A clinical trial to study fixed dose combination of Formoterol fumarate & Mometasone furoate dry powder inhaler and fixed dose combination of Formoterol fumarate & Budesonide dry powder inhaler in patients with bronchial asthma and/or chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J459||Other and unspecified asthma,
- Registration Number
- CTRI/2009/091/000111
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination of Formoterol fumarate & Mometasone furoate Dry Powder Inhaler (DPI) and fixed-dose combination of Formoterol fumarate & Budesonide Dry Powder Inhaler (DPI) two respicaps twice daily each in 200 patients with bronchial asthma and/or chronic obstructive pulmonary disease (COPD) that will be conducted in India. The primary outcome measures will be degree of improvement in PEFR at each visit and at the end of the study as compared to baseline.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
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.
1.Pregnancy and/or lactation2.Patients with severe or recently unstable bronchial asthma or status asthmaticus3.Patients requiring nebulized therapy or oral corticosteroids4.Patients with active or quiescent tuberculosis infection, glaucoma, untreated systemic fungal, bacterial, viral or parasitic infections or ocular herpes simplex5.Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment6.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 study7.Patients with history of known hypersensitivity to formoterol fumarate or mometasone furoate or budesonide or salbutamol or any component of the formulations8.Patients with any other serious concurrent illness or malignancy9.Patients with continuing history of alcohol and/or drug abuse10.Participation in another clinical trial in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degree of improvement in PEFR at each visit and at the end of the study as compared to baseline 1-4 weeks
- Secondary Outcome Measures
Name Time Method 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 baseline 1-4 weeks
Trial Locations
- Locations (5)
ASHRAI ASSOCIATES, Ahmedabad
🇮🇳Ahmadabad, GUJARAT, India
Chest & TB Hospital
🇮🇳Jaipur, RAJASTHAN, India
Indore Chest Centre, Indore
🇮🇳Indore, MADHYA PRADESH, India
L.T.M. Medical College & L.T.M.G.H.
🇮🇳Mumbai, MAHARASHTRA, India
Mahatma Gandhi National Institute of Medical Sciences, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
ASHRAI ASSOCIATES, Ahmedabad🇮🇳Ahmadabad, GUJARAT, IndiaDr. Tushar B. PatelPrincipal investigator079-26579550drtusharpatel@yahoo.com