Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
1 other identifier
interventional
500
7 countries
89
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Nov 2004
Shorter than P25 for phase_3 asthma
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedDecember 2, 2016
September 1, 2016
September 12, 2005
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients with candidiasis of the oropharynx or hoarseness.
Secondary Outcomes (23)
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
- +18 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (89)
Altana Pharma/Nycomed
Brussels, 1000, Belgium
Altana Pharma/Nycomed
Brussels, 1040, Belgium
Altana Pharma/Nycomed
Brussels, 1190, Belgium
Altana Pharma/Nycomed
Halen, 3545, Belgium
Altana Pharma/Nycomed
Jette, 1090, Belgium
Altana Pharma/Nycomed
Maison-Saint-Gérard, 5640, Belgium
Altana Pharma/Nycomed
Namur, 5000, Belgium
Altana Pharma/Nycomed
Ostend, 8400, Belgium
Altana Pharma/Nycomed
Turnhout, 2300, Belgium
Altana Pharma/Nycomed
Veurne, 8630, Belgium
Altana Pharma/Nycomed
Aix-en-Provence, 13090, France
Altana Pharma/Nycomed
Béziers, 34500, France
Altana Pharma/Nycomed
Chauny, 2303, France
Altana Pharma/Nycomed
Grasse, 6130, France
Altana Pharma/Nycomed
La Rochelle, 17000, France
Altana Pharma/Nycomed
Marseille, 13008, France
Altana Pharma/Nycomed
Martigues, 13695, France
Altana Pharma/Nycomed
Metz, 57000, France
Altana Pharma/Nycomed
Montfermeil, 93370, France
Altana Pharma/Nycomed
Montpellier, 34070, France
Altana Pharma/Nycomed
Nice, 6000, France
Altana Pharma/Nycomed
Nîmes, 30900, France
Altana Pharma/Nycomed
Paris, 75014, France
Altana Pharma/Nycomed
Perpignan, 66046, France
Altana Pharma/Nycomed
Vieux-Condé, 59690, France
Altana Pharma/Nycomed
Ancona, 60100, Italy
Altana Pharma/Nycomed
Brescia, 25123, Italy
Altana Pharma/Nycomed
Chieti, 66100, Italy
Altana Pharma/Nycomed
Florence, 50134, Italy
Altana Pharma/Nycomed
Livorno, 57124, Italy
Altana Pharma/Nycomed
Milan, 20122, Italy
Altana Pharma/Nycomed
Milan, 20142, Italy
Altana Pharma/Nycomed
Milazzo (ME), 98057, Italy
Altana Pharma/Nycomed
Napoli, 80131, Italy
Altana Pharma/Nycomed
Pavia, 27100, Italy
Altana Pharma/Nycomed
Pirri-Cagliari, 9134, Italy
Altana Pharma/Nycomed
Pordenone, 33170, Italy
Altana Pharma/Nycomed
Roma, 100, Italy
Altana Pharma/Nycomed
Verona, 30012, Italy
Altana Pharma/Nycomed
Almere Stad, 1315 RA, Netherlands
Altana Pharma/Nycomed
Haarlem, 2012 CE, Netherlands
Altana Pharma/Nycomed
Harderwijk, 3844 DG, Netherlands
Altana Pharma/Nycomed
Heerlen, 6419 PC, Netherlands
Altana Pharma/Nycomed
Helmond, 5707 HA, Netherlands
Altana Pharma/Nycomed
Schiedam, 3116 BA, Netherlands
Altana Pharma/Nycomed
Utrecht, 3584 CX, Netherlands
Altana Pharma/Nycomed
Veldhoven, 5504 DB, Netherlands
Altana Pharma/Nycomed
Almería, 4009, Spain
Altana Pharma/Nycomed
Barcelona, 8222, Spain
Altana Pharma/Nycomed
Córdoba, 14004, Spain
Altana Pharma/Nycomed
Elche, 3203, Spain
Altana Pharma/Nycomed
Guadalajara, 19002, Spain
Altana Pharma/Nycomed
Madrid, 28001, Spain
Altana Pharma/Nycomed
Madrid, 28006, Spain
Altana Pharma/Nycomed
Madrid, 28040, Spain
Altana Pharma/Nycomed
Madrid, 28047, Spain
Altana Pharma/Nycomed
Requena, 46340, Spain
Altana Pharma/Nycomed
San Sebastián, 20014, Spain
Altana Pharma/Nycomed
Valencia, 46014, Spain
Altana Pharma/Nycomed
Valencia, 46017, Spain
Altana Pharma/Nycomed
Basel, 4031, Switzerland
Altana Pharma/Nycomed
Bellinzona, 6500, Switzerland
Altana Pharma/Nycomed
Bern, 3012, Switzerland
Altana Pharma/Nycomed
Bruderholz, 4101, Switzerland
Altana Pharma/Nycomed
La Chauxe-de-Fonds, 2300, Switzerland
Altana Pharma/Nycomed
Lugano, 6900, Switzerland
Altana Pharma/Nycomed
Münchenstein, 4142, Switzerland
Altana Pharma/Nycomed
Münsingen, 3110, Switzerland
Altana Pharma/Nycomed
Münsterlingen, 8596, Switzerland
Altana Pharma/Nycomed
Zurich, 8048, Switzerland
Altana Pharma/Nycomed
Zurich, 8050, Switzerland
Altana Pharma/Nycomed
Zurich, 8063, Switzerland
Altana Pharma/Nycomed
Belfast, BT7 1DA, United Kingdom
Altana Pharma/Nycomed
Belfast, Irland, BT15 3LL, United Kingdom
Altana Pharma/Nycomed
Bradford on Avon, Wiltshire, BA15 1DQ, United Kingdom
Altana Pharma/Nycomed
Chesterfield Derbyshire, S40 4TF, United Kingdom
Altana Pharma/Nycomed
Chippenham, Wiltshire, SN15 2SB, United Kingdom
Altana Pharma/Nycomed
Co. Antrim, BT38 8TP, United Kingdom
Altana Pharma/Nycomed
Downpatrick, Northern Ireland, BT30 6HY, United Kingdom
Altana Pharma/Nycomed
Dronfield, S18 1RU, United Kingdom
Altana Pharma/Nycomed
Glengormley, BT36 4PP, United Kingdom
Altana Pharma/Nycomed
Glengormley Newtownabbey, BT36 5EQ, United Kingdom
Altana Pharma/Nycomed
Hastings, TN34 3EY, United Kingdom
Altana Pharma/Nycomed
Maidenhead, Berks, SI6 2LH, United Kingdom
Altana Pharma/Nycomed
Nottingham, NG3 7DQ, United Kingdom
Altana Pharma/Nycomed
Nottingham, NG5 1PB, United Kingdom
Altana Pharma/Nycomed
Solihull, B91 2JL, United Kingdom
Altana Pharma/Nycomed
Warminster Wiltshire, BA12 9AA, United Kingdom
Altana Pharma/Nycomed
Watford, WD25 0EA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
November 1, 2004
Study Completion
November 1, 2005
Last Updated
December 2, 2016
Record last verified: 2016-09