| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05776927 | 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. | PHASE3 | NOT YET_RECRUITING | 304 | — | — | May 29, 2026 | Dec 24, 2029 | Feb 3, 2026 | - | — |
| NCT03158311 | Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium | PHASE3 | COMPLETED | 1,426 | — | — | Feb 5, 2018 | Jul 19, 2019 | Oct 8, 2021 | 163 | Argentina, Chile +18 |
| NCT03100825 | A Long-term Safety Study of QVM149 in Japanese Patients With Asthma | PHASE3 | COMPLETED | 96 | — | — | Apr 28, 2017 | Apr 8, 2019 | Apr 7, 2020 | 25 | Japan |
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 |
|---|---|---|
| QVM149 | EXPERIMENTAL | QVM149 (Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg ) od delivered via Breezhaler® and Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler® |
| Salmeterol Xinafoate / Fluticasone Propionate Arm | ACTIVE_COMPARATOR | Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler® and Placebo to QVM149 (Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg ) od delivered via Breezhaler®. |
| 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® |
| Name | Type | Description |
|---|---|---|
| QVM149 | DRUG | QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg od delivered via Breezhaler® |
| Salmeterol Xinafoate / Fluticasone Propionate | DRUG | Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler® |
| Placebo to QVM149 | DRUG | Placebo to QVM149: 150 μg Indacaterol Acetate / 50 μg Glycopyrronium Bromide / 160 μg Mometasone Furoate od delivered via Breezhaler® |
| Placebo to Salmeterol Xinafoate / Fluticasone Propionate | DRUG | Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler® |
| Run-In Medication | DRUG | Salmeterol Xinafoate 50 μg / Fluticasone Propionate 250μg bid delivered via Girohaler® or equivalent DPI device |
| Rescue Medication | DRUG | Salbutamol 100μg / Albuterol 90μg |
| Concept 1 Device | DEVICE | Concept1 (Breezhaler) used for QVM149 and placebo delivery |
| Girohaler | DEVICE | Girohaler for Comparator and Placebo delivery. |
| Salmeterol/fluticasone plus tiotropium | DRUG | Free triple arm of salmeterol / fluticasone plus tiotropium |
Inclusion criteria Participants eligible for inclusion in this study must meet all of the following criteria: 1. Male and female adolescent subjects aged from equal to or greater than 12 years old to less than 18 years old at Screening visit. 2. Written and signed informed consent by parent(s)/leg...