Health Condition 1: J454- Moderate persistent asthma Health Condition 2: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: FDC of Indacaterol 150 mcg + Glycopyrronium 50 mcg + Mometasone Furoate IP 160 mcg powder for inhalation: powder for inhalation, one capsule once daily.
Control Intervention1: Not Appli
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients Greater than 18 years of age with a diagnosis of asthma, GINA 2024 for a period of at least 1 year prior to Screening. 2. Patients not adequately controlled with a maintenance combination of long acting beta 2 agonist and a high dose of an inhaled corticosteroid. [High dose of ICS: Beclomethasone greater than 400mcg, Budesonide greater than 800mcg, fluticasone furoate greater than 200mcg, fluticasone propionate greater than 500mcg, mometasone furoate greater than 400mcg]. Patient should be on high dose of ICS for at least one month prior to screening. 3. ACQ-5 score greater than or equal to 1.5 at screening. 4. History of one or more asthma exacerbations in last one year. 5. Patients with pre-bronchodilator FEV1 less than 80% of the predicted normal value at screening. 6. An increase in FEV1 of greater than or equal to 12% and 200 mL within 15 to 30 minutes after administration of 400 mcg salbutamol or 200mcg of levosalbutamol.
Exclusion criteria
Exclusion criteria: 1. Patients with acute exacerbation of asthma (acute condition) within past 3 months. 2. Patients who smoked or inhaled tobacco products within 6 months prior to screening or who had a smoking history of greater than 10 pack-years. 3. Received treatment with Triple therapy i.e. ICS/LABA/LAMA within past 6 months. 4. Patients with history of uncontrolled diabetes and/or uncontrolled glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention. 5. Patients with a history of myocardial infarction (confirmed clinically by the investigator) within the previous 12 months. 6. Patients with a documented history of chronic lung diseases other than asthma, 7. Patients who have had a respiratory tract infection or asthma worsening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events including Serious adverse events (SAEs) and Treatment emergent adverse events (TEAE).Timepoint: Baseline Week 6 week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in trough FEV1 at week 6 & week 12 from baselineTimepoint: Week 6 week 12;Mean change in pre-dose morning & evening PEFR at week 6 & 12 from baselineTimepoint: week 6 week 12;Mean change in ACQ-5 score at week 6 & 12 from baseline.Timepoint: Week 6 week 12;Proportion of patients with uncontrolled, partly controlled & well controlled asthma as per ACQ-5 at week 6 & week 12Timepoint: Week 6 week 12;Proportion of patients achieving a minimal clinically important difference (MCID) of a 0.5 units reduction in ACQ-5 from baseline at week 6 & week 12.Timepoint: Week 6 week 12;Percentage of days without rescue medication usageTimepoint: Week 12;Mean change in Mini AQLQ at week 12 from baseline.Timepoint: Week 12;Proportion of patients achieving a MCID of 0.5 units increase in Mini AQLQ from baseline at week 6 & week 12.Timepoint: Week 6 week 12 | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Limited
Outcome results
None listed