Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Vilanterol 12.5 mcg, Glycopyrronium 25
mcg and Fluticasone furoate 100 mcg MDI: The MDI will contain
the test drug, Vilanterol 12.5 mcg, Glycopyrronium 25 mcg and Fluticasone furoate 10
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender between 18-65 years of age (both inclusive) 2. Patients 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. Patients with bronchodilator reversibility i.e., increase in FEV1 of >= 12% and >= 200 ml after salbutamol inhalation at screening 5. Patients receiving ICS-LABA combination for asthma for at least 3 months with stable dose of medium or high dose of ICS-LABA combination for >= 4 weeks prior to screening 6. Patients who are symptomatic at screening defined as Asthma Control Test (ACT) score 7. Patients with a history of at least one severe asthma exacerbation within past 12 months prior to screening 8. Patients willing to provide written informed consent and comply with the protocol requirements 9 Patients literate enough to fill the diary card
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any β2-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. Patients diagnosed with COVID-19 within 3 months prior to screening 7. Suspected or confirmed bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks prior to screening 8. 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 9. Clinical evidence of oropharyngeal candidiasis at screening 10. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 11. Patients with hepatic dysfunction (serum transaminases >= 3 x Upper Normal Limit) or renal dysfunction (serum creatinine >= 2.5 mg/dl) at screening 12. Patients who have used prohibited medications 13. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effectivecontraception 14. 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 15. Patients with continuing history of alcohol and/or drug abuse 16. Participation in another clinical trial within 3 months prior to screening 17. 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 FEV1 at the end of the studyTimepoint: Baseline to end of study (12 Weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1Timepoint: Baseline to Week 4;Change from baseline in trough FVCTimepoint: At week 4 and End of study;Change from baseline in post-bronchodilator FEV1 and FVCTimepoint: At week 4 and End of study;Change from baseline in the ACT scoreTimepoint: At week 4, Week 8 and End of study;Proportion of rescue medication free daysTimepoint: During the Study period;Asthma exacerbations reportedTimepoint: During the study period;Global impression of change in the disease condition by the patientsTimepoint: At the end of study period;Safety endpoinrt- Adverse events and serious adverse events reportedTimepoint: During the study period;Overall tolerability evaluationTimepoint: At the end of study period | — |
Countries
India
Contacts
Public ContactDr Hardik Pathak
Zydus Research Centre
Outcome results
None listed