Efficacy of Roflumilast and Montelukast in the treatment of severe uncontrolled asthma

• Conditions: Pulmonary Function, Asthma Symptoms and Inflammatory Markers in Subjects with Severe Asthma; MedDRA version: 15.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-002064-27-DE
• Lead Sponsor: Takeda Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-27
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. The subject has a documented physician diagnosis of severe asthma consistent with Global Initiative for Asthma (GINA 2011) step 4 clinical features for at least 6 months prior to Visit 1.
2. The subject has been treated with a fixed or free combination of at least medium-dose ICS (ie, =250 µg fluticasone propionate daily or equivalent ICS) plus LABA for at least 3 months prior to Baseline Visit 1 and a stable ICS dose for at least 4 weeks before Visit 2.
3. The subject shows 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 at both Visit 1 and Visit 2.
4. The subject shows a pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >55% and = 85% of predicted at Visit 1. For subjects performing induced sputum FEV1 must be in addition >1 liter.
5. Subject has 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 may be documented either in the medical history (with supporting spirometry recordings) in the previous 12 months or demonstrated during Screening.

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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Severe asthma exacerbation not resolved 4 weeks prior to Baseline Visit 1, (defined by the need for oral or parenteral glucocorticosteroid intake for at least 3 days and/or hospitalization or emergency room visit with the need for oral or parenteral corticosteroid use).
2. Lower respiratory tract infection not resolved 4 weeks prior to Baseline Visit 1.
3. A diagnosis of chronic obstructive pulmonary disease (based on GOLD criteria) and/or other relevant forms of lung disease (eg, 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 [eg, fibrosis, silicosis, sarcoidosis], or active tuberculosis) that may interfere with the evaluation of a treatment response.
4. Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified