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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/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
Treatment: Drugs - Roflumilast

Treatment: Drugs: Roflumilast
Intervention code [1] 0 0
Treatment: Drugs
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
Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally
active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown
effectiveness in the treatment of asthma.

The aim of the study is to investigate the effect of roflumilast taken orally together with
low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one
dose level once daily together with inhaled corticosteroids at one dose level twice daily.
The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24
weeks). The study will provide further data on safety, tolerability, and effectiveness of
roflumilast.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163527
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/NCT00163527