AsthmaPhase 3NCT00163423
Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 51 sites in 5 countries.
Trial summary
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ciclesonide
- How many people
- 480 participants
- Where
- 51 sitesin 5 countries
- Study dates
- Nov 2004to Jan 2006
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
- Outpatients
- Written informed consent
- History of bronchial asthma for at least 6 months
- Good health with the exception of asthma
- Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
- FEV1 80 - 105% of predicted
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- Current smoking with more than 10 pack-years
- Previous smoking with more than 10 pack-years
- Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
Trial locations and contacts
51 sites in 5 countries.
51 sites in 5 countries
Canada15 sites
Altana Pharma/Nycomed
Brandon, R7A 5E7
Altana Pharma/Nycomed
Hamilton, L8N 3Z5
Altana Pharma/Nycomed
London, N5W 6A2
Altana Pharma/Nycomed
London, N6C 4Y7
Altana Pharma/Nycomed
Mississauga, L5B 1N1
Altana Pharma/Nycomed
Montreal, H2L 4M1
Altana Pharma/Nycomed
Montreal, H4J1C5
Altana Pharma/Nycomed
Montreal, Quebec, H1V 1X5
Altana Pharma/Nycomed
Ottawa, K1Y 4G2
Altana Pharma/Nycomed
Québec, G8T 7A1
Altana Pharma/Nycomed
Sainte-Foy, Quebec, G1V4G5
Altana Pharma/Nycomed
Sarnia, N7T 4X3
Altana Pharma/Nycomed
Ste-Foy PQ, G1V 4M6
Altana Pharma/Nycomed
Toronto, M4P1P2
Altana Pharma/Nycomed
Woodstock, N4S 4G3
South Africa13 sites
Altana Pharma/Nycomed
Arcadia, Pretoria, 132
Altana Pharma/Nycomed
Bellville, Cape Town, 7530
Altana Pharma/Nycomed
Cape Town, 7764
Altana Pharma/Nycomed
Cape Town, Tygerberg, 7505
Altana Pharma/Nycomed
Durbanville / Cape Town, 7550
Altana Pharma/Nycomed
Gatesville, Cape Town, 7764
Altana Pharma/Nycomed
Lyttleton, 140
Altana Pharma/Nycomed
Mowbray, Cape Town, 7925
Altana Pharma/Nycomed
Observatory Cape, 7925
Altana Pharma/Nycomed
Pretoria, 181
Altana Pharma/Nycomed
Pretoria, 2
Altana Pharma/Nycomed
Westville, 3630
Altana Pharma/Nycomed
Wynberg, 7945
Germany8 sites
Altana Pharma/Nycomed
Geesthacht, 21502
Altana Pharma/Nycomed
Hanover, 30167
Altana Pharma/Nycomed
Heidelberg, 69117
Altana Pharma/Nycomed
Koblenz, 56068
Altana Pharma/Nycomed
Mainz, 55131
Altana Pharma/Nycomed
Marburg, 35037
Altana Pharma/Nycomed
Sinsheim, 74889
Altana Pharma/Nycomed
Witten, 58452
Poland8 sites
Altana Pharma/Nycomed
Bielsko-Biala, 43316
Altana Pharma/Nycomed
Gdansk, 80-847
Altana Pharma/Nycomed
Lodz, 90-141
Altana Pharma/Nycomed
Lubin, 59300
Altana Pharma/Nycomed
Lublin, 20-718
Altana Pharma/Nycomed
Lublin, 20601
Altana Pharma/Nycomed
Wałbrzych, 58300
Altana Pharma/Nycomed
Zgierz, 95100
Austria7 sites
Altana Pharma/Nycomed
Gmünd, 3950
Altana Pharma/Nycomed
Linz, 4020
Altana Pharma/Nycomed
Linz, 4040
Altana Pharma/Nycomed
Neusiedl/See, 7100
Altana Pharma/Nycomed
Perg, 4320
Altana Pharma/Nycomed
Steyr, 4400
Altana Pharma/Nycomed
Wiener Neustadt, 2700
About this study
Official title: Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 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.
FEV1
time to the first asthma exacerbation.
Secondary outcomes (13)
FVC
asthma symptom score
use of rescue medication
AQLQ(S) and EQ-5D
percentage of days on which patients perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
physical examination
vital signs
standard laboratory work-up
adverse events
number of patients with local oropharyngeal adverse events.
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
- Primary completionJan 2006
- Study completionJan 2006
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
- 480 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
- NCT00163423
- Sponsor's protocol ID
- BY9010/M1-142
- Status last verified
- Dec 2016
- First submitted
- 12 Sep 2005
- Last updated
- 8 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT00163423
- Acronym / sponsor ID
- BY9010/M1-142
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide, Fluticasone propionate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (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 efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 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
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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
FEV1
time to the first asthma exacerbation.
13 secondary outcomes
FVC
asthma symptom score
use of rescue medication
AQLQ(S) and EQ-5D
percentage of days on which patients perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
physical examination
vital signs
standard laboratory work-up
adverse events
number of patients with local oropharyngeal adverse events.
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 8 Dec 2016.
- BY9010\_M1-142 Synopsis.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
51 sites in 5 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 51 sites in 5 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 8 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 51 sites in Canada, South Africa, Germany, Poland, Austria. 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?
FEV1. The study lists 2 primary outcomes in all. 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 8 Dec 2016.