Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Indacaterol 150 mcg and Mometasone Furoate 80 mcg/160mcg/320mcg powder for inhalation: Dose: Indacaterol 150 mcg and Mometasone Furoate 80 mcg/160mcg/320mcg powder for inhalation.
Freq
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged =12 years with documented diagnosis of asthma 2. Pre-bronchodilator FEV1 of 40-90% predicted normal 3. Symptomatic patients receiving ongoing treatment with either ICS-SABA or ICS-LABA or SMART 4. ACQ-5 score = 1.5 at baseline. 5. Patient/parent/legal guardian willing to give a written informed consent/parental consent/assent form. 6. Able to/Willing to strictly adhere to investigator’s prescription
Exclusion criteria
Exclusion criteria: 1. History of current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition). 2. Smoking history of more than 10 pack-years 3. Women of childbearing potential are not restricted in this study, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment. 4. Patients who have participated in any clinical trial within 30 days prior to enrolment and would not be participating in clinical study during the period of study participation. 5. History of known hypersensitivity to any individual study drug of the study drug combination or to any of the excipient present in the dosage form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Ind/MF DPI in treatment of patients with asthma in India in terms of - 1.Number of patients with any drug related treatment emergent adverse events (TEAEs). 2.Number of patients with TEAEs 3.Number of patients with serious TEAEs (STEAEs)Timepoint: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of Ind/MF DPI in treatment of patients with asthma in India in terms of- 1. Mean change in Trough FEV1 from baseline 2. Mean change in ACQ-5 score from baseline 3. Percentage change in ACQ-5 score at week 4 and 12 from baseline 4. Number of patients with exacerbations (mild/moderate/severe) 5. Rescue medication use averaged over week 12 of treatment 6. Compliance with the study medication 7. Assessment of patients satisfaction with the treatment 8. Assessment of physicians satisfaction with the treatmentTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed