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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163475




Registration number
NCT00163475
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
25/10/2016

Titles & IDs
Public title
Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)
Scientific title
The MOVE-study: Morning Versus Evening Administration of 500 mcg Roflumilast Once Daily for 6 Weeks in Patients With Asthma
Secondary ID [1] 0 0
BY217/M2-015
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
mean change from randomization to endpoint in forced expiratory volume in one second.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
forced expiratory vital capacity
Timepoint [1] 0 0
Secondary outcome [2] 0 0
peak expiratory flow
Timepoint [2] 0 0
Secondary outcome [3] 0 0
morning and evening peak expiratory flow (patient's diary)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
symptom score and use of rescue medication (patient's diary)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Asthma Control Questionnaire (ACQ)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
proportion of symptom-free days / rescue medication-free days asthma exacerbations.
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
Main

* Written informed consent
* Diagnosis of persistent bronchial asthma (with reference to the Global Initiative for Asthma Guidelines 2002)
* Baseline FEV1 50 - 85% in patients either untreated or receiving e.g. short-acting bronchodilators, DSCG, nedocromil, anticholinergics, long-acting bronchodilators, theophylline/aminophylline, lipoxygenase inhibitors, leukotriene antagonists, alone or in combination
* Baseline FEV1 60 - 90% in patients receiving not more than 500 mcg BDP-CFC (or equivalent) and/or in combination with any other asthma medication mentioned above
* No change in the asthma treatment 4 weeks prior to baseline period
* Patients who, with the exception of asthma, are in good health

Main
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period
* Patient using regularly >8 puffs/day rescue medication prior to baseline
* History of lower airway infection in the last 4 weeks prior to baseline period
* Diagnosis of chronic obstructive pulmonary disease and/or other relevant lung diseases
* Heavy smoker: currently: >20 cigarettes/day and/or >10 pack years, ex-smoker: with a smoking history of =10 pack years
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Liver insufficiency (Child Pugh A or worse)
* Active hepatitis
* Known infection with HIV
* Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
* Alcohol and/or drug abuse
* Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
* Pregnancy or patient of childbearing potential who is not using reliable method of contraception
* Patients not able to follow study procedures, e.g. due to language problems, psychological disorders
* Suspected inability or unwillingness to comply with the study procedures

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
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2005
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
Belgium
State/province [1] 0 0
Cities in Belgium
Country [2] 0 0
France
State/province [2] 0 0
Cities in France
Country [3] 0 0
South Africa
State/province [3] 0 0
Cities in South Africa
Country [4] 0 0
Spain
State/province [4] 0 0
Cities in Spain

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

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 compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Trial website
https://clinicaltrials.gov/study/NCT00163475
Trial related presentations / publications
Bateman ED, Bousquet J, Aubier M, Bredenbroker D, O'Byrne PM. Roflumilast for asthma: Efficacy findings in non-placebo-controlled comparator and dosing studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S11-9. doi: 10.1016/j.pupt.2015.10.002. Epub 2015 Oct 8.
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/study/NCT00163475