Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QVM149 · 3 trials · 1 indication
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate | EXPERIMENTAL | * 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 QVM149 | EXPERIMENTAL | * 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 μg | EXPERIMENTAL | QVM149 150/50/80 μg o.d. delivered via Concept1 |
| QVM149 150/50/160 μg | EXPERIMENTAL | QVM149 150/50/160 μg o.d. delivered via Concept1 |
| Salmeterol/fluticasone 50/500 μg plus tiotropium 5 μg | ACTIVE_COMPARATOR | Salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat® |
| QVM149 | EXPERIMENTAL | All eligible patients take QVM149 150/50/160 μg once daily over 52 weeks. |
| Name | Type | Description |
|---|---|---|
| QVM149 | DRUG | QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler® |
| Salmeterol Xinafoate / Fluticasone Propionate | DRUG | Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler® |
| Placebo to QVM149 | DRUG | Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler® |
| Placebo to salmeterol xinafoate / fluticasone propionate | DRUG | Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler® |
| Salmeterol/fluticasone plus tiotropium | DRUG | Free triple arm of salmeterol / fluticasone plus tiotropium |
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...