EUCTR2011-002101-29-DE进行中（未招募）不适用
A randomised, double-blind, 4-weeks cross-over trial to investigate the effect of 500 µg roflumilast tablets once-daily versus placebo on pulmonary function, asthma symptoms and inflammatory markers in subjects with asthma not adequately controlled with a combination of at least medium dose ICS/LABA maintenance therapy. - Efficacy of Roflumilast in Treatment of Severe Uncontrolled Asthma
ycomed GmbH0 个研究点目标入组 110 人开始时间: 2011年7月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Written informed consent.
- •- Age 18 years or above.
- •- Documented physician diagnosis of severe asthma consistent with the Global Initiative for Asthma (GINA) clinical features (step 4) for at least 6 months.
- •- Treated with a fixed or free combination of at least medium-dose ICS plus LABA for at least 3 months prior to baseline period with stable treatment for at least 4 weeks before Visit (V2).
- •- GINA-defined uncontrolled asthma or an asthma control questionnaire (ACQ-7) score = 1.5 despite at least medium dose ICS/LABA therapy within 4 weeks prior to baseline (V0).
- •- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40–85% of predicted at V0. For subjects participating in the sputum sub-study only: FEV1 > 55% of predicted and > 1 Litre.
- •- Non-smokers or ex-smokers (defined as: smoking cessation at least 1 year ago) with a smoking history of =10 pack years.
- •- Airway obstruction proven to be reversible by an improvement of FEV1 of at least 12% and 200 ml after inhalation of a short-acting bronchodilator. This can be either documented in the medical history (with supporting spirometry recordings) in the previous 12 months or demonstrated during screening.
- •- Subjects who, with the exception of asthma, are in good health.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Severe asthma exacerbation2 not resolved 4 weeks prior to baseline visit V0.
- •- Lower respiratory tract infection not resolved 4 weeks prior to baseline visit V0.
- •- A diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on GOLD criteria and/or other relevant forms of lung disease (e.g. history of primary bronchiectasis, cystic fibrosis, idiopathic (pan)bronchiolitis or bronchiolitis obliterans, bronchopulmonary allergic aspergillosis, Churg-Strauss Syndrome, paradoxical vocal cord closure, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], or active tuberculosis) that may interfere with the evaluation of a treatment response.
- •- Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding V0.
- •- History of clinically significant allergies or idiosyncrasies to roflumilast, or any inactive ingredient(s) of these products.
- •- History of severe allergy to any drugs, food or beverages.
- •- Females of childbearing potential3 not willing to use acceptable contraceptive methods such as hormonal contraceptives (oral, injection or implant) or intrauterine contraceptive devices or who started such methods less than 2 months prior to screening or who are not willing to use a double barrier method of contraception (diaphragm plus condom).
- •- Lactating or pregnant females. A positive pregnancy test before the first administration of investigational medicinal product or breastfeeding.
- •- Male subjects planning to father during clinical trial conduct or within 3 months after the last planned dose of trial treatment.
- •- Planned donation of germ cells, blood, organs or bone marrow during the course of the trial.
- •- Subjects previously enrolled in the current clinical trial (see Section 5.7 of the protocol: Replacement and re-enrolment policy for replacement and re-enrolment policy).
- •- Suffering from concomitant disease or condition including those that might interfere with trial procedures or evaluations.
- •- Use of disallowed drugs listed in Section 6.8.2 of the protocol: Disallowed medication.
研究者
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