Efficacy and safety of roflumilast taken in the morning or evening in patients with stable asthma (12 to 70 y) (BY217/M2-015)

Study identifier:BY217/M2-015

ClinicalTrials.gov identifier:NCT00163475

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

The MOVE-study: Morning versus evening administration of 500 mcg Roflumilast once daily for 6 weeks in patients with asthma

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

Roflumilast

Sex

All

Actual Enrollment

511

Study type

Interventional

Age

12 Years - 70 Years

Date

Study Start Date: 01 May 2004

Primary Completion Date: 01 Aug 2005

Study Completion Date: 01 Aug 2005

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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

No locations available

Arms	Assigned Interventions

Documents available

BY217-M2-015-RDS-2006-06-09
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

AstraZeneca AstraZeneca

AstraZeneca