Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00297102
First received: February 27, 2006
Last updated: May 4, 2012
Last verified: June 2011
  Purpose

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Roflumilast
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 52 weeks of treatment ] [ Designated as safety issue: No ]
    Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]

  • COPD Exacerbation Rate (Moderate or Severe) [ Time Frame: 52 weeks treatment period ] [ Designated as safety issue: No ]

    Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year.

    A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].



Secondary Outcome Measures:
  • Post-bronchodilator FEV1 [L] [ Time Frame: Change from baseline over 52 weeks of treatment ] [ Designated as safety issue: No ]
    Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]

  • Time to Mortality Due to Any Reason [ Time Frame: 52 weeks treatment period ] [ Designated as safety issue: No ]
  • Natural Log-transformed C-reactive Protein (CRP) [ Time Frame: Change from baseline to last post randomization measurement (52 weeks) ] [ Designated as safety issue: No ]
    Mean change from baseline to the last post randomization measurement in natural log-transformed CRP

  • Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period [ Time Frame: Change from baseline over 52 weeks of treatment ] [ Designated as safety issue: No ]

    The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked:

    • Functional Impairment
    • Magnitude of Task
    • Magnitude of Effort

    At each of the post-randomization visits questions from the TDI were asked related to 3 components:

    Change in

    • Functional Impairment
    • Magnitude of Task
    • Magnitude of Effort

    Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.



Enrollment: 1523
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Roflumilast
500 mcg, once daily, oral administration in the morning
Drug: Roflumilast
500 mcg, once daily, oral administration in the morning
Placebo Comparator: Placebo
once daily
Drug: Placebo
once daily

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • COPD patients having at least one exacerbation within last year
  • FEV1/FVC ratio (post-bronchodilator) ≤ 70%
  • FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

  • COPD exacerbation not resolved at first baseline visit
  • Diagnosis of asthma and/or other relevant lung disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297102

  Show 179 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: P.M. Calverley, Prof. University of Liverpool, UK
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00297102     History of Changes
Other Study ID Numbers: BY217/M2-124
Study First Received: February 27, 2006
Results First Received: March 17, 2011
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Roflumilast
COPD
Chronic obstructive pulmonary disease

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

ClinicalTrials.gov processed this record on April 14, 2014