Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QMF149 · 3 trials · 2 indications
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
A TEAE is any adverse event that started on or after the time of the first inhalation of study drug but not later than 7 days (30 days in the case of a SAE) after the last administration. A SAE is described as any adverse event that leads to death, is life-threatening, results in persistent or significant disability/incapacity, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event which is medically significant.
Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.
| Arm | Type | Description |
|---|---|---|
| QMF149 | EXPERIMENTAL | QMF149 75/40μg |
| Budesonide | ACTIVE_COMPARATOR | Budesonide 200μg o.d |
| Salmeterol xinafoate/fluticasone propionate | ACTIVE_COMPARATOR | Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler® |
| Name | Type | Description |
|---|---|---|
| QMF149 | DRUG | QMF149 75/40 μg o.d via Breezhaler |
| Budesonide | DRUG | Budesonide 200 μg o.d via Breezhaler |
| Salmeterol | DRUG | delivered via Accuhaler® |
Inclusion Criteria 1. Male or female children ≥ 6 years and \<12 years in age at randomization. 2. Parents/legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing th...
QMF149 is an investigational small molecule being developed by Novartis AG for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It is a combination of indacaterol acetate and mometasone furoate, delivered via inhalation. The drug is currently in Phase 3 clinical development for these respiratory conditions.
QMF149 targets the beta-2 adrenergic receptor through its component indacaterol acetate, a long-acting bronchodilator, and the glucocorticoid receptor through mometasone furoate, an inhaled corticosteroid. This dual mechanism aims to provide both bronchodilation and anti-inflammatory effects in patients with asthma and COPD.
QMF149 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in respiratory diseases.
QMF149 is currently in Phase 3 clinical development. It has completed a Phase 2 trial in COPD and a Phase 3 long-term safety study in Japanese patients with asthma. A Phase 3 trial in children with asthma is currently recruiting participants. The drug is investigational and not yet approved by regulatory authorities.
QMF149 has been studied in several clinical trials. NCT01636076 was a completed Phase 2 trial in COPD with 629 participants. NCT03100500 was a completed Phase 3 safety study in Japanese asthma patients. NCT05562466 is an ongoing Phase 3 trial evaluating the drug versus budesonide in children aged 6 to less than 12 years with asthma.
Yes, QMF149 is the same as indacaterol acetate/mometasone furoate. The drug combines these two active ingredients in a single inhaler. This combination is being investigated for its potential to improve lung function and control symptoms in patients with asthma and COPD.