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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163475
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: December 2006
  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 3

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


Further study details as provided by Takeda:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Takeda
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

ClinicalTrials.gov Identifier: NCT00163475     History of Changes
Other Study ID Numbers: BY217/M2-015
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Takeda:
Asthma
Roflumilast

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014