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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163475
First Posted: September 14, 2005
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double
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 AstraZeneca:

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
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163475     History of Changes
Other Study ID Numbers: BY217/M2-015
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: October 25, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
Asthma
Roflumilast

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