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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00163410 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
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Scientific title:
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A Comparative Study of Inhaled Ciclesonide 200 Mcg/Day vs Fluticasone Propionate 200 Mcg/Day in Children With Asthma |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00163410 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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India
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Contacts
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Name:
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Renate Engelstaetter, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ALTANA Pharma, Konstanz, Germany E-mail: info.clintrials@altanapharma.com |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
- History of persistent bronchial asthma for at least 6 months
- FEV1 50-90% of predicted
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of
inhaled steroids
- COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing
alternating impairment in lung function
- Respiratory tract infection or asthma exacerbation within the last 30 days prior to
entry into the study
- History of life-threatening asthma
- Premature birth
- Current smoking
- Smoking history with either equal or more than 10 pack-years
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
Age minimum:
4 Years
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Ciclesonide
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Primary Outcome(s)
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FEV1 absolute values.
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Secondary Outcome(s)
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adverse events.
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diary based morning and evening PEF
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diary based salbutamol MDI use
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diary based symptom score
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diurnal PEF fluctuation
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drop-out rate due to asthma exacerbations
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FEV1 as % of predicted
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laboratory work-up
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number of days with asthma control
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number of symptom free- and rescue medication free days
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PEF from spirometry
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physical examination
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time until asthma exacerbation
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vital signs
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Secondary ID(s)
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BY9010/M1-205
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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