLGH14 II To Determine the Duration of Action of Inhaled GR33343G (salmeterol) (50mcg and 100mcg) Against Methacholine-Induced Bronchoconstriction in Patients With Mild to Moderate Reversible Airways Obstruction
SLGH15 II A Single-Dose, Double-Blind, Placebo-Controlled, Randomised, Cross-Over Study to Determine the Effect of Salmeterol (50mcg via Metered-Dose Inhaler) on Immediate- and Late-Phase Allergen-Induced Bronchoconstriction and Bronchial Hyper-Responsiveness
SLGH17 II A Single-Centre, Double-Blind, Randomised, Cross-Over Study to Determine the Duration of Action of Salmeterol Administered From a Metered-Dose Inhaler Against Exercise-Induced Bronchospasm in Patients With Asthma
SLGH18 II A Cumulative Dosing, Double-Blind, Double-Dummy, Cross-Over Study to Compare the Efficacy of 175mcg GR33343G Administered by 4-Place Diskhaler With 175mcg GR33343G Administered by 8-Place Diskhaler in Asthmatic Patients
SLGS05 II Dose Response to Inhaled Salmeterol in Chronic Obstructive Pulmonary Disease
SLGT11 II Determination of the Efficacy of GR33343G (50mcg Twice Daily) Administered From a Metered-Dose Inhaler in the Elderly.
SLGT12 II Determination of the Efficacy of GR33343G (50mcg Twice Daily) Administered From a Metered Dose Inhaler in the Elderly.
SLGT13 II A Double-blind, Three-Way Crossover Study Comparing GR33343G 25mcg BID, 50mcg BID, and Placebo in the Treatment of Childhood Asthma.
SLM8901 II A Single-Dose, Double-Blind, Placebo-Controlled Cross-over Study to Determine the Efficacy and Duration of Action of Inhaled Salmeterol Xinafoate 50mcg Against Methacholine-Induced Bronchoconstriction in Children with Reversible Airways Obstruction
SMS20010 II A Five-Week, Randomized, Double-Blind, Double-Dummy, Two-Period, Four-Treatment Crossover, Placebo-Controlled, Balanced Incomplete Block Design, Multi-Center Study of Salmeterol Xinafoate Inhalation Aerosol, 25mcg BID, 25 mcg TID, 50mcg BID and Placebo Administered via a Holding Chamber with Facemask in Subjects with Asthma Aged 24 to 47 Months.
SMS20011 II A Five-Week, Randomized, Double-Blind, Double-Dummy, Two-Period, Four-Treatment Crossover, Placebo-Controlled, Balanced, Incomplete Block Design, Multi-Center Study of Salmeterol Inhalation Aerosol 25mcg BID, 25mcg TID, 50mcg BID and Placebo Administered via a Holding Chamber with Facemask in Subjects with Asthma Aged 6 to 23 Months
ACH100539 I A double-blind, randomised, placebo-controlled, double-dummy, four-way cross-over study to evaluate the bronchodilatory effect of single doses of tiotropium bromide [18 mg administered via dry-powder inhaler (DPI)] and salmeterol (50 or 100 mg via DPI) in patients with bronchodilator responsive COPD.
ACH101824 I A single-centre, randomised, double blind, placebo-controlled, double-dummy, dose escalating cross-over study to examine the safety, tolerability, systemic pharmacokinetic profile and pharmacodynamics of single inhaled doses of a new chemical entity and salmeterol (50 µg via DPI) in COPD patients.
B2A10001 I A randomised, double blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetic profile of single inhaled doses of a new chemical entity in healthy male subjects.
B2B10001 I A randomised, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, systemic pharmacokinetic profile and pharmacodynamics of single inhaled doses of a new chemical entity in healthy male subjects.
B2B10002 I A multi-centre, randomised, double-blind, double dummy, placebo-controlled, 5-period crossover study to examine the safety, tolerability, systemic pharmacodynamics, and systemic pharmacokinetics of single inhaled doses of a new chemical entity in asthmatic subjects
B2C101762 I A multi-centre, randomised, double-blind, placebo-controlled, dose-ascending, four way crossover study to examine efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat doses of a new chemical entity (NCE).
B2F100819 I A randomised, double-blind, three-way crossover study to investigate the effects of nebulised sterile water for injection on beta-agonist induced bronchodilation in healthy male and female volunteers
B2F104300 I A randomised, double blind, placebo controlled study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled dry powder doses of a novel long acting ß-2-receptor agonist in healthy male subjects and asthmatics
C93-097 I A study to determine the dose equivalence for systemic effects for salmeterol compared with salbutamol given by MDI in healthy subjects.
GPK:89:06 I To Investigate the Pharmacokinetics of Hydroxynaphthoic Acid in Healthy Volunteers
GPK:89:08 I Comparison of the Single-Dose Pharmacokinetics of Hydroxynaphthoic Acid in Subjects with Renal Failure and in Healthy Subjects
GSK159797/001. I A multi-centre, randomised, double-blind, placebo controlled, crossover study to examine the efficacy, safety, tolerability and systemic pharmacokinetics profile of single inhaled dose of a new chemical entity, salmeterol and placebo in asthmatic subjects.
RES10988 I A randomised, double-blind, triple-dummy, placebo-controlled, five-way cross-over study to investigate the bronchodilatory effects of single doses of salmeterol (25, 50 and 200 mg) and salbutamol (200 mg) over a 24-h period in healthy subjects.
RES11070 I A randomised, double-blind, triple-dummy, placebo-controlled, five-way crossover study to investigate the bronchoprotective effects against methacholine challenge and the bronchodilatory effects of single doses of salmeterol (25, 50 and 200 µg) and salbutamol (200 µg) over a 24-hour period in atopic non-asthmatic subjects.
SLGB10006 I A Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Compare the Systemic Pharmacodynamic Effects and Pharmacokinetics of Salmeterol Delivered by the Non-CFC Propellant (HFA-134a; GR106642X) and the CFC Propellant (Propellant 11/12) Metered Dose Inhalers in Healthy Subjects
SLGB1002 I A study to investigate to what extent the swallowed fraction of an inhaled dose of salmeterol contributes to its systemic effects
SLGB1005 I A study to investigate the potential interaction between terfenadine, erythromycin and salmeterol.
SMS106128 I A double-blind, randomised, two-period, crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects of 7 days co-administration of salmeterol (50 mcg bid) with ketoconazole (400 mg od).
WHP:88:03 I To Investigate the Effect of Regular Treatment With Salmeterol on the Cardiovascular, Tremorogenic, Metabolic, and Respiratory Effects of Inhaled Salbutamol (Study No. WHP:88:03)
WHP:88:13 I Metabolic Studies on Salmeterol Hydroxynaphthoate. The Absorption, Metabolism and Excretion of 14C-Salmeterol in Man After Oral Administration of 14C-Salmeterol Hydroxynaphthoate (1mg Base)
WHP:88:15 I The Effect of Regular Treatment with Salmeterol on the Cardiovascular System, 12-Lead ECG, Skeletal Muscle Tremor and Lung Function
WHP:89:21 I An Investigation Into the Effect of Regular Dosing With Inhaled Salmeterol on the Non-Pulmonary Effects of a Cumulative Dose of Salmeterol. Protocol Number (WHP:89:21).
WMH/84/013 I The effect of oral GR33343X in five healthy subjects.