Efficacy of Roflumilast in Treatment of Severe Asthma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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