Asthma
Conditions
Interventions
Trade Name: Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS
Product Name: Fluticasone propionate/salmeterol
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: FLUTICASONE PR
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female (non-pregnant, non-lactating, and using acceptable method of birth control) subjects >_12 years old with a documented diagnosis of persistend asthma for at least 6 months were eligible. Subjects were required to be using a low-to-medium dose of an ICS or a combination of controller medications containing a low (total daily) dose of an ICS or combination of controller medications containing a low (total daily) dose ICS for at least 4 weeks preceding Screening. Subjects had to have a pre- albuterol/ salbutamol FEV1 of >_50% and >_85% of predicated normal value at Screening (Visit 1) after withholding asthma controller medication and albuterol/salbutamol >_6 hours and demonstrate an increase in FEV1 of >_12% over the pre-albuterol / salbutamol FEV1 within 30 minutes after the inhalation of 2-4 puffs of albuterol/salbutamol. In addition, each subject must have experienced asthma symptoms requiring albuterol/salbutamol use within 4 weeks preceding Screening. Are the trial subjects under 18? yes Number of subjects for this age range: 147 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 756 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: Subjects could not have life-threatening asthma or worsening asthma which involved an ER visit, hospitalization, or use of oral/ parenteral corticosteroids within 4 weeks of Screening. Subjects could not have current respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], pulmonary fibrosis, pneumonia, etc) or any clinically significant, co-morbid or uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation. Subjects could also not be using any prohibited concurrent medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to demonstrate that FSC DISKUS 250/50 BID is superior to FP DISKUS 250 BID at increasing pulmonary function as measured by forced expiratory volume in one second (FEV1) over a 52-week treatment period.;Secondary Objective: Compare the efficacy of the two treatment groups with respect to the following parameters: morning peak expiratory flow (AM PEF), percent of symptom-free days, and the rate of asthma attacks using a non-validated composite measure. ;Primary end point(s): Comparison of improvement in lung function as measured by FEV1 between ADVAIR DISKUS 250/50 mcg BID vs FLOVENT DISKUS mcg BID over 52 weeks ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Morning peak flow (AM PEF) Percentage of symptom-free days Asthma attack rate •Morning peak flow; percentage of symptom free days; asthma attack rate ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed