CTRI/2012/10/003073 [Registered on: 26/10/2012] Trial Registered Prospectively
Last Modified On:
20/06/2013
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the effects of Fixed Dose Combination of Salbutamol & Beclometasone Pressurized Inhalation in patients With Stable Persistent Asthma
Scientific Title of Study
A Randomized, Open Label, Non- Inferiority, Comparative, Multicentric, Parallel group Study Between Fixed Dose Combination of Salbutamol & Beclometasone Pressurized Inhalation CFC Free 100+50mcg/actuation and HFA Propelled pMDI Salbutamol 100 mcg + Beclometasone 50mcg (Clenil Compositum ®HFA spray) in Patients With Stable Persistent Asthma
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GPL/CT/2011/013/III, version no.2.0, dated: 26.09.2012
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Takiya Shah Ali Nehri, Near Hotel Moon Light, Nutan Colony, Aurangabad- 431001 Aurangabad MAHARASHTRA
9823004246
drmasood.cr@gmail.com
Dr S Nagarajan
Coimbatore Chest Clinic
M.S.S Memorial Building.No.8
D .B Road, R S Puram , Coimbatore ,
Tamil Nadu -641002
Coimbatore TAMIL NADU
9443055740
nagrajsri@gmail.com
Dr BR Shivakumar
Cosmopolitan Medical Centre
Department of Clinical Research, NO.8, 5 th Main Mariappa Road (Kullappa Circle), Kammanahalli, St.Thomas Town Post,Bangalore-560084,Karnataka,India. Bangalore KARNATAKA
Synapse Ethics Committee,Cosmopolitan Medical Centre, Bangalore
Approved
Vijay Nursing Home IRB,Vijay Nursing Home, Nashik
Submittted/Under Review
Vintage Institutional Ethics Committee,Vintage Hospital & Medical Research Centre, Goa
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Asthma,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Salbutamol & Beclometasone Pressurized Inhalation
2 puffs thrice daily for 10 days
Comparator Agent
Salbutamol + Beclometasone HFA spray
2 puffs thrice daily for 10 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1. 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
ExclusionCriteria
Details
1. 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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Mean difference between groups in FEV1 value at the End of Treatment Visit
10 days
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="280" Sample Size from India="280" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This
is a randomized, open label, comparative, parallel group, non inferiority,
multicentric study. The study will be conducted in adult patients with a
diagnosis of Stable Persistent Asthma with an FEV1 of ≥70% to ≤90% of the
predicted value. Study will enrol 280 patients across different centers from
India.
Patients
will 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 HFA
Propelled pMDI Salbutamol 100 mcg + Beclometasone 50mcg (Clenil Compositum ®HFA
spray).
The primary objective of the study is to
evaluate the effect of study drug on lung function as assessed by FEV1 after
the therapy. Secondary objective includes Change in PEF, asthma symptoms,
average need for use of short acting β2 agonists and safety.