- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163397
Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
November 29, 2016 updated by: AstraZeneca
A Comparative Study of Inhaled Ciclesonide 160 mcg/Day vs Budesonide 400 mcg/Day in Patients With Asthma
The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma.
Ciclesonide and budesonide will be inhaled once daily at one dose level each.
The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 weeks).
The study will provide further data on safety and tolerability of ciclesonide.
Study Overview
Study Type
Interventional
Enrollment
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kota Bharu / Kelantan, Malaysia, 16150
- Altana Pharma/Nycomed
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Kuala Lumpur, Malaysia, 50603
- Altana Pharma/Nycomed
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Kuala Lumpur, Malaysia, 56000
- Altana Pharma/Nycomed
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Kuala Lumpur, Malaysia, 50586
- Altana Pharma/Nycomed
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Taipei, Taiwan
- Altana Pharma/Nycomed
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Taipei City 114, Taiwan, 886-114
- Altana Pharma/Nycomed
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
- FEV1 80 - 105% of predicted
- Healthy with the exception of asthma
- Written informed consent has been obtained
- Outpatients
- Patients who have a history of persistent bronchial asthma for at least 6 months
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
- Patient is current smoker with 10 or more pack-years
- Patient is ex-smoker with 10 or more pack-years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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FEV1 absolute values.
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Secondary Outcome Measures
Outcome Measure |
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physical examination
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FVC
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vital signs
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morning and evening PEF from diary
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asthma symptom score from diary
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diurnal PEF fluctuation
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number of symptom free- and rescue medication free days
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number of days with asthma control
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laboratory work-up
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adverse events.
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AQLQ(S)
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FEV1 as percent of predicted
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PEF absolute values
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use of rescue medication from diary
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dropout rate due to asthma exacerbations
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time until first asthma exacerbation
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onset of effect
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subgroup analysis for ex/current smokers and non-smokers
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
November 30, 2016
Last Update Submitted That Met QC Criteria
November 29, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Allergic Agents
- Ciclesonide
Other Study ID Numbers
- BY9010/M1-137
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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