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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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VIC 3220 - Geelong
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QLD 4021 - Kippa-ring
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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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Belfast
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Sunbury on Thames, Middlesex
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Vale of Glamorgan

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

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00297102
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