A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
Condition(s) studied
Investigational drug(s) / intervention(s)
QVM149: QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone Propionate: Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
Placebo to QVM149: Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
Placebo to salmeterol xinafoate / fluticasone propionate: Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
Study summary
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.
Eligibility
Primary outcome measure(s)
- Change from Baseline in Trough FEV1 — Baseline, Week 12 of each treatment period.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Strasbourg | France | Recruiting |
| Novartis Investigative Site | Szeged | Hungary | Recruiting |
| Novartis Investigative Site | Tarnów | Poland | Recruiting |
| Novartis Investigative Site | Bialystok | Poland | Recruiting |
| Novartis Investigative Site | Krakow | Poland | Recruiting |
| Novartis Investigative Site | Lublin | Poland | Recruiting |
| Novartis Investigative Site | Piaseczno | Poland | Recruiting |
| Novartis Investigative Site | Torun | Poland | Recruiting |
| Novartis Investigative Site | Bucharest | Romania | Recruiting |
| Novartis Investigative Site | Bratislava | Mestska Cast Ruzinov | Recruiting |
| Novartis Investigative Site | Košice | Slovakia | Recruiting |
| Novartis Investigative Site | East London | Eastern Cape | Recruiting |
| Novartis Investigative Site | Germiston | Gauteng | Recruiting |
| Novartis Investigative Site | Krugersdorp | Gauteng | Recruiting |
| Novartis Investigative Site | Lenasia | Gauteng | Recruiting |
| Novartis Investigative Site | Paarl | Western Cape | Recruiting |
| Novartis Investigative Site | Cape Town | South Africa | Recruiting |
| Novartis Investigative Site | Santiago Compostela | A Coruna | Recruiting |
| Novartis Investigative Site | Sabadell | Barcelona | Recruiting |
| Novartis Investigative Site | Seville | Spain | Recruiting |
| Novartis Investigative Site | Kaohsiung City | Taiwan | Recruiting |
More Novartis Pharmaceuticals trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05776927 on ClinicalTrials.gov ↗ ← All trials in Poland