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CTRI Number  CTRI/2018/02/011953 [Registered on: 19/02/2018] Trial Registered Retrospectively
Last Modified On: 10/10/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized Factorial Trial 
Public Title of Study   A clinical trial to understand changes in exhaled breath and lung function tests with different doses of inhaled steroid (Beclomethasone dipropionate) in moderate to severe asthma patients. 
Scientific Title of Study   A randomized, double-blind, double-dummy, placebo-controlled, study to compare therapeutic effects of 50 mcg, 100 mcg and 200 mcg beclometasone dipropionate (QVAR 50 mcg of Teva UK Limited), on Fractionated exhaled Nitric Oxide (FeNO), Impulse oscillometry parameters and Lung volumes in subjects with asthma.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sundeep Salvi 
Designation  Principal Investigator 
Affiliation  Chest Research Foundation 
Address  Chest Research Foundation, 15, Marigold Premises, Kalyani Nagar, Pune

Pune
MAHARASHTRA
411014
India 
Phone  9921211000  
Fax    
Email  ssalvi@crfindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sundeep Salvi 
Designation  Director  
Affiliation  Chest Research Foundation 
Address  Clinical Research Division, Room No. 1, Chest Research Foundation, 15, Marigold Premises, Kalyani Nagar, Pune
Chest Research Foundation, 15, Marigold Premises, Kalyani Nagar, Pune
Pune
MAHARASHTRA
411014
India 
Phone  9921211000  
Fax  9921211000  
Email  ssalvi@crfindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Sundeep Salvi 
Designation  Director  
Affiliation  Chest Research Foundation 
Address  Clinical Research Division, Room No. 1, Chest Research Foundation, 15, Marigold Premises, Kalyani Nagar, Pune
Chest Research Foundation, 15, Marigold Premises, Kalyani Nagar, Pune
Pune
MAHARASHTRA
411014
India 
Phone  9921211000  
Fax  9921211000  
Email  ssalvi@crfindia.com  
 
Source of Monetary or Material Support  
Chest Research Foundation, 15 Marigold Premises, Kalyani Nagar, Pune 411014, Maharashtra India 
 
Primary Sponsor  
Name  Chest Research Foundation 
Address  15, Marigold Premises, Kalyani Nagar, Pune 411014, Maharshtra India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Cipla Ltd India  Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400013, India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sundeep Salvi  Chest Research Fondation  Clinical Research Division, Room No. 25, Chest Research Foundation 15, Marigold Premises Kalyaninagar Pune
Pune
MAHARASHTRA 		 9921211000

ssalvi@crfindia.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Asthma, (1) ICD-10 Condition: J45||Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Beclomethasone inhaler  1 respiratory inhalation of 50 mcg per day for 7 days 
Intervention  Beclomethasone inhaler  2 respiratory inhalations of 50 mcg each per day for 7 days 
Intervention  Beclomethasone inhaler  4 respiratory inhalations of 50 mcg each per day for 7 days 
Comparator Agent  Placebo inhaler  1 respiratory inhalation per day for 7 days 
Comparator Agent  Placebo inhaler  2 respiratory inhalations per day for 7 days 
Comparator Agent  Placebo inhaler  4 respiratory inhalations per day for 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects who have signed informed consent form before initiation of any study related procedure. Subjects diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP) and diagnosed minimum of 6 months prior to screening. FeNO value of 50 parts per billion or more at screening visit. Subjects able to perform acceptable IOS technique as per guidelines.Subjects with pre-bronchodilator FEV1 of 45% to 85% (both inclusive) of the predicted normal value at the screening visit (V1). Subjects who demonstrated an increase of ≥12% and >200 mL over pre-bronchodilator FEV1 between 10-20 minutes following 400 mcg of salbutamol inhalation (pMDI). Reversibility assessment performed within 1 year prior to V1, will be acceptable. If historic data is not available, then it will be done on the same day or separate day after proper medication washout based on the investigator’s discretion. If failed to demonstrate reversibility, only one re-test is allowed within 3 days with a gap of at least 24 hours between two tests. Subjects who agree to abstain from consuming nitrate-rich products for at least 4 hours prior to FeNO measurements. Subjects who are non-smokers or ex-smokers and have had less than 10 pack years smoking history. Subjects who are stable on current asthma treatment for at least 4 weeks prior to screening. Subjects who are steroid-naïve i.e. subjects who never took steroids or have not taken any oral or inhaled steroid 4 weeks prior to screening. Subjects who are able to replace their current short acting bronchodilator inhaler with the study provided salbutamol inhaler to be used as rescue medicine as needed throughout the study.
 
