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

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163475

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Roflumilast	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The MOVE-Study: Morning Versus Evening Administration of 500 Mcg Roflumilast Once Daily for 6 Weeks in Patients With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Roflumilast

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

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.

Estimated Enrollment:	511
Study Start Date:	May 2004
Estimated Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163475

Locations

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

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Chair:	Dirk Bredenbroeker, MD	Altana Pharma, D-78467 Konstanz, Germany
Principal Investigator:	Eric D. Bateman, Prof	UCT Lung Institute

More Information

No publications provided

Study ID Numbers:	BY217/M2-015
Study First Received:	September 12, 2005
Last Updated:	December 15, 2006
ClinicalTrials.gov Identifier:	NCT00163475 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by ALTANA Pharma:

Asthma
Roflumilast

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009