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

NCT01849341 | Completed Phase 4 DMC

• 1 other identifier: ROFLU2011
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 4

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)

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Difference of Adverse Events

  Difference in the proportion of patients who leave the study for AEs between the control group (roflumilast 500μg od) and intervention (roflumilast 500μg eod)

  2 weeks

Secondary Outcomes (1)

• Patients who leave the study

  two weeks

Study Arms (2)

Roflumilast alternated days

EXPERIMENTAL

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

Drug: Roflumilast alternated days

Roflumilast 500 mcg per day

ACTIVE COMPARATOR

Roflumilast 500μg standard dosage

Drug: Roflumilast 500 mcg per day

Interventions

Roflumilast alternated days DRUG

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

Also known as: schedule change

Roflumilast alternated days

Roflumilast 500 mcg per day DRUG

Also known as: Standard dosage

Roflumilast 500 mcg per day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza Progreso y Salud: lead

Study Sites (4)

Hospital de Jerez

Jerez de la Frontera, Cádiz, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Location

H.U. Virgen de las Nieves

Granada, Granada, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Teodoro Montemayor Rubio, M.D. Ph D

  Hospital Universitario Virgen Macarena

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

ES (4)