 
ExclusionCriteria 
Details  History of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s) within the past one year. Any treatment changes due to deterioration of asthma within 6 weeks of screening. Any asthma exacerbation requiring emergency room visits or systemic corticosteroids within 6 months of the treatment (i.e. severe exacerbations). A subject has had any hospitalization for asthma within 6 months prior to the screening visit (V1). Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, myocardial infarction, known aortic aneurysm, clinically significant cardiac dysrhythmia or coronary heart disease), hepatic, renal, haematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, addison’s disease, cushing’s syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, gastroesophageal reflux disease), or pulmonary (e.g., bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, chronic obstructive pulmonary disease) or obstructive sleep apnoea. Subjects with current malignancies except basal cell carcinoma, stroke within the last 3 months, immunologically compromised patients, currently evident bronchopulmonary dysplasia and any history of tuberculosis (including but not limited to) that, in investigator’s judgment, might cause participation in study to be detrimental to the subject. Clinical visual evidence of oral candidiasis at the screening visit. History of any adverse reaction; hypersensitivity to any sympathomimetic drug (e.g., salmeterol or salbutamol) or any inhaled, intranasal, or systemic corticosteroid (e.g. BDP) therapy or any other constituents of the IPs. Subjects receiving β2-blockers, anti-arrhythmics, anti-depressants and monoamine oxidase inhibitors within 4 weeks prior to screening. Recent viral or bacterial infection or infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 4 weeks of screening. In addition, the subjects who develop a respiratory tract infection before the randomised visit (V2) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of infection. Subject has any clinically significant abnormalities in chemistry, haematology, or other laboratory tests at screening (as determined by the Investigator). Use of systemic, oral, intra-articular or depot corticosteroids within 2 months prior to the screening except topical steroids used for dermatological indications. Use of immunosuppressive medications within 4 weeks prior to the screening and during the study. Use of potent cytochrome P450 3A4 (CYP3A4) inhibitors within 4 weeks prior to screening. Factors (e.g., infirmity, disability or geographic location) that the investigator felt would likely limit the subjects’ compliance with the study protocol or scheduled clinic visits. Use of any investigational drug (approved or unapproved) within 30 days or 5 half-lives (whichever is longer) preceding the screening or planned participation in another investigational drug study at any time during this study. Pregnant women. Subjects unwilling to practice contraception throughout the study duration. Study participation by clinical investigator site employees and/or their immediate relatives. Subjects unable to use pMDI with optimal technique or comply with the study regimen.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The change from baseline in FeNO after 168 hrs of treatment. The change from baseline in IOS parameter i.e. R5-20 Hz, after 1 week of treatment. The change from baseline in the FEV1 and FEF25%-75% on spirometry after 1 week of treatment.

 		 The change from baseline in FeNO after 168 hrs of treatment. The change from baseline in IOS parameter i.e. R5-20 Hz, after 1 week of treatment. The change from baseline in the FEV1 and FEF25%-75% on spirometry after 1 week of treatment.

 
 
Secondary Outcome  
Outcome  TimePoints 
No secondary outcome  none 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/05/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Asthma is a chronic inflammatory disease and inhaled corticosteroids (ICS) are the most important treatment. However, present tools to assess response to ICS are unable to differentiate between two doses of ICS which is leading to difficulty in clinical practice in deciding the exact dose of ICS required to control inflammation in asthma. Hence there is a need for new tools. Fractionated exhaled Nitric Oxide (FeNO) and Impulse Oscillometry (IOS) have been suggested as possible tools and spirometry is the most commonly used tool. The specific aim of this pilot study is thus to examine changes in FeNO, IOS and spirometry by 1 week treatment of 50, 100 and 200 mcg of BDP once daily. Hence, this study is being conducted to compare the three tools in their ability to differentiate between response of different doses of ICS. 
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