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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)
Scientific title
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
Secondary ID [1] 0 0
BY217/M2-124
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Timepoint [1] 0 0
Change from baseline over 52 weeks of treatment
Primary outcome [2] 0 0
COPD Exacerbation Rate (Moderate or Severe)
Timepoint [2] 0 0
52 weeks treatment period
Secondary outcome [1] 0 0
Post-bronchodilator FEV1 [L]
Timepoint [1] 0 0
Change from baseline over 52 weeks of treatment
Secondary outcome [2] 0 0
Time to Mortality Due to Any Reason
Timepoint [2] 0 0
52 weeks treatment period
Secondary outcome [3] 0 0
Natural Log-transformed C-reactive Protein (CRP)
Timepoint [3] 0 0
Change from baseline to last post randomization measurement (52 weeks)
Secondary outcome [4] 0 0
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
Timepoint [4] 0 0
Change from baseline over 52 weeks of treatment

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* COPD exacerbation not resolved at first baseline visit
* Diagnosis of asthma and/or other relevant lung disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
1523
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Altana Pharma/Nycomed Investigational Site - Adelaide South Australia
Recruitment hospital [2] 0 0
Altana Pharma/Nycomed Investigational Site - Box Hill
Recruitment hospital [3] 0 0
Altana Pharma/Nycomed Investigational Site - Camperdown
Recruitment hospital [4] 0 0
Altana Pharma/Nycomed Investigational Site - Clayton
Recruitment hospital [5] 0 0
Altana Pharma/Nycomed Investigational Site - Concord
Recruitment hospital [6] 0 0
Altana Pharma/Nycomed Investigational Site - Geelong
Recruitment hospital [7] 0 0
Altana Pharma/Nycomed Investigational Site - Kippa-ring
Recruitment hospital [8] 0 0
Altana Pharma/Nycomed Investigational Site - Nedlands
Recruitment hospital [9] 0 0
Altana Pharma/Nycomed Investigational Site - South Brisbane
Recruitment hospital [10] 0 0
Altana Pharma/Nycomed Investigational Site - Toorak Gardens
Recruitment hospital [11] 0 0
Altana Pharma/Nycomed Investigational Site - Wayville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide South Australia
Recruitment postcode(s) [2] 0 0
VIC 2138 - Box Hill
Recruitment postcode(s) [3] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [4] 0 0
VIC 3168 - Clayton
Recruitment postcode(s) [5] 0 0
2139 - Concord
Recruitment postcode(s) [6] 0 0
VIC 3220 - Geelong
Recruitment postcode(s) [7] 0 0
QLD 4021 - Kippa-ring
Recruitment postcode(s) [8] 0 0
WA 6009 - Nedlands
Recruitment postcode(s) [9] 0 0
QLD 4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
SA 5056 - Toorak Gardens
Recruitment postcode(s) [11] 0 0
SA 5034 - Wayville
Recruitment outside Australia
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United States of America
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California
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New York
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Ohio
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Oregon
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Pennsylvania
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Wisconsin
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Austria
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Feldbach
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Gänserndorf
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Hallein
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Innsbruck
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Linz
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Natters
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Spittal an der Drau
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New Zealand
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Bucharest
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Moscow
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St. Petersburg
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United Kingdom
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Baillieston, Glasgow
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Bangor, Northern Ireland
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Bath, Avon
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Bath
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Belfast
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Birmingham
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Chesterfield
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Co. Antrim
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Cottingham, E York
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County Antrim
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Downpatrick, Northern Ireland
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East Sussex
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Fife
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Glasgow
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Glengormley Newtownabbey
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Harrow
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Kent
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Leamington Spa
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Liverpool
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Nottingham
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Randalstown
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Sheffield
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Solihull
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Southampton
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United Kingdom
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Southdown, Bath
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United Kingdom
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Sunbury on Thames, Middlesex
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Vale of Glamorgan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca AstraZeneca
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Calverley PM, Rabe KF, Goehring UM, Kristiansen S,... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00297102