Health Condition 1: J45- Asthma
Conditions
Interventions
Intervention1: Vilanterol, Umeclidinium, Fluticasone Furoate: Patients will be dispensed one container of 30 capsules each containing either the test drug or the reference drug depending upon their al
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of either gender between 18-65 years of age (both inclusive) 2. Participants diagnosed with asthma for at least 12 months prior to screening 3. Pre-bronchodilator FEV1 of 40% to 80% of the predicted normal value at screening 4. Participants with bronchodilator reversibility i.e., increase in FEV1 of greater than or equal to 12% and greater than or equal to 200 ml after salbutamol inhalation at screening 5. Participants receiving ICS/LABA combination for asthma for at least 3 months with stable dose of medium or high dose of ICS/LABA combination for greater than or equal to 4 weeks prior to screening 6. Participants who are symptomatic at screening defined as Asthma Control Test (ACT) score less than or equal to 15 7. Participants with a history of at least one severe asthma exacerbation within past 12 months prior to screening 8. Participants willing to provide written informed consent and comply with the protocol requirements 9. Participants literate enough to fill the diary card Asthma exacerbation which required medical care from a physician, emergency room visit or hospitalization and required systemic corticosteroid treatment
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any beta-agonist, sympathomimetic drug, anti-muscarinic agent or any inhaled, intranasal or systemic corticosteroid 2. History of life-threatening asthma within past 5 years prior to screening 3. Asthma exacerbation requiring systemic corticosteroids or that resulted in hospitalization or emergency room visit within 6 weeks prior to screening 4. Patients treated with a long-acting muscarinic antagonist within 3 months prior to screening 5. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 6. Suspected or confirmed bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks prior to screening 7. Patients with concurrent respiratory disorder other than asthma such as but not limited to pneumonia, pulmonary tuberculosis, chronic bronchitis, chronic obstructive pulmonary disease, pneumothorax, atelectasis, bronchopulmonary dysplasia, interstitial lung disease, cystic fibrosis 8. Clinical evidence of oropharyngeal candidiasis at screening 9. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 10. Patients with hepatic dysfunction (serum transaminases greater than or equal to 3 x Upper Normal Limit) or renal dysfunction (serum creatinine greater than or equal to 2.5 mg/dl) at screening 11. Patients who have used prohibited medications 12. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 13. Current smokers or ex-smokers who have stopped smoking within 6 months prior to screening or have a smoking history of at least 10 pack-years 14. Patients with continuing history of alcohol and/or drug abuse 15. Participation in another clinical trial within 3 months prior to screening 16. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Change from baseline in trough FEV1 b. Change from baseline in trough FVC c. Change from baseline in post-bronchodilator FEV1 & FVC d. Change from baseline in the ACT score e. Proportion of rescue medication free days f. Asthma exacerbations reporting g. Global impression of change in the disease condition by the patients Timepoint: a. Week 4 b. Week 12 c. week 4 & at Week 12 d. 4 weeks, 8 weeks & at Week 12 e. 4 weeks, 8 weeks & at Week 12 f. 4 weeks, 8 weeks & at Week 12 g. week 12 | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Ltd
Outcome results
None listed