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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Roflumilast

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Asthma Control Questionnaire (ACQ)
proportion of symptom-free days / rescue medication-free days asthma exacerbations.

Full Information

First Posted
September 12, 2005
Last Updated
October 24, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00163475
Brief Title
Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)
Official Title
The MOVE-study: Morning Versus Evening Administration of 500 mcg Roflumilast Once Daily for 6 Weeks in Patients With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Roflumilast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
511 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Roflumilast
Primary Outcome Measure Information:
Title
mean change from randomization to endpoint in forced expiratory volume in one second.
Secondary Outcome Measure Information:
Title
forced expiratory vital capacity
Title
peak expiratory flow
Title
morning and evening peak expiratory flow (patient's diary)
Title
symptom score and use of rescue medication (patient's diary)
Title
Asthma Control Questionnaire (ACQ)
Title
proportion of symptom-free days / rescue medication-free days asthma exacerbations.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
ALTANA Pharma
City
Cities in Australia
Country
Australia
Facility Name
ALTANA Pharma
City
Cities in Belgium
Country
Belgium
Facility Name
ALTANA Pharma
City
Cities in France
Country
France
Facility Name
ALTANA Pharma
City
Cities in South Africa
Country
South Africa
Facility Name
ALTANA Pharma
City
Cities in Spain
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26456372
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4473&filename=BY217-M2-015-RDS-2006-06-09.pdf
Description
BY217-M2-015-RDS-2006-06-09

Learn more about this trial

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

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