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.
- Conditions
- Health Condition 1: null- AsthmaHealth Condition 2: J45- Asthma
- Registration Number
- CTRI/2018/02/011953
- Lead Sponsor
- Chest Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 investigatorâ??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.
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, addisonâ??s disease, cushingâ??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 investigatorâ??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 subjectsâ?? 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br> <br/ ><br>Timepoint: 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. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method o secondary outcomeTimepoint: none