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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00297102
Registration number
NCT00297102
Ethics application status
Date submitted
27/02/2006
Date registered
28/02/2006
Date last updated
16/01/2017
Titles & IDs
Public title
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
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Scientific title
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
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Secondary ID [1]
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BY217/M2-124
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD)
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Condition category
Condition code
Respiratory
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Roflumilast
Treatment: Drugs - Placebo
Active comparator: Roflumilast - 500 mcg, once daily, oral administration in the morning
Placebo comparator: Placebo - once daily
Treatment: Drugs: Roflumilast
500 mcg, once daily, oral administration in the morning
Treatment: Drugs: Placebo
once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
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Assessment method [1]
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Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
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Timepoint [1]
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Change from baseline over 52 weeks of treatment
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Primary outcome [2]
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COPD Exacerbation Rate (Moderate or Severe)
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Assessment method [2]
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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 \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
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Timepoint [2]
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52 weeks treatment period
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Secondary outcome [1]
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Post-bronchodilator FEV1 [L]
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Assessment method [1]
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Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
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Timepoint [1]
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Change from baseline over 52 weeks of treatment
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Secondary outcome [2]
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Time to Mortality Due to Any Reason
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Assessment method [2]
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Timepoint [2]
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52 weeks treatment period
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Secondary outcome [3]
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Natural Log-transformed C-reactive Protein (CRP)
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Assessment method [3]
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Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
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Timepoint [3]
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Change from baseline to last post randomization measurement (52 weeks)
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Secondary outcome [4]
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Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
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Assessment method [4]
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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.
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Timepoint [4]
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Change from baseline over 52 weeks of treatment
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Eligibility
Key inclusion criteria
Main
* COPD patients having at least one exacerbation within last year
* FEV1/FVC ratio (post-bronchodilator) = 70%
* FEV1 (post-bronchodilator) = 50% of predicted
Main
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* COPD exacerbation not resolved at first baseline visit
* Diagnosis of asthma and/or other relevant lung disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2008
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Sample size
Target
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Accrual to date
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Final
1523
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Altana Pharma/Nycomed Investigational Site - Adelaide South Australia
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Recruitment hospital [2]
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Altana Pharma/Nycomed Investigational Site - Box Hill
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Altana Pharma/Nycomed Investigational Site - Camperdown
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Altana Pharma/Nycomed Investigational Site - Clayton
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Altana Pharma/Nycomed Investigational Site - Kippa-ring
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Altana Pharma/Nycomed Investigational Site - Toorak Gardens
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Recruitment hospital [11]
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Altana Pharma/Nycomed Investigational Site - Wayville
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5000 - Adelaide South Australia
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VIC 2138 - Box Hill
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NSW 2050 - Camperdown
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VIC 3168 - Clayton
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2139 - Concord
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VIC 3220 - Geelong
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QLD 4021 - Kippa-ring
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WA 6009 - Nedlands
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QLD 4101 - South Brisbane
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SA 5056 - Toorak Gardens
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SA 5034 - Wayville
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Recruitment outside Australia
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Vale of Glamorgan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT00297102
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Trial related presentations / publications
Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1. Erratum In: Lancet. 2010 Oct 2;376(9747):1146. Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17. Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30. Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489. Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.
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Contacts
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AstraZeneca AstraZeneca
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AstraZeneca
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
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Journal
Calverley PM, Rabe KF, Goehring UM, Kristiansen S,...
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Results are available at
https://clinicaltrials.gov/study/NCT00297102
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