Health Condition 1: J45- Asthma
Conditions
Interventions
Intervention1: Vilanterol and Fluticasone furoate metered dose inhalation (12.5/50 mcg & 12.5/100 mcg): Patients will dispensed 2 MDIs each
one for the morning dose and another for the evening dose during visit 2 (Day 0 / Randomization visit) and visit 4 (Week 8).
Patients will be instructed to administer 2 actuations at a time through o
one for the morning dose and another for the evening dose during visit 2 (Day 0 / Randomization visit) and visit 4 (Week 8). Patients will be instructed to administer 2 actuations at a time through or
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 6 months prior to screening 3. Patients receiving low to mid dose ICS-LABA with stable doses for � 4 weeks prior to screening 4. Pre-bronchodilator FEV1 of 40% to 80% of the predicted normal value at screening 5. Patients with bronchodilator reversibility i.e., increase in FEV1 of � 12% and � 200 ml after salbutamol inhalation at screening 6. Patients with Asthma Control Test (ACT) score � 15 at screening 7. Patients willing to provide written informed consent and comply with the protocol requirements 8. Patients literate enough to fill the diary card
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any �²2-agonist, sympathomimetic drug, 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 within 6 months prior to screening 4. Patients diagnosed with COVID-19 within 3 months prior to screening 5. Suspected or confirmed bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks prior to screening 6. 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 7. Clinical evidence of oropharyngeal candidiasis at screening 8. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 9. Patients with hepatic dysfunction (serum transaminases â�¥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine â�¥ 2.5 mg/dl) at screening 10. Patients who have used prohibited medications 11. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 12. 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 13. Patients with continuing history of alcohol and/or drug abuse 14. Participation in another clinical trial within 3 months prior to screening 15. 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 studyTimepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events / Serious adverse events reported during the studyTimepoint: Week 4, Week 8 and Week 12;Asthma exacerbations reported during the studyTimepoint: Week 4, Week 8 and Week 12;Change from baseline in the ACT score at the end of studyTimepoint: Week 12;Change from baseline in trough FEV1 at week 4Timepoint: Week 4;Change from baseline in trough FVC at week 4 and at the end of studyTimepoint: Week 4 and Week 12;Global assessment of efficacy by the investigator at the end of studyTimepoint: Week 12;Global impression of change in the disease condition by the patients at the end of studyTimepoint: Week 12;Overall tolerability evaluation at the end of studyTimepoint: Week 12;Proportion of rescue medication free days during the treatment periodTimepoint: Week 4, Week 8 and Week 12 | — |
Countries
India
Contacts
Public ContactDr Pavankumar M Daultani
Zydus Healthcare Limited
Outcome results
None listed