Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Ciclesonide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
Jeyaindran Sinnadurai, MD, Study Chair, Affiliation: Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
Reury-Perng Perng, MD, Study Chair, Affiliation: Veterans General Hospital, Taipei, Taiwan
Summary
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.
Clinical Details
Official title: A Comparative Study of Inhaled Ciclesonide 160 Mcg/Day vs Budesonide 400 Mcg/Day in Patients With Asthma
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: FEV1 absolute values.
Secondary outcome: FEV1 as percent of predictedFVC PEF absolute values morning and evening PEF from diary diurnal PEF fluctuation asthma symptom score from diary use of rescue medication from diary number of symptom free- and rescue medication free days dropout rate due to asthma exacerbations time until first asthma exacerbation number of days with asthma control onset of effect subgroup analysis for ex/current smokers and non-smokers AQLQ(S) physical examination vital signs laboratory work-up adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
ALTANA Pharma, Cities in Malaysia, Malaysia
ALTANA Pharma, Cities in Taiwan, Taiwan
Additional Information
Starting date: January 2004
Last updated: December 15, 2006
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