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Bioequivalence of Generic Fluticasone/Salmeterol vs Advair Diskus in Asthma
NCT03756883Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2018
- Primary completion
- Oct 2019
- Countries
- 1
- Sponsor
- Allergan
- Modality
- Orthosteric Ligands
- Conditions
- asthma
01
Overview
Phase 3, randomised, double-blind trial of fluticasone propionate nasal spray and salmeterol in asthma (3 arms), sponsored by Allergan. Primary endpoints: Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours and Baseline-adjusted Pre-dose FEV1 at Day 29. Started Dec 2018; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Test (Generic F/S)
Fluticasone/Salmeterol 100/50 mcg
Reference (Advair)
Advair Diskus 100/50 mcg
Placebo
Placebo inhalation powder
03
Who it enrols
Patients aged 12-75 with a diagnosis of asthma for at least 12 weeks, pre-bronchodilator FEV1 40-85% predicted, and >=15% reversibility. Smokers and patients with other significant respiratory or systemic diseases are excluded.
04
Endpoints
Primary
Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours
Baseline-adjusted Pre-dose FEV1
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