The trial investigates the effect of 500 µg roflumiliast tablets once daily on acute worsening of symptoms (exacerbations) treated with standard therapy in patiens with chronic obstructive pulmonary disease (COPD)

Phase 1

• Conditions: Acute exacerbations of chronic obstructive pulmonary disease (COPD); MedDRA version: 16.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855; MedDRA version: 16.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-002905-31-GB
• Lead Sponsor: ycomed GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-19
• Study Completion: 2014-04-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 81

Inclusion Criteria

I1. Written informed consent (IC);
I2. Age =40 years;
I3. History of COPD for at least 12 months prior to enrolment (Visit V0);
I4. Chronic productive cough for 3 months in each of the 2 years prior to enrolment (if other causes of productive cough have been excluded) and/or an exacerbation with predominantly bronchitic symptoms at enrolment;
I5. Presentation of an acute exacerbation of COPD that will be associated with increased sputum volume or change in sputum colour;
I6. Documented fixed airway obstruction determined by an FEV1/FVC ratio (post-bronchodilator) <70% (if a pulmonary function test is not possible at Visit V0 a previous measurement can be taken which must not be older than 6 months);
I7. Former smoker (defined as: smoking cessation at least 1 year ago) or current smoker both with a smoking history of at least 10 pack years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

E1. Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis] or active tuberculosis);
E2. Known a-1-antitrypsin deficiency;
E3. Recurrent exacerbations (within 8 weeks of a preceding exacerbation);
E4. Treatment of current exacerbation with oral corticosteroids and/or antibiotics already started at enrolment;
E5. Treatment with PDE4 inhibitors within 3 months prior to Visit V0;

Criteria within ethical considerations in terms of general health:

E6. Oxygen therapy (more than 8 hours daily);
E7. Formal contraindications to sputum collection or impossibility to obtain a sample of sputum valid for analysis;
E8. Respiratory failure when presenting at Visit V0;
E9. Severe psychiatric or neurological disorders;
E10. History of depression associated with suicidal ideation or behaviour;
E11. Congestive heart failure severity grade IV according to the New York Heart Association Functional Classification;
E12. Haemodynamically significant cardiac arrhythmias or heart valve deformations;
E13. Immunological diseases or known infection with human immunodeficiency virus;
E14. Liver impairment Child-Pugh B and C and/or active viral hepatitis;
E15. Severe acute infectious diseases;
E16. Any diagnosis of a malignant disease (other than basal or squamous cell carcinoma) within 5 years before trial start;
E17. Alcohol or drug abuse within the past year;
E18. Suspected hypersensitivity to the IMP or ingredients thereof, or any other contraindication for the use thereof;
E19. Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire trial duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilised/hysterectomised or post-menopausal >1 year or who are not using any other method of contraception considered sufficiently reliable by the investigator in individual cases;
E20. Pregnancy, breast feeding, planned oocyte donation or oocyte implantation;
E21. Planned donation of germ cells, blood, organs or bone marrow during the course of the trial;
E22. Participation in another trial (use of investigational product) within 30 days of Visit V0 or re-entry of patients previously enroled in this trial;
E23. Suspected inability or unwillingness to comply with trial procedures (e.g. language problems, psychological disorders);
E24. Suffering from any concomitant disease that might interfere with trial procedures or evaluations;
E25. Use of disallowed drugs (see Section 6.8);
E26. Employee at the trial site, relative or spouse of the investigator.

Study & Design

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