None listed
Conditions
Interventions
Roflumilast Type of group
One tablet of Rofluminast 500 mcg once a day in the morning after breakfast with at least 20 mL of liquid.
Group name:Placebo Type of group
A placebo tablet is administered once a day in the morning after breakfast with at least 20 mL of fluid.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women between 45 and 80 years old 2. A diagnosis of COPD performed by a doctor based on the criteria of the national health institutes The characteristic symptoms of COPD are chronic cough, chronic sputum production, and dyspnea. 3. FEV1 / CVF1 post bronchodilator <70% prediction. 4. A post-bronchodilator FEV1 / CVF1 which is between 30% to <80% of the prediction. 5. A post-bronchodilator FEV1 / CVF1 with an increase <12% and / or <200mL compared with the pre-bronchodilator value. 6. A Grade 1 score or higher on the MRC´s dyspnea scale. 7. Stable COPD without any change in treatment in 4 weeks previous 8. Absence of concomitant pulmonary disease (cystic fibrosis, deficiency of alpha 1-antitrypsin, active tuberculosis, pulmonary fibrotic disease, or primary bronchiectasis), previous thoracotomies or pulmonary resections. 9. Availability of a chest x-ray plate taken at 12 months before the selection. 10. Have obtained signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Regular need for daily oxygen-therapy. 2. Suspected hypersensitivity to the PDE4 inhibitor. 3. Having completed or initiated pulmonary rehabilitation therapy in a 3 month period or early initiation during the course of the study. 4. Clinical diagnosis of asthma. 5. X-ray of the chest (within the previous 12 months) suggesting active pulmonary diseases and not COPD. 6. If the patient has a history of active malignancy or of any type. 7. Active hepatitis; history of HIV infection. 8. Renal, cardiac, or hepatic abnormalities clinically significant, including renal failure (creatinine> 1.8) or the presence of cor pulmonale. 9. Positive test for fecal occult blood in the selection or 2 weeks previous 10. Pregnancy, lactation, or absence of effective contraception in women with reproductive potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:VEF1 Measure:Efectos de roflumilast de 500 mcg OD y placebo en la funcion pulmonar (VEF1) en pacientes con EPOC. Timepoints:24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Significant changes in the weekly average of bronchodilator (short-acting) supplementary use as rescue medications as indicated by baseline electronic diaries and consecutive visits. Measure:To assess the safety and tolerability of rofluminast in patients with COPD Timepoints:24 week | — |
Countries
Argentina, Canada, Colombia, Mexico, Peru, United States
Outcome results
None listed