Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT00163475
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• 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
• Date of first enrolment: May 2004
• Target sample size: 511
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00163475
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, France, South Africa, Spain

Contacts

• Name: AstraZeneca AstraZeneca
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

Main 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

Main 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



Age minimum: 12 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Roflumilast

Primary Outcome(s)

mean change from randomization to endpoint in forced expiratory volume in one second.

Secondary Outcome(s)

morning and evening peak expiratory flow (patient's diary)

Asthma Control Questionnaire (ACQ)

peak expiratory flow

forced expiratory vital capacity

proportion of symptom-free days / rescue medication-free days asthma exacerbations.

symptom score and use of rescue medication (patient's diary)

Secondary ID(s)

BY217/M2-015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors