AsthmaPhase 3NCT00163319
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 89 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ciclesonide
- How many people
- 500 participants
- Where
- 89 sitesin 7 countries
- Study dates
- Nov 2004to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
89 sites in 7 countries.
89 sites in 7 countries
United Kingdom17 sites
Altana Pharma/Nycomed
Belfast, BT7 1DA
Altana Pharma/Nycomed
Belfast, Irland, BT15 3LL
Altana Pharma/Nycomed
Bradford on Avon, Wiltshire, BA15 1DQ
Altana Pharma/Nycomed
Chesterfield Derbyshire, S40 4TF
Altana Pharma/Nycomed
Chippenham, Wiltshire, SN15 2SB
Altana Pharma/Nycomed
Co. Antrim, BT38 8TP
Altana Pharma/Nycomed
Downpatrick, Northern Ireland, BT30 6HY
Altana Pharma/Nycomed
Dronfield, S18 1RU
Altana Pharma/Nycomed
Glengormley, BT36 4PP
Altana Pharma/Nycomed
Glengormley Newtownabbey, BT36 5EQ
Altana Pharma/Nycomed
Hastings, TN34 3EY
Altana Pharma/Nycomed
Maidenhead, Berks, SI6 2LH
Altana Pharma/Nycomed
Nottingham, NG3 7DQ
Altana Pharma/Nycomed
Nottingham, NG5 1PB
Altana Pharma/Nycomed
Solihull, B91 2JL
Altana Pharma/Nycomed
Warminster Wiltshire, BA12 9AA
Altana Pharma/Nycomed
Watford, WD25 0EA
France15 sites
Altana Pharma/Nycomed
Aix-en-Provence, 13090
Altana Pharma/Nycomed
Béziers, 34500
Altana Pharma/Nycomed
Chauny, 2303
Altana Pharma/Nycomed
Grasse, 6130
Altana Pharma/Nycomed
La Rochelle, 17000
Altana Pharma/Nycomed
Marseille, 13008
Altana Pharma/Nycomed
Martigues, 13695
Altana Pharma/Nycomed
Metz, 57000
Altana Pharma/Nycomed
Montfermeil, 93370
Altana Pharma/Nycomed
Montpellier, 34070
Altana Pharma/Nycomed
Nice, 6000
Altana Pharma/Nycomed
Nîmes, 30900
Altana Pharma/Nycomed
Paris, 75014
Altana Pharma/Nycomed
Perpignan, 66046
Altana Pharma/Nycomed
Vieux-Condé, 59690
Italy14 sites
Altana Pharma/Nycomed
Ancona, 60100
Altana Pharma/Nycomed
Brescia, 25123
Altana Pharma/Nycomed
Chieti, 66100
Altana Pharma/Nycomed
Florence, 50134
Altana Pharma/Nycomed
Livorno, 57124
Altana Pharma/Nycomed
Milan, 20122
Altana Pharma/Nycomed
Milan, 20142
Altana Pharma/Nycomed
Milazzo (ME), 98057
Altana Pharma/Nycomed
Naples, 80131
Altana Pharma/Nycomed
Pavia, 27100
Altana Pharma/Nycomed
Pirri-Cagliari, 9134
Altana Pharma/Nycomed
Pordenone, 33170
Altana Pharma/Nycomed
Roma, 100
Altana Pharma/Nycomed
Verona, 30012
Spain13 sites
Altana Pharma/Nycomed
Almería, 4009
Altana Pharma/Nycomed
Barcelona, 8222
Altana Pharma/Nycomed
Córdoba, 14004
Altana Pharma/Nycomed
Elche, 3203
Altana Pharma/Nycomed
Guadalajara, 19002
Altana Pharma/Nycomed
Madrid, 28001
Altana Pharma/Nycomed
Madrid, 28006
Altana Pharma/Nycomed
Madrid, 28040
Altana Pharma/Nycomed
Madrid, 28047
Altana Pharma/Nycomed
Requena, 46340
Altana Pharma/Nycomed
San Sebastián, 20014
Altana Pharma/Nycomed
Valencia, 46014
Altana Pharma/Nycomed
Valencia, 46017
Switzerland12 sites
Altana Pharma/Nycomed
Basel, 4031
Altana Pharma/Nycomed
Bellinzona, 6500
Altana Pharma/Nycomed
Bern, 3012
Altana Pharma/Nycomed
Bruderholz, 4101
Altana Pharma/Nycomed
La Chauxe-de-Fonds, 2300
Altana Pharma/Nycomed
Lugano, 6900
Altana Pharma/Nycomed
Münchenstein, 4142
Altana Pharma/Nycomed
Münsingen, 3110
Altana Pharma/Nycomed
Münsterlingen, 8596
Altana Pharma/Nycomed
Zurich, 8048
Altana Pharma/Nycomed
Zurich, 8050
Altana Pharma/Nycomed
Zurich, 8063
Belgium10 sites
Altana Pharma/Nycomed
Brussels, 1000
Altana Pharma/Nycomed
Brussels, 1040
Altana Pharma/Nycomed
Brussels, 1190
Altana Pharma/Nycomed
Halen, 3545
Altana Pharma/Nycomed
Jette, 1090
Altana Pharma/Nycomed
Maison-Saint-Gérard, 5640
Altana Pharma/Nycomed
Namur, 5000
Altana Pharma/Nycomed
Ostend, 8400
Altana Pharma/Nycomed
Turnhout, 2300
Altana Pharma/Nycomed
Veurne, 8630
Netherlands8 sites
Altana Pharma/Nycomed
Almere Stad, 1315 RA
Altana Pharma/Nycomed
Haarlem, 2012 CE
Altana Pharma/Nycomed
Harderwijk, 3844 DG
Altana Pharma/Nycomed
Heerlen, 6419 PC
Altana Pharma/Nycomed
Helmond, 5707 HA
Altana Pharma/Nycomed
Schiedam, 3116 BA
Altana Pharma/Nycomed
Utrecht, 3584 CX
Altana Pharma/Nycomed
Veldhoven, 5504 DB
About this study
Official title: Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
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.
- Conditions
- Asthma
- Being tested
- Ciclesonide
- Keywords
- Asthma, Ciclesonide, Fluticasone propionate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclesonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startNov 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163319
- Sponsor's protocol ID
- BY9010/IT-101
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2005
- Last updated
- 2 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
- ClinicalTrials.gov ID
- NCT00163319
- Acronym / sponsor ID
- BY9010/IT-101
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide, Fluticasone propionate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciclesonide | Drug | – |
Primary outcome
number of patients with candidiasis of the oropharynx or hoarseness.
23 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- BY9010-IT-101-RDS-2006-09-21.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca AstraZeneca study director
AstraZeneca
89 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 89 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United Kingdom, France, Italy, Spain, Switzerland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with candidiasis of the oropharynx or hoarseness.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.