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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00430729




Registration number
NCT00430729
Ethics application status
Date submitted
1/02/2007
Date registered
2/02/2007
Date last updated
30/11/2016

Titles & IDs
Public title
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)
Scientific title
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.
Secondary ID [1] 0 0
BY217/M2-112
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
Timepoint [1] 0 0
Primary outcome [2] 0 0
Change in FEV1 from baseline during the treatment period.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Pulmonary function variables; quality of life variables;patient diary variables;safety
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Main

* FEV1/FVC ratio (post-bronchodilator) =70%
* FEV1 (post-bronchodilator) =50% of predicted
* Current smoker or ex-smoker
* Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
* Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before baseline

Main
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
* Lower respiratory tract infection not resolved 4 weeks prior to baseline
* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Need for long-term oxygen therapy defined as =16 hours/day

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?



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
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ALTANA Pharma - Cities in Australia
Recruitment postcode(s) [1] 0 0
- Cities in Australia
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Cities in Austria
Country [2] 0 0
Canada
State/province [2] 0 0
Cities in Canada
Country [3] 0 0
France
State/province [3] 0 0
Cities in France
Country [4] 0 0
Hungary
State/province [4] 0 0
Cities in Hungary
Country [5] 0 0
Italy
State/province [5] 0 0
Cities in Italy
Country [6] 0 0
Netherlands
State/province [6] 0 0
Cities in the Netherlands
Country [7] 0 0
Poland
State/province [7] 0 0
Cities in Poland
Country [8] 0 0
Portugal
State/province [8] 0 0
Cities in Portugal
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Cities in the Russian Federation
Country [10] 0 0
South Africa
State/province [10] 0 0
Cities in South Africa
Country [11] 0 0
Spain
State/province [11] 0 0
Cities in Spain
Country [12] 0 0
Switzerland
State/province [12] 0 0
Cities in Switzerland
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Cities in the United Kingdom

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00430729