At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 999 enrolled
Drug / intervention
Fluticasone Propionate and Salmeterol Inhalation Powder +2 moredrug
Likely dose
Fluticasone propionate/salmeterol 100/50 mcg per actuationAI-extracted
Key inclusion· 7
- ✓Age 12–75 years
- ✓Asthma diagnosis ≥12 weeks before screening per NAEPP guidelines
- ✓Pre-bronchodilator FEV1 40–85% predicted at screening and randomization
- ✓Airway reversibility ≥15% FEV1 increase within 30 minutes of albuterol 360 mcg
Key exclusion· 10
- ✕Life-threatening asthma (intubation, respiratory arrest, hypoxic seizures, syncope, or hospitalization within 1 year before screening)
- ✕Allergy or hypersensitivity to sympathomimetics, corticosteroids, or milk proteins
- ✕Comorbid respiratory diseases (CF, bronchiectasis, COPD, chronic bronchitis, emphysema, TB, pulmonary carcinoma, fibrosis, hypertension)
- ✕Upper or lower respiratory tract infection, sinusitis, or otitis media within 4 weeks before screening or during run-in
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multiple-Dose, Blinded, Placebo-Controlled, Parallel-Design, Multiple-Center, Clinical Study to Evaluate the Therapeutic Equivalence of Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg to ADVAIR DISKUS® 100/50 (Fluticasone Propionate/Salmeterol) Inhalation Powder, in Subjects With Asthma
In Brief
A Phase 3 clinical trial evaluating Fluticasone Propionate and Salmeterol Inhalation Powder and Placebo Inhalation Powder for Asthma. Completed, enrolled 999 participants across 1 site.
Detailed Summary
A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center bioequivalence study with pharmacodynamic endpoints
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsTeva Pharmaceuticals USA
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartDec 2018
Primary CompletionOct 2019
Study CompletionNov 2019
TodayJul 2026
First PostedNov 28, 2018
Enrollment StartDec 3, 2018
Primary CompletionOct 26, 2019
Study CompletionNov 10, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.6 years ago
Interventions
Fluticasone Propionate and Salmeterol Inhalation Powderdrug
100/50 mcg per actuation
Fluticasone Propionate and Salmeterol Inhalation Powderdrug
100/50 mcg per actuation
Placebo Inhalation Powderdrug
No active content