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Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

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. Identifier: NCT00163527
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):

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 investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Condition or disease Intervention/treatment Phase
Asthma Drug: Roflumilast Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2054 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma
Study Start Date : April 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Roflumilast

Primary Outcome Measures :
  1. change in forced expiratory volume in 1 second from baseline to final visit.

Secondary Outcome Measures :
  1. change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
  2. change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
  3. number of rescue free/symptom free days based on the diary card
  4. area under the curves over the full 24-week trial period for the diary variables
  5. number of exacerbations
  6. time to first exacerbation
  7. change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).

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.

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • Written informed consent
  • Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
  • The patient has been receiving BDP - CFC ≤1000 mcg per day or equivalent for the previous four weeks
  • FEV1 between 60 and 90% predicted at visit 1
  • No change in asthma treatment within 4 weeks prior to visit 1

Main Exclusion Criteria:

  • Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
  • Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
  • A history of lower airway infection in the four weeks prior to visit 1
  • A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
  • Heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
  • Patients using >8 puffs/day relief medication regularly prior to visit 1
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
  • A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
  • Patients with chronic heart failure class III or IV (New York Heart Association)
  • Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
  • A history of alcoholism or substance abuse within the 12 months prior to visit 1
  • Pregnancy or women of childbearing potential who are not using a reliable method of contraception

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 identifier (NCT number): NCT00163527

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Sponsors and Collaborators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT00163527     History of Changes
Other Study ID Numbers: BY217/M2-013
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: September 2016
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases