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A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients
This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | 2008-01 |
| Completion | 2008-04 |
Conditions
- Asthma
Interventions
- indacaterol maleate / mometasone furoate
- placebo to indacaterol maleate/mometasone furoate
Primary outcomes
- Participants With Adverse Events — 15 days
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention. A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Countries
France