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

Asthma Clinical Trial

Official title:

The MOVE-study: Morning Versus Evening Administration of 500 mcg Roflumilast Once Daily for 6 Weeks in Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163475
• Other study ID #: BY217/M2-015
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 24, 2016
• Start date: May 2004
• Est. completion date: August 2005

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Roflumilast

Locations

Country	Name	City	State
Australia	ALTANA Pharma	Cities in Australia
Belgium	ALTANA Pharma	Cities in Belgium
France	ALTANA Pharma	Cities in France
South Africa	ALTANA Pharma	Cities in South Africa
Spain	ALTANA Pharma	Cities in Spain

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Belgium,  France,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change from randomization to endpoint in forced expiratory volume in one second.
Secondary	forced expiratory vital capacity
Secondary	peak expiratory flow
Secondary	morning and evening peak expiratory flow (patient's diary)
Secondary	symptom score and use of rescue medication (patient's diary)
Secondary	Asthma Control Questionnaire (ACQ)
Secondary	proportion of symptom-free days / rescue medication-free days asthma exacerbations.

External Links

•   BY217-M2-015-RDS-2006-06-09