ROFLU2011: Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily
Study Details
Study Description
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 the administration of roflumilast 500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks (phasing). In the control group assigned to undertake the treatment according to the standard dosage (roflumilast 500μg od).
The patient monitoring will be done by one of the sub-investigators fully independent team that started the medication keeping the pattern masking by single blind, and since it aims to assess the frequency of adverse events (AEs) in both groups were collected systematically different AEs and their characteristics at 15 days (V1), and from that moment a month (V2) and 2 months (V3). Likewise, other data collected (functional demographic, comorbidities, home treatment, anxiety and depression and quality of life).
The purpose of this study is to assess whether the administration of roflumilast by a gradual pattern varies the incidence of discontinuations due to adverse events when compared with the usual dosage.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Roflumilast alternated days Intervention: 500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks |
Drug: Roflumilast alternated days
500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks
Other Names:
|
| Active Comparator: Roflumilast 500 mcg per day Roflumilast 500μg standard dosage |
Drug: Roflumilast 500 mcg per day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Difference of Adverse Events [2 weeks]
Difference in the proportion of patients who leave the study for AEs between the control group (roflumilast 500μg od) and intervention (roflumilast 500μg eod)
Secondary Outcome Measures
- Patients who leave the study [two weeks]
Difference in the proportion of patients who leave the study for AEs between the control group (roflumilast 500μg od) alternating pattern (in patients with impaired tolerance) and intervention (roflumilast 500μg eod) between visits V2 and V0.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of COPD in severe degree GOLD criteria, assessed by post-bronchodilator spirometry (FEV1 <50%, FEV1/Forced vital capacity (FVC) <70% of theory).
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Age over 18 years.
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Productive cough recurrently most days for at least three months a year and at least 2 consecutive years.
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History from smoking prior> 15 to 20 packs / year.
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An exacerbation in the previous year.
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Stability clinic in the last 30 days.
Exclusion Criteria:
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Pregnancy / breastfeeding.
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Acute infections.
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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.
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Patients cachectic or the risk of cachexia.
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HIV infection.
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Severe immune Infections (systemic lupus erythematosus, multiple sclerosis, etc.).
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Gastroesophageal reflux symptoms and diagnosis established.
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Hiatal hernia.
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Peptic ulcer disease.
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Inflammatory bowel pathology.
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Neoplastic pathology: current diagnosis of cancer other than basal cell or squamous cell carcinoma of the skin.
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Moderate to severe hepatic impairment (Child-Pugh BC).
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Inability to understand / perform the techniques.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Jerez | Jerez de la Frontera | Cádiz | Spain | |
| 2 | Hospital Universitario Reina Sofía | Córdoba | Spain | ||
| 3 | H.U. Virgen de las Nieves | Granada | Spain | ||
| 4 | Hospital Universitario Virgen Macarena | Sevilla | Spain |
Sponsors and Collaborators
- Fundación Pública Andaluza Progreso y Salud
Investigators
- Study Chair: Teodoro Montemayor Rubio, M.D. Ph D, Hospital Universitario Virgen Macarena
- Principal Investigator: Ruth Ayerbe, M.D, Complejo Hospitalario de Especialidades Juan Ramón Jimenez
- Principal Investigator: Gregorio Soto, M.D., Hospital de Jerez
- Principal Investigator: Francisco L Muñoz, M.D., Hospital Universitario Reina Sofía
- Principal Investigator: Concepción Morales, M.D., H.U. Virgen de las Nieves
- Principal Investigator: José L de la Cruz, M.D., Complejo Hospitalario Carlos Haya
- Principal Investigator: Cristina García, M.D., Hospital Universitario de Puerto Real
- Principal Investigator: Bernardino Alcázar, M.D., HAR de Loja
- Principal Investigator: Rosa Vazquez, M.D., Hospital Infanta Elena
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ROFLU2011