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Clinical Trials in Spain / NCT05776927
Recruiting Phase 3

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.

NCT05776927 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2026-08-04
Last updated
2026-09-11

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

QVM149Salmeterol Xinafoate / Fluticasone PropionatePlacebo to QVM149Placebo to salmeterol xinafoate / fluticasone propionate

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

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
Key Inclusion criteria: * Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit * Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening. * Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening * Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening * Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol/180-360 μg albuterol at run-in visit * Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 criteria at both run-in and before randomization Key Exclusion criteria: * Participants who have had a severe asthma attack/exacerbation requiring systemic steroids OR hospitalization (\> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation * Participants who have ever required intubation for a severe asthma attack/exacerbation * Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis * Participants with Type I diabetes or uncontrolled Type II diabetes * Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in * Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months * Participants with a history of long QT syndrome or a family history of a first degree relative with sudden cardiac death under the age of 50 years, or participants whose QTc measured at run-in or at baseline (prior to randomization) (Fridericia method) is prolonged (\> 450 msec for males and \> 460 msec for females) and confirmed by a central assessor or the inability to determine the QT interval corrected by Fridericia's formula (QTcF) interval (these participants should not be re-screened) * Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria * Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
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 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 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 Spain

Other trials for the same condition

Official registry record

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 Spain