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

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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 Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )

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
Chronic Obstructive Pulmonary Disease (COPD) Drug: Roflumilast alternated days Drug: Roflumilast 500 mcg per day Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: 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
Study Start Date : July 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

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 Name: schedule change

Active Comparator: Roflumilast 500 mcg per day
Roflumilast 500μg standard dosage
Drug: Roflumilast 500 mcg per day
Other Name: Standard dosage




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849341


Locations
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Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
H.U. Virgen de las Nieves
Granada, Spain
Hospital Universitario Virgen Macarena
Sevilla, Spain
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
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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

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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01849341     History of Changes
Other Study ID Numbers: ROFLU2011
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud ):
COPD

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases