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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/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)
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Scientific title
The MOVE-study: Morning Versus Evening Administration of 500 mcg Roflumilast Once Daily for 6 Weeks in Patients With Asthma
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Secondary ID [1]
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BY217/M2-015
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Roflumilast
Treatment: Drugs: Roflumilast
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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mean change from randomization to endpoint in forced expiratory volume in one second.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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forced expiratory vital capacity
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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peak expiratory flow
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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morning and evening peak expiratory flow (patient's diary)
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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symptom score and use of rescue medication (patient's diary)
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Asthma Control Questionnaire (ACQ)
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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proportion of symptom-free days / rescue medication-free days asthma exacerbations.
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Assessment method [6]
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Timepoint [6]
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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
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Minimum age
12
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2005
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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ALTANA Pharma - Cities in Australia
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Recruitment postcode(s) [1]
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- Cities in Australia
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Cities in Belgium
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Country [2]
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France
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State/province [2]
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Cities in France
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Country [3]
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South Africa
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State/province [3]
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Cities in South Africa
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Country [4]
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Spain
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State/province [4]
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Cities in Spain
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00163475
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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AstraZeneca AstraZeneca
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Address
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AstraZeneca
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00163475
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