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QVM149

Phase 3

Asthma | Small molecule | Respiratory |Novartis AG|Last Updated: Jul 27, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment1,826
FDA Designations
No designations recorded
Clinical trial landscape

QVM149 · 3 trials · 1 indication

Phase 3 3
NCT05776927A 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.Asthma
NOT YET_RECRUITING188 Analytics
NCT03158311Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + TiotropiumAsthma
COMPLETED1,426 Analytics
NCT03100825A Long-term Safety Study of QVM149 in Japanese Patients With AsthmaAsthma
COMPLETED96 Analytics
PHASE3NOT YET_RECRUITING
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.
AsthmaUnlock trial analytics
PHASE3COMPLETED
Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium
AsthmaUnlock trial analytics
PHASE3COMPLETED
A Long-term Safety Study of QVM149 in Japanese Patients With Asthma
AsthmaUnlock trial analytics
Study Endpoints
Primary Endpoints
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.

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score
Baseline and Week 24

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale, where 1=totally limited/problems all the time and 7= not at all limited/no problems. It consists of 4 domains: symptoms, activity limitation, emotional funtion, and emotional stimuli. The overall score is calculated as the mean of 32 items. Higher AQLQ scores indicate better health-related quality of life.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Up to 52 Weeks

An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as adverse events started on or after the time of the first inhalation of study drug but no later than 7 days after the last administration (30 days in the case of SAEs). SAE was defined as any adverse event (appearance of \[or worsening of any pre-existing\]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.

Secondary Endpoints
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score
Baseline, Week 12 of each treatment period
Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score
Baseline, Week 12 of each treatment period
Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)
Baseline, Week 12 of each treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionateEXPERIMENTAL* QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1. * Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2.
Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149EXPERIMENTAL* Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1. * Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2.
QVM149 150/50/80 μgEXPERIMENTALQVM149 150/50/80 μg o.d. delivered via Concept1
QVM149 150/50/160 μgEXPERIMENTALQVM149 150/50/160 μg o.d. delivered via Concept1
Salmeterol/fluticasone 50/500 μg plus tiotropium 5 μgACTIVE_COMPARATORSalmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®
QVM149EXPERIMENTALAll eligible patients take QVM149 150/50/160 μg once daily over 52 weeks.
Interventions
NameTypeDescription
QVM149DRUGQVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone PropionateDRUGSalmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
Placebo to QVM149DRUGPlacebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
Placebo to salmeterol xinafoate / fluticasone propionateDRUGPlacebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
Salmeterol/fluticasone plus tiotropiumDRUGFree triple arm of salmeterol / fluticasone plus tiotropium
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Eligibility Criteria
Age Range12 Years to 17 Years
SexALL
Healthy VolunteersNo

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 scre...

Countries:ArgentinaChileColombiaCzechiaGermanyGreeceHungaryIndiaIsraelMexicoPeruPolandRussiaSerbiaSlovakiaSouth AfricaSpainTaiwanTurkey (Türkiye)VietnamJapan
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Recent Changes (Last 90 Days)
HIGHJul 27, 2026NCT05776927Enrollment: 304 → 188
LOWMay 26, 2026NCT05776927primaryCompletionDate: changed
LOWMay 24, 2026NCT05776927studyFirstPostDate: changed