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A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma
The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 739 |
| Start date | 2012-07 |
| Completion | 2013-07 |
Conditions
- Asthma
Interventions
- Mometasone furoate
- Concept 1
- Twisthaler
Primary outcomes
- Trough Forced Expiratory Volume in 1 Second (FEV1) — Day 29
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.
Countries
Belgium, Canada, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Malaysia, Netherlands, Poland, Russia, Slovakia, Thailand, Turkey (Türkiye), Ukraine