Health Condition 1: null- Bronchial asthma and/or chronic obstructive pulmonary disease (COPD) Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 3: J459- Other and unspecified asthma
Conditions
Interventions
g) respicaps for Dry Powder Inhaler (DPI): Two respicaps BD
Intervention1: Fixed-dose combination of Formoterol fumarate (6 µg) & Mometasone furoate (200 µg) respicaps for Dry Powder Inhaler (DPI): Two respicaps BD
Control Intervention1: Fixed-dose combinati
g) &
Budesonide (200 µ
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients between 18-65 years of age 2.Patients with an established diagnosis of bronchial asthma and/or chronic obstructive pulmonary disease (COPD) requiring a combination of long acting beta 2-agonists and inhalation corticosteroids 3.Informed consent of the patient/relative
Exclusion criteria
Exclusion criteria: 1. Pregnancy and/or lactation 2. Patients with severe or recently unstable bronchial asthma or status asthmaticus 3. Patients requiring nebulized therapy or oral corticosteroids 4. Patients with active or quiescent tuberculosis infection, glaucoma, untreated systemic fungal, bacterial, viral or parasitic infections or ocular herpes simplex 5. Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment 6. Patients with any significant disease of any other organ system (renal, hepatic, cardiovascular, neurologic etc.) that could interfere with the study or require treatment which might interfere with the study 7. Patients with history of known hypersensitivity to formoterol fumarate or mometasone furoate or budesonide or salbutamol or any component of the formulations 8. Patients with any other serious concurrent illness or malignancy 9. Patients with continuing history of alcohol and/or drug abuse 10. Participation in another clinical trial in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of improvement in PEFR at each visit and at the end of the study as compared to baselineTimepoint: 1-4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The degree of improvement in the day-time and the night-time asthma symptoms (cough, wheeze, chest tightness, and shortness of breath) score as assessed on a 4-point scale as mentioned above at each visit and at the end of the study as compared to baselineTimepoint: 1-4 weeks | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Cadila Healthcare Ltd.
Outcome results
None listed