Status:
COMPLETED
Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily
Lead Sponsor:
Fundación Pública Andaluza Progreso y Salud
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
It is a phase IV clinical trial: longitudinal, prospective, evaluator-blind, randomized into 2 groups of patients with chronic obstructive pulmonary disease (COPD). The intervention group was based on...
Eligibility Criteria
Inclusion
- Diagnosis of COPD in severe degree GOLD criteria, assessed by post-bronchodilator spirometry (FEV1 \<50%, FEV1/Forced vital capacity (FVC) \<70% of theory).
- Age over 18 years.
- Productive cough recurrently most days for at least three months a year and at least 2 consecutive years.
- History from smoking prior\> 15 to 20 packs / year.
- An exacerbation in the previous year.
- Stability clinic in the last 30 days.
Exclusion
- Pregnancy / breastfeeding.
- Acute infections.
- Patients with severe mental disorder or uncontrolled, in the opinion of the investigator, would make the patient has a higher risk due to their participation in the study, could be a confounding factor in the study's results or is likely to prevent that the patient meets the requirements of the study or to complete the study.
- Patients cachectic or the risk of cachexia.
- HIV infection.
- Severe immune Infections (systemic lupus erythematosus, multiple sclerosis, etc.).
- Gastroesophageal reflux symptoms and diagnosis established.
- Hiatal hernia.
- Peptic ulcer disease.
- Inflammatory bowel pathology.
- Neoplastic pathology: current diagnosis of cancer other than basal cell or squamous cell carcinoma of the skin.
- Moderate to severe hepatic impairment (Child-Pugh BC).
- Inability to understand / perform the techniques.
- Home treatment with theophylline, methotrexate, azathioprine, infliximab, etanercept, inducers of cytochrome P450 (eg, rifampicin, phenobarbital, carbamazepine, phenytoin),cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin and ketoconazole), oral contraceptives (gestodene and ethinyl estradiol), making prolonged oral corticosteroids, or a drug that contains fluvoxamine, enoxacin and cimetidine.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01849341
Start Date
July 1 2012
End Date
July 1 2014
Last Update
July 8 2015
Active Locations (4)
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1
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain
2
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
3
H.U. Virgen de las Nieves
Granada, Granada, Spain
4
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain