Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163527




Registration number
NCT00163527
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
2/12/2016

Titles & IDs
Public title
Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
Scientific title
A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma
Secondary ID [1] 0 0
BY217/M2-013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
change in forced expiratory volume in 1 second from baseline to final visit.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
Timepoint [1] 0 0
Secondary outcome [2] 0 0
change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
number of rescue free/symptom free days based on the diary card
Timepoint [3] 0 0
Secondary outcome [4] 0 0
area under the curves over the full 24-week trial period for the diary variables
Timepoint [4] 0 0
Secondary outcome [5] 0 0
number of exacerbations
Timepoint [5] 0 0
Secondary outcome [6] 0 0
time to first exacerbation
Timepoint [6] 0 0
Secondary outcome [7] 0 0
change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
Main

* Written informed consent
* Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
* The patient has been receiving BDP - CFC =1000 mcg per day or equivalent for the previous four weeks
* FEV1 between 60 and 90% predicted at visit 1
* No change in asthma treatment within 4 weeks prior to visit 1

Main
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
* Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
* A history of lower airway infection in the four weeks prior to visit 1
* A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
* Heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
* Patients using >8 puffs/day relief medication regularly prior to visit 1
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
* Patients with chronic heart failure class III or IV (New York Heart Association)
* Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
* A history of alcoholism or substance abuse within the 12 months prior to visit 1
* Pregnancy or women of childbearing potential who are not using a reliable method of contraception

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
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
Austria
State/province [2] 0 0
Cities in Austria
Country [3] 0 0
Croatia
State/province [3] 0 0
Cities in Croatia
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Cities in the Czech Repulik
Country [5] 0 0
Finland
State/province [5] 0 0
Cities in Finland
Country [6] 0 0
France
State/province [6] 0 0
Cities in France
Country [7] 0 0
Greece
State/province [7] 0 0
Cities in Greece
Country [8] 0 0
Hungary
State/province [8] 0 0
Cities in Hungary
Country [9] 0 0
India
State/province [9] 0 0
Cities in India
Country [10] 0 0
Ireland
State/province [10] 0 0
Cities in Ireland
Country [11] 0 0
Italy
State/province [11] 0 0
Cities in Italy
Country [12] 0 0
New Zealand
State/province [12] 0 0
Cities in New Zealand
Country [13] 0 0
Norway
State/province [13] 0 0
Cities in Norway
Country [14] 0 0
Pakistan
State/province [14] 0 0
Cities in Pakistan
Country [15] 0 0
Philippines
State/province [15] 0 0
Cities in the Philippines
Country [16] 0 0
Poland
State/province [16] 0 0
Cities in Poland
Country [17] 0 0
Portugal
State/province [17] 0 0
Cities in Portugal
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Cities in the Russian Federation
Country [19] 0 0
Singapore
State/province [19] 0 0
Sites in Singapore
Country [20] 0 0
South Africa
State/province [20] 0 0
Cities in South Africa
Country [21] 0 0
Spain
State/province [21] 0 0
Cities in Spain
Country [22] 0 0
Taiwan
State/province [22] 0 0
Cities in Taiwan
Country [23] 0 0
Thailand
State/province [23] 0 0
Cities in Thailand
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Cities in the United Kindom

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

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/NCT00163527