Effect of roflumilast in COPD patients treated with tiotropium. A 24-week, double-blind study with 500 µg roflumilast once daily versus placebo. - HELIOS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

· Giving written informed consent
· Age >= 40 years
· History of chronic obstructive pulmonary disease for at least 12 months prior to baseline visit V0 (ATS/ERS 2005) and chronic productive cough for 3 months in each of the 2 years prior to baseline visit V0 (if other causes of productive cough have been excluded)
· FEV1/FVC ratio (post-bronchodilator) =< 70%
· FEV1 (post-bronchodilator) between >= 40 % and =< 70 % of predicted
· Fixed airway obstruction (defined as an FEV1 increase of =< 12 % or =< 200 ml after receiving 400 µg salbutamol)
· Patients must be pre-treated with tiotropium for at least 3 months prior to V0.
· Not suffering from any concomitant disease that might interfere with study procedures or evaluation
· Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years
· Availability of a High Resolution CT scan dated a maximum of 6 months prior to study baseline visit V0 or willingness to have a High Resolution CT scan performed during baseline, alternatively a CT scan or a x-ray will be accepted
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the baseline visit V0
· Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
· 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], and active tuberculosis)
· Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
· Known alpha-1-antitrypsin deficiency
· Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
· Known infection with HIV and/or active hepatitis
· Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within 5 years prior to study start
· Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray / CT-scan / ECG) that are not related to COPD and that require further evaluation
· Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
· Female patients of childbearing potential, who are not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female patients who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential
· Participation in another study (use of investigational product) within 30 days preceding the baseline visit V0 or re-entry if already enrolled in this trial
· Alcohol or drug abuse
· Inability to follow study procedures due to e.g. language problems, psychological disorders
· Use of disallowed drugs
· Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast or tiotropium) or rescue medication

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of 500µg roflumilast versus placebo once daily in COPD patients treated with tiotropium;Secondary Objective: To investigate the safety and tolerability of roflumilast in COPD patients treated with tiotropium;Primary end point(s): Mean change from randomization (V2) over 24 weeks of treatment in pre-dose study medication pre-bronchodilator FEV1

Secondary Outcome Measures

Name	Time	Method

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