A clinical trial to study the effects of Fixed Dose Combination of Salbutamol & Beclometasone Pressurized Inhalation in patients With Stable Persistent Asthma
- Conditions
- Asthma
- Registration Number
- CTRI/2012/10/003073
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Thisis a randomized, open label, comparative, parallel group, non inferiority,multicentric study. The study will be conducted in adult patients with adiagnosis of Stable Persistent Asthma with an FEV1 of ≥70% to ≤90% of thepredicted value. Study will enrol 280 patients across different centers fromIndia.
Patientswill be recruited after providing written informed consent. After screening,patient will be randomized in 1:1 ratio to receive either Salbutamol &Beclometasone Pressurized Inhalation CFC Free 100+50mcg/actuation or HFAPropelled pMDI Salbutamol 100 mcg + Beclometasone 50mcg (Clenil Compositum ®HFAspray).
The primary objective of the study is toevaluate the effect of study drug on lung function as assessed by FEV1 afterthe therapy. Secondary objective includes Change in PEF, asthma symptoms,average need for use of short acting β2 agonists and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 280
- Male or female outpatients aged ≥18 to ≤70 years inclusive, with stable persistent asthma 2.
- Clinical diagnosis of asthma for at least 6 months prior to screening and FEV1 ≥70 % to ≤90% of predicted normal value 3.
- Patients able to demonstrate at least 12% improvement in FEV1 and 200ml after 30 minutes (±10mins) after inhalation of Salbutamol 400μg 4.
- Patient willing to perform all study related procedures including the use of study inhalers, Spirometry and peak flow meter and willing to complete the patient diary.
- COPD as defined by the European Respiratory Society (ERS) – Consensus Statement; 2.
- Patients with more than 10 packs/year of cigarettes history and current smokers 3.
- Patients with a history of hypersensitivity to salbutamol/beclomethasone and or any other ingredients 4.
- History of near fatal asthma and/or admission in intensive care unit because of asthma 5.
- Female subjects who are pregnant, nursing or planning a pregnancy during the study 6.
- Patient has any uncontrolled systemic disease or patient has had any major surgery within 4 weeks of study start 7.
- History of alcohol and/or substance abuse within 12 months prior to the Screening Visit 8.
- Subjects who have participated in another investigational drug or device research study within 30 days of enrollment 9.
- Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference between groups in FEV1 value at the End of Treatment Visit 10 days
- Secondary Outcome Measures
Name Time Method Mean change in PEFR from baseline to end of treatment 10 days Improvement of asthma symptoms (symptom scores) 10 days Need for short acting beta 2 agonist as rescue inhalation 10 days Nocturnal asthma (nocturnal awakening because of asthma) 10 days Patient and Investigator global impression 10 days
Trial Locations
- Locations (35)
Aashish Chest Clinic
🇮🇳Vadodara, GUJARAT, India
Apex Hospitals Private Limited
🇮🇳Jaipur, RAJASTHAN, India
Care Institute of Medical Sciences
🇮🇳Ahmadabad, GUJARAT, India
Centre for Chest Diseases, Allergy & Sleep Disorders
🇮🇳Delhi, DELHI, India
Chaitanya Hospital
🇮🇳Dhule, MAHARASHTRA, India
Chest Clinic
🇮🇳Aurangabad, MAHARASHTRA, India
Coimbatore Chest Clinic
🇮🇳Coimbatore, TAMIL NADU, India
Cosmopolitan Medical Centre
🇮🇳Bangalore, KARNATAKA, India
Department of Medicine, IPGMER
🇮🇳Kolkata, WEST BENGAL, India
Dr. Hedgewar Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Scroll for more (25 remaining)Aashish Chest Clinic🇮🇳Vadodara, GUJARAT, IndiaDrAshish A KadakiaPrincipal investigator9377039595aashishurvi@rediffmail.com