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Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily (ROFLU2011)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01849341
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE May 8, 2013
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE July 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
Difference of Adverse Events [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
Differntes of Adverse Eventes [ Time Frame: 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
Patients who leave the study [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
Patiens who leave the study [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily
Official Title  ICMJE Clinical Trial Phase III Blind, Parallel Group to Analyze Differences in the Safety of Roflumilast Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: Roflumilast alternated days
    500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks
    Other Name: schedule change
  • Drug: Roflumilast 500 mcg per day
    Other Name: Standard dosage
Study Arms  ICMJE
  • Experimental: Roflumilast alternated days
    Intervention: 500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks
    Intervention: Drug: Roflumilast alternated days
  • Active Comparator: Roflumilast 500 mcg per day
    Roflumilast 500μg standard dosage
    Intervention: Drug: Roflumilast 500 mcg per day
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
105
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2013)
300
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01849341
Other Study ID Numbers  ICMJE ROFLU2011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )
Study Sponsor  ICMJE Fundación Pública Andaluza Progreso y Salud
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Andalusian Network for Design and Translation of Advanced Therapies
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP