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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/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
Treatment: Drugs - Roflumilast

Treatment: Drugs: Roflumilast
Intervention code [1] 0 0
Treatment: Drugs
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
The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on
exacerbation rate and pulmonary function as well as quality of life in patients with chronic
obstructive pulmonary disease (COPD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00430729
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00430729