Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily

NCT ID: NCT01849341

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Roflumilast alternated days

Intervention: 500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks

Group Type: EXPERIMENTAL

Roflumilast alternated days

Intervention Type: DRUG

500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks

Roflumilast 500 mcg per day

Roflumilast 500μg standard dosage

Group Type: ACTIVE_COMPARATOR

Roflumilast 500 mcg per day

Intervention Type: DRUG

Interventions

Roflumilast alternated days

500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks

Intervention Type: DRUG

Roflumilast 500 mcg per day

Intervention Type: DRUG

Other Intervention Names

schedule change; Standard dosage

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teodoro Montemayor Rubio, M.D. Ph D

Role: STUDY_CHAIR

Hospital Universitario Virgen Macarena

Ruth Ayerbe, M.D

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario de Especialidades Juan Ramón Jimenez

Gregorio Soto, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital de Jerez

Francisco L Muñoz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofía

Concepción Morales, M.D.

Role: PRINCIPAL_INVESTIGATOR

H.U. Virgen de las Nieves

José L de la Cruz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Carlos Haya

Cristina García, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Puerto Real

Bernardino Alcázar, M.D.

Role: PRINCIPAL_INVESTIGATOR

HAR de Loja

Rosa Vazquez, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Infanta Elena

Locations

Hospital de Jerez

Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

H.U. Virgen de las Nieves

Granada, Granada, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Countries

Spain

Other Identifiers

ROFLU2011

Identifier Type: -

Identifier Source: org_study_id