Asthma
Conditions
Interventions
Product Name: Fluticasone propionate/salmeterol
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: FLUTICASONE PROPIONATE
CAS Number: 80474-14-2
Other descriptive name: FLUTIC
Sponsors
GlaxoSmithKiline Research and Development LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of persistent asthma as define by the American Thoracic Society for at least 3 months prior to Visit 1. Use of a short-acting beta-agonist medication like VENTOLIN. Are the trial subjects under 18? yes Number of subjects for this age range: 329 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1819 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63
Exclusion criteria
Exclusion criteria: Hospitalization for asthma 6 months before study Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to evaluate lung function as assessed by AM PEF AUC relative to baseline [AUC(bl)] in subjects who have the B16 Arg/Arg genotype compared with that of subjects who have the B16 Gly/Gly genotype over 16 weeks of treatment with FSC DISKUS 100/50mcg BID.;Secondary Objective: Evaluate lung function by testing morning peak expiratory flow in patients with a Arg/Gly genotype compared to patients with a Arg/Arg or a Gly/Gly genotype over 16 weeks of treatment with ADVAIR and/or SEREVENT ;Primary end point(s): The primary measure of efficacy was area under the curve describing AM PEF relative to baseline [AUC(bl)] over the 16 week double-blind treatment period. The primary comparison of interest was between the Arg/Arg and Gly/Gly genotypes in the FSC treatment group.;Timepoint(s) of evaluation of this end point: 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary measures of efficacy included area under the curve describing PM PEF relative to baseline [AUC(bl)] and pre-dose FEV1. Other secondary measures were change from baseline in percent of symptom free days, and supplemental ipratropium bromide use.;Timepoint(s) of evaluation of this end point: Percent of days symptom free. | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed