Health Condition 1: J454- Moderate persistent asthma Health Condition 2: J453- Mild persistent asthma
Conditions
Interventions
Intervention1: Formoflo DPI 250: Inhale one Transcap twice daily (morning and evening) using the Lupihaler device for 24 weeks
Intervention2: Formoflo MDI 250: Administer one puff twice daily (morning
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender between 18-65 years of age (both inclusive) 2. Patients with mild to moderate asthma not receiving any regular controller medication since last 12 weeks 3. Patients with bronchodilator reversibility i.e., increase in FEV1 of = 12% and = 200 ml after salbutamol inhalation at screening 4. Pre-bronchodilator FEV1 of 60% to 85% of the predicted normal value at screening 5. Patients with Asthma Control Test (ACT) score = 15 at screening 6. Patients willing to provide written informed consent and comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any ß2-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 = 3 x Upper Normal Limit) or renal dysfunction (serum creatinine 10. = 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: From Baseline (Day 0) to end of month 3 & 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FVC & ACT score & Asthma Quality of Life Questionnaire (AQLQ) scoreTimepoint: Baseline (Day 0) to month 3 & 6.;Number of adverse events, Serious adverse events & Asthma exacerbations reported during the studyTimepoint: From Baseline to end of study | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed