Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QVM149 150/50/80 μg o.d · 2 trials · 1 indication
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. 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 primary endpoint considered the following 2 comparison groups: * QVM149 150/50/80 μg o.d. compared with QMF149 150/160 μg o.d. both delivered via Concept1 * QVM149 150/50/160 μg o.d. compared with QMF149 150/320 μg o.d. both delivered via Concept1.
The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma
| Arm | Type | Description |
|---|---|---|
| QVM149 150/50/160 µg o.d. | EXPERIMENTAL | QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device |
| QVM149 150/50/80 µg o.d. | EXPERIMENTAL | QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device |
| QMF149 150/320 µg o.d. | ACTIVE_COMPARATOR | QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device |
| QMF149 150/160 µg o.d. | ACTIVE_COMPARATOR | QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device |
| Salmeterol/fluticasone 50/500 μg b.i.d. | ACTIVE_COMPARATOR | Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler® |
| Sequence 1 | ACTIVE_COMPARATOR | A-B-C |
| Sequence 2 | ACTIVE_COMPARATOR | A-C-B |
| Sequence 3 | ACTIVE_COMPARATOR | B-C-A |
| Sequence 4 | ACTIVE_COMPARATOR | B-A-C |
| Sequence 5 | ACTIVE_COMPARATOR | C-A-B |
| Sequence 6 | ACTIVE_COMPARATOR | C-B-A |
| Name | Type | Description |
|---|---|---|
| QVM149 150/50/160 | DRUG | - |
| QVM149 150/50/80 | DRUG | - |
| QMF149 150/320 | DRUG | - |
| QMF149 150/160 | DRUG | - |
| salmeterol/fluticasone | DRUG | - |
| QVM149 150/50/80 μg o.d. | DRUG | A |
| QVM149 150/50/160 μg o.d. | DRUG | B |
| salmeterol/fluticasone FDC 50/500 μg b.i.d. | DRUG | C |
Inclusion Criteria: * Patients with a diagnosis of asthma, (GINA 2015) for a period of at least 1 year prior to Visit 1 (Screening). * Patients who have used medium or high dose of ICS/LABA combinations for asthma for at least 3 months and at stable medium or high doses of ICS/LABA for at least 1 m...
QVM149 150/50/80 μg o.d is an investigational small molecule being developed for the treatment of asthma. It is a fixed-dose combination product administered once daily. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
QVM149 150/50/80 μg o.d is a combination product containing three active components: a long-acting muscarinic antagonist, a long-acting beta-agonist, and an inhaled corticosteroid. It targets muscarinic receptors, beta-2 adrenergic receptors, and glucocorticoid receptors to provide bronchodilation and anti-inflammatory effects in asthma.
QVM149 150/50/80 μg o.d is developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the efficacy and safety of this investigational asthma treatment.
QVM149 150/50/80 μg o.d is in Phase 3 clinical development for asthma. It is an investigational drug and has not received FDA approval. The Phase 3 program includes a large study comparing QVM149 with another Novartis product, QMF149, in patients with asthma.
QVM149 150/50/80 μg o.d has completed two clinical trials. The Phase 3 study NCT02571777 enrolled 3,092 patients with asthma across multiple countries, comparing QVM149 with QMF149. The Phase 2 study NCT03063086 enrolled 116 patients, assessing bronchodilator effect and safety compared to salmeterol/fluticasone.
QVM149 150/50/80 μg o.d is not the same as QMF149. QVM149 is a triple combination therapy containing a long-acting muscarinic antagonist, a long-acting beta-agonist, and an inhaled corticosteroid. QMF149 is a dual combination of a long-acting beta-agonist and an inhaled corticosteroid. They are being compared in a Phase 3 trial.