CTRI/2011/11/002176 [Registered on: 29/11/2011] Trial Registered Prospectively
Last Modified On:
31/12/2012
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 Beclomethasone in patients with Asthma
Scientific Title of Study
A Randomized, Open Label, Non- Inferiority, Comparative, Multicentric Study Between Beclomethasone Dipropionate 250 μg in HFA propelled MDI And Beclomethasone Dipropionate 250 μg in HFA propelled MDI (Clenil® HFA 250 μg Spray) in a 12-week Treatment Period of Adult Patients With Mild to Moderate Persistent Asthma
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GL-Bcl/2011-12
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Hyderabad Central Ethics Committee_Ashwini Hospitals
Approved
Hyderabad Central Ethics Committee_Axon Hospitals
Approved
Hyderabad Central Ethics Committee_Surya Chest Clinic
Approved
Hyderabad Central Ethics Committee_Usha Khandal Hospital
Approved
Institutional Ethics Committee, Jaipur_Mahatma Gandhi Medical College & Hospital
Submittted/Under Review
Institutional Ethics Committee_Medical College & Hospital Kolkata
Approved
Institutional Ethics Committee_Narayana Medical College Hospital
Approved
Institutional Ethics Committee_Saptagiri Institute of Medical Science and Research Centre
Approved
Institutional Ethics Committee_St. Theresa’s General Hospital
Approved
VZ Human Research Protection Care Ethics Committee_Dr Vasavi Clinic
Approved
VZ Human Research Protection Care Ethics Committee_Imma labs
Approved
VZ Human Research Protection Care Ethics Committee_Prahlada Poly Clinic
Approved
VZ Human Research Protection Care Ethics Committee_Sri chaitanya Clinic
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Asthma,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Beclomethasone Dipropionate, HFA propelled MDI
2 puffs, twice daily for 12 Weeks
Comparator Agent
Clenil®, HFA propelled MDI
2 puffs, twice daily for 12 Weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1. Male or female patient aged between 18 to 70 years with clinical diagnosis of mild to moderate asthma
2. The patient provides written informed consent to participate in the study
3. FEV1 between 60% and 80% of the predicted value
4. Patient willing to perform all study related procedures including the use of study inhalers, spirometer and peak flow meter.
5. Positive response to the reversibility test
6. Negative urine pregnancy test at screening visit, in women of child bearing age group and willing to use acceptable contraceptive measures during the study period or women who have been permanently sterilized or attained menopause. Male patients should use double barrier contraceptive measures
ExclusionCriteria
Details
1. Inability to carry out pulmonary function testing
2. Chronic Obstructive Pulmonary Disease (COPD)
3. Pregnant or lactating women
4. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
5. History of near fatal asthma exacerbation
6. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks
7. Active smoker
8. 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
9. Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, endocrinal, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
10. History of Diabetes mellitus
11. Clinically significant ECG Abnormality at baseline
12. History of alcohol or drug abuse
13. Known history of HPA axis disease or malfunctioning
14. Patients who have undergone major surgery in the previous 4 weeks
15. Participation in an investigational drug trial within 3 months of screening
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Mean difference between groups in FEV1 value at the End of Treatment Visit
12 weeks
Secondary Outcome
Outcome
TimePoints
Change in morning PEF
12 weeks
Change in asthma symptom score
12 weeks
Number of asthma exacerbations
12 weeks
Change in evening PEF
12 weeks
Change in Diurnal variability of PEF
12 weeks
Change in nocturnal asthma symptom
12 weeks
Average need for use of short acting β 2 agonists
12 weeks
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, non-Inferiority, multicenteric study. The study will be conducted in adult patients with a diagnosis of mild to moderate persistent asthma with an FEV1 of 60% to 80% of the predicted value. Study will enroll 280 patients across different centers from India.
Patients will be recruited after providing written informed consent. After screening and run in period, patient will be randomized (patient meeting randomization criteria) in 1:1 ratio to receive either Beclomethasone Dipropionate 250 μg in HFA propelled MDI or Beclomethasone Dipropionate 250 μg in HFA propelled MDI (Clenil® HFA 250 μg 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 (12 weeks). Secondary objective includes Change in PEF, asthma symptoms, number of asthma exacerbations, average need for use of short acting β 2 agonists and safety. Patients will be followed for safety and efficacy assessment at week 4, 8 and 12 after start of therapy.