🏛️ Verified NIH Record • Updated 2026-08-18

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma (NCT05562466)

Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate / Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma. * The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks. * The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.

Who can join: Review the eligibility criteria below.

Location: Novartis Investigative Site — CABA, Buenos Aires

Age range: 6 Years to 11 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (64 Sites)

Showing the first 25 of 64 sites.

  • Novartis Investigative Site — CABA, Buenos Aires
  • Novartis Investigative Site — CABA, Buenos Aires
  • Novartis Investigative Site — CABA, Buenos Aires
  • Novartis Investigative Site — Mendoza, Mendoza Province
  • Novartis Investigative Site — Rosario, Santa Fe Province
  • Novartis Investigative Site — Rosario, Santa Fe Province
  • Novartis Investigative Site — Graz,
  • Novartis Investigative Site — Salzburg,
  • Novartis Investigative Site — Sankt Pölten,
  • Novartis Investigative Site — Porto Alegre, Rio Grande do Sul
  • Novartis Investigative Site — Sorocaba, São Paulo
  • Novartis Investigative Site — Rousse,
  • Novartis Investigative Site — Sevlievo,
  • Novartis Investigative Site — Bucaramanga, Santander Department
  • Novartis Investigative Site — Ibague, Tolima Department
  • Novartis Investigative Site — Cali, Valle del Cauca Department
  • Novartis Investigative Site — Plzen Bory,
  • Novartis Investigative Site — Prague,
  • Novartis Investigative Site — Athens,
  • Novartis Investigative Site — Chaïdári,
  • Novartis Investigative Site — Heraklion Crete.,
  • Novartis Investigative Site — Pátrai,
  • Novartis Investigative Site — Thessaloniki,
  • Novartis Investigative Site — Guatemala City, GTM
  • Novartis Investigative Site — Guatemala City,

📞 Contact the Study Coordinator

Phone: +41613241111

Email: novartis.email@novartis.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Asthma clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