Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: QMF149 Twisthaler® (Indacaterol maleate 500 µg/mometasone furoate 400 µg): Once daily via multi-dose dry-powder inhaler throughout the study
Control Intervention1: Mometasone Twisthaler
, 400 µ
g QD: Once daily via multi-dose dry-powder inhaler
Sponsors
Novartis HealthCare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a documented diagnosis of persistent asthma (according to GINA guidelines) for a period of at least 6 months prior to Visit 1 and who are currently treated with or qualify for treatment (according to asthma treatment guidelines) with both ICS and LABA combination. They must have used ICS as part of their asthma regimen for at least 2 months prior to Visit 1. Patients demonstrating an increase in FEV1 of ≥12% or ≥200 mLs within 30 minutes after administration of β2-agonist (SABA) as per site protocol. Alternatively, patients may have documentation of reversibility within the last 12 months. Patients with an FEV1 ≥50% of predicted normal at Visit 2. This criterion for FEV1 will have to be demonstrated after all restricted medications have been withheld for appropriate intervals (washout period of at least 6 hours for a short acting β2-agonist and a minimum of 24 hours for a long acting β2-agonist).
Exclusion criteria
Exclusion criteria: Patients with a previous diagnosis of COPD Patients who have had an asthma attack/exacerbation requiring hospitalization within 1 month prior to visit 3. Patients who have had an emergency room visit asthma attack/exacerbation within 1 month prior to visit 3. 4. Patients who have ever required ventilator support for respiratory failure secondary to asthma 5. Patients with diabetes Type I or uncontrolled (in the judgement of the investigator) diabetes Type II 6. Patients with concomitant pulmonary disease 7. Patients with certain cardiovascular co-morbid conditions 7. Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of serious asthma exacerbationsTimepoint: Time Frame: Event driven study, when pre-defined number of primary outcome events occur or by 21 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of asthma exacerbations that require systemic corticosteroidTimepoint: Time Frame: Event driven study, when pre-defined number of primary outcome events occur or by 21 months;2. Forced expiratory volume in 1 second (FEV1)Timepoint: Time Frame: At Weeks 4, 12, 26, 52, 68 and 84;3. Peak expiratory flow (PEF)Timepoint: Time Frame: Over 21 months;4. Asthma symptom scoreTimepoint: Time Frame: Over 21 months;5. Asthma control as measured by the Asthma Control Questionnaire (ACQ)Timepoint: Time Frame: Over 21 months | — |
Countries
Brazil, Colombia, Czech Republic, Hungary, India, Peru, Republic of Korea, Slovakia, United States of America
Contacts
Public ContactMurugananthan K
Outcome results
None listed