Health Condition 1: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: Vilanterol 25 mcg + Fluticasone Furoate 200 mcg Dry Powder Inhaler: Dose- Once daily inhalation (In Capsule)
Duration: 24 Weeks
Control Intervention1: Formoterol 6 mcg + Budesonide 40
Sponsors
Glenmark Pharmaceuticals Ltd.
Clinical Research Network India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged greater than or equal to 12 years with documented diagnosis of asthma and uncontrolled on low dose of For/Bud (200 g BD MART). 2. Pre-bronchodilator FEV1 of 40-90% predicted normal. 3. ACQ-5 score greater than or equal to 1.5 at baseline. 4. Patient or parent guardian willing to give a written informed consent/parental consent or assent form. 5. Able to or Willing to strictly adhere to investigator s prescription
Exclusion criteria
Exclusion criteria: 1. Current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition). 2. Patients who have used medium dose Formoterol/Budesonide (6/400 g DPI) (MART) in the past. 3. Patients already on high dose For/Bud (greater than 800 g) 4. Patients with COPD 5. 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. 6. 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 7. 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 compare improvement in asthma control over 24 weeks as assessed by change from baseline in Asthma Control Questionnaire (ACQ-5) score in patients receiving once-daily Vilanterol / Fluticasone DPI vs twice-daily Formoterol/ Budesonide DPI.Timepoint: over 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy endpoints a. To compare changes in lung function parameters FEV1 b. To compare FEV1 c. Proportion of patients with asthma exacerbations during the treatment period d. Proportion of patients requiring hospitalization or exacerbation related medical visits e. Rescue medication use averaged f. To assess Reliever Free days over treatment g. To assess Asthma Control Day over treatment defined as day and night with no asthma symptoms no reliever medication use and no nighttime awakening due to asthma h. To assess nighttime awakenings i. To assess treatment compliance j. Assessment of patient satisfaction with the treatment k. Assessment of physician satisfaction with the treatment Timepoint: From baseline to 24 weeks FEV1 2 hours post dose at baseline Over 24 weeks of treatment;Secondary Safety Endpoints a. Number of patients with any drug related treatment emergent adverse events. b. Number of patients with TEAE c. Number of patients with serious TEAEs.Timepoint: up to Week 24;Exploratory Endpoints a. Proportion of patients achieving clinical remissionTimepoint: At Week 24 | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Glenmark Pharmaceuticals ltd.
Outcome results
None listed