Clinical trial NCT00163319: Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
Official title: Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Fluticasone propionate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: number of patients with candidiasis of the oropharynx or hoarseness.
Secondary outcomes:
measure: inhaled Corticosteroids Questionnaire (ICQ)
measure: proportion of cases of candidiasis of the oropharynx or
measure: hoarseness at each visit Secondary variables
measure: FEV1, FVC, PEF from spirometry
measure: morning and evening PEF from diaries
measure: diurnal PEF fluctuation
measure: onset of treatment effect
measure: percent days on which patient perceived asthma control
measure: percent of nocturnal awakening-free days
measure: percent of rescue medication free days
measure: percent symptom free days
measure: asthma symptom score
measure: use of rescue medication
measure: time to first asthma exacerbation
measure: number of patients with an asthma exacerbation
measure: AQLQ
measure: number of patients with candidiasis of the oropharynx or hoarseness by severity
measure: physical examination, ECG
measure: vital sings
measure: adverse events
measure: standard laboratory work-up
measure: morning serum cortisol
measure: skin bruising.
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Altana Pharma/Nycomed
city: Bruxelles
country: Belgium
facility: Altana Pharma/Nycomed
city: Bruxelles
country: Belgium
facility: Altana Pharma/Nycomed
city: Halen
country: Belgium
facility: Altana Pharma/Nycomed
city: Jette
country: Belgium
facility: Altana Pharma/Nycomed
city: Maison-Saint-Gérard
country: Belgium
facility: Altana Pharma/Nycomed
city: Namur
country: Belgium
facility: Altana Pharma/Nycomed
city: Oostende
country: Belgium
facility: Altana Pharma/Nycomed
city: Turnhout
country: Belgium
facility: Altana Pharma/Nycomed
city: Veurne
country: Belgium
facility: Altana Pharma/Nycomed
city: Aix En Provence
country: France
facility: Altana Pharma/Nycomed
city: Beziers
country: France
facility: Altana Pharma/Nycomed
city: Chauny CEDEX
country: France
facility: Altana Pharma/Nycomed
city: Grasse
country: France
facility: Altana Pharma/Nycomed
city: La Rochelle
country: France
facility: Altana Pharma/Nycomed
city: Marseille
country: France
facility: Altana Pharma/Nycomed
city: Martigues Cedex
country: France
facility: Altana Pharma/Nycomed
city: Metz
country: France
facility: Altana Pharma/Nycomed
city: Montfermeil
country: France
facility: Altana Pharma/Nycomed
city: Montpellier Cedex
country: France
facility: Altana Pharma/Nycomed
city: Nice
country: France
facility: Altana Pharma/Nycomed
city: Nimes
country: France
facility: Altana Pharma/Nycomed
city: Paris
country: France
facility: Altana Pharma/Nycomed
city: Perpignan CEDEX
country: France
facility: Altana Pharma/Nycomed
city: Vieux Conde
country: France
facility: Altana Pharma/Nycomed
city: Ancona
country: Italy
facility: Altana Pharma/Nycomed
city: Brescia
country: Italy
facility: Altana Pharma/Nycomed
city: Chieti
country: Italy
facility: Altana Pharma/Nycomed
city: Firenze
country: Italy
facility: Altana Pharma/Nycomed
city: Livorno
country: Italy
facility: Altana Pharma/Nycomed
city: Milano
country: Italy
facility: Altana Pharma/Nycomed
city: Milano
country: Italy
facility: Altana Pharma/Nycomed
city: Milazzo (ME)
country: Italy
facility: Altana Pharma/Nycomed
city: Napoli
country: Italy
facility: Altana Pharma/Nycomed
city: Pavia
country: Italy
facility: Altana Pharma/Nycomed
city: Pirri-Cagliari
country: Italy
facility: Altana Pharma/Nycomed
city: Pordenone
country: Italy
facility: Altana Pharma/Nycomed
city: Roma
country: Italy
facility: Altana Pharma/Nycomed
city: Verona
country: Italy
facility: Altana Pharma/Nycomed
city: Almere
country: Netherlands
facility: Altana Pharma/Nycomed
city: Haarlem
country: Netherlands
facility: Altana Pharma/Nycomed
city: Harderwijk
country: Netherlands
facility: Altana Pharma/Nycomed
city: Heerlen
country: Netherlands
facility: Altana Pharma/Nycomed
city: Helmond
country: Netherlands
facility: Altana Pharma/Nycomed
city: Schiedam
country: Netherlands
facility: Altana Pharma/Nycomed
city: Utrecht
country: Netherlands
facility: Altana Pharma/Nycomed
city: Veldhoven
country: Netherlands
facility: Altana Pharma/Nycomed
city: Almeria
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Córdoba
country: Spain
facility: Altana Pharma/Nycomed
city: Elche
country: Spain
facility: Altana Pharma/Nycomed
city: Guadalajara
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Requena
country: Spain
facility: Altana Pharma/Nycomed
city: San Sebastián
country: Spain
facility: Altana Pharma/Nycomed
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed
city: Basel
country: Switzerland
facility: Altana Pharma/Nycomed
city: Bellinzona
country: Switzerland
facility: Altana Pharma/Nycomed
city: Bern
country: Switzerland
facility: Altana Pharma/Nycomed
city: Bruderholz
country: Switzerland
facility: Altana Pharma/Nycomed
city: La Chauxe-de-Fonds
country: Switzerland
facility: Altana Pharma/Nycomed
city: Lugano
country: Switzerland
facility: Altana Pharma/Nycomed
city: Münchenstein
country: Switzerland
facility: Altana Pharma/Nycomed
city: Münsingen
country: Switzerland
facility: Altana Pharma/Nycomed
city: Münsterlingen
country: Switzerland
facility: Altana Pharma/Nycomed
city: Zürich
country: Switzerland
facility: Altana Pharma/Nycomed
city: Zürich
country: Switzerland
facility: Altana Pharma/Nycomed
city: Zürich
country: Switzerland
facility: Altana Pharma/Nycomed
city: Belfast, Irland
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Belfast
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Bradford on Avon, Wiltshire
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Chesterfield Derbyshire
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Chippenham, Wiltshire
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Co. Antrim
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Downpatrick, Northern Ireland
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Dronfield
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Glengormley Newtownabbey
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Glengormley
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Hastings
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Maidenhead, Berks
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Nottingham
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Nottingham
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Solihull
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Warminster Wiltshire
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Watford
country: United Kingdom
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: