CTRI/2018/02/011953招募中4 期
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.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- No secondary outcome(none)
研究者
研究点 (1)
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