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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Roflumilast

Treatment: Drugs: Roflumilast

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Key inclusion criteria

- 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

Minimum age
12 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
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

- 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
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
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
State/province [1] 0 0
Cities in Belgium
Country [2] 0 0
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
State/province [4] 0 0
Cities in Spain

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
AstraZeneca AstraZeneca
Address 0 0
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
Other publications