Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on December 31, 2007
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):
Daniel Dusser, MD, PhD, Principal Investigator, Affiliation: Hospital COCHIN, Paris, France
Summary
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone
propionate on the lung function, symptoms, use of rescue medication, and occurrence of side
effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will
be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily
at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment
period (24 weeks). The study will provide further data on safety and tolerability of
ciclesonide.
Clinical Details
Official title: Comparison of Inhaled Ciclesonide (640 Mcg/Day) and Fluticasone Propionate (1000 Mcg/Day) in Patients With Moderate and Severe Persistent Asthma
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: number of patients with candidiasis of the oropharynx or hoarseness.
Secondary outcome: inhaled Corticosteroids Questionnaire (ICQ)proportion of cases of candidiasis of the oropharynx or hoarseness at each visit Secondary variables FEV1, FVC, PEF from spirometry morning and evening PEF from diaries diurnal PEF fluctuation onset of treatment effect percent days on which patient perceived asthma control percent of nocturnal awakening-free days percent of rescue medication free days percent symptom free days asthma symptom score use of rescue medication time to first asthma exacerbation number of patients with an asthma exacerbation AQLQ number of patients with candidiasis of the oropharynx or hoarseness by severity physical examination, ECG vital sings adverse events standard laboratory work-up morning serum cortisol skin bruising.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Main Inclusion Criteria:
Written informed consent
History of bronchial asthma for at least 6 months
Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent
and a long-acting beta agonist (LABA) either in free or fixed combination
FEV1 ≥ 80% of predicted
Main Exclusion Criteria:
Concomitant severe diseases or diseases which are contraindications for the use of inhaled
steroids or contraindications for the use of LABAs
COPD
Smoking with ≥10 pack-years
Pregnancy
Intention to become pregnant during the course of the study
Breast feeding
Lack of safe contraception
Locations and Contacts
ALTANA Pharma, Cities in Belgium, Belgium
ALTANA Pharma, Cities in France, France
ALTANA Pharma, Cities in Italy, Italy
ALTANA Pharma, Cities in the Netherlands, Netherlands
ALTANA Pharma, Cities in Spain, Spain
ALTANA Pharma, Cities in Switzerland, Switzerland
ALTANA Pharma, Cities in the United Kingdom, United Kingdom
Additional Information
Starting date: November 2004
Last updated: December 15, 2006
|
