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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Roflumilast

• Study Type: Interventional
• Enrollment: 511
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Cities in Australia, Australia
    • ALTANA Pharma
• Belgium
  • Cities in Belgium, Belgium
    • ALTANA Pharma
• France
  • Cities in France, France
    • ALTANA Pharma
• South Africa
  • Cities in South Africa, South Africa
    • ALTANA Pharma
• Spain
  • Cities in Spain, Spain
    • ALTANA Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Asthma Control Questionnaire (ACQ)
forced expiratory vital capacity
peak expiratory flow
morning and evening peak expiratory flow (patient's diary)
symptom score and use of rescue medication (patient's diary)
proportion of symptom-free days / rescue medication-free days asthma exacerbations.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Bateman ED, Bousquet J, Aubier M, Bredenbroker D, O'Byrne PM. Roflumilast for asthma: Efficacy findings in non-placebo-controlled comparator and dosing studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S11-9. doi: 10.1016/j.pupt.2015.10.002. Epub 2015 Oct 8.

Helpful Links

• BY217-M2-015-RDS-2006-06-09

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; Roflumilast
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: BY217/M2-015