AsthmaPhase 3NCT00163462
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 57 sites in 6 countries.
Trial summary
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ciclesonide
- How many people
- 750 participants
- Where
- 57 sitesin 6 countries
- Study dates
- Oct 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Main Inclusion Criteria:
- History of persistent bronchial asthma for at least 6 months
- FEV1 50-90% of predicted
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
- History of life-threatening asthma
- Premature birth
- Current smoking
- Smoking history with either equal or more than 10 pack-years
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
Trial locations and contacts
57 sites in 6 countries.
57 sites in 6 countries
Portugal13 sites
Altana Pharma/Nycomed
Amadora, 2720276
Altana Pharma/Nycomed
Faro, 8000-386
Altana Pharma/Nycomed
Guimarães, 4800055
Altana Pharma/Nycomed
Lisbon, 1269-098
Altana Pharma/Nycomed
Lisbon, 1649035
Altana Pharma/Nycomed
Lisbon, 1990050
Altana Pharma/Nycomed
Matosinhos Municipality, 4450024
Altana Pharma/Nycomed
Oliveira de Azeméis, 3720000
Altana Pharma/Nycomed
Porto, 4099-001
Altana Pharma/Nycomed
Porto, 4200319
Altana Pharma/Nycomed
Setúbal, 2910446
Altana Pharma/Nycomed
Viana do Castelo, 4901858
Altana Pharma/Nycomed
Vila Nova de Gaia, 4400-123
Brazil12 sites
Altana Pharma/Nycomed
Campinas - SP, 13081970
Altana Pharma/Nycomed
Curitiba-PR, 80060900
Altana Pharma/Nycomed
Florianópolis-SC, 88040970
Altana Pharma/Nycomed
Porto Alegre-RS, 90035003
Altana Pharma/Nycomed
Porto Alegre-RS, 90610000
Altana Pharma/Nycomed
Rio de Janeiro-RJ, 21941590
Altana Pharma/Nycomed
Salvador - Bahia, 41920000
Altana Pharma/Nycomed
Santo André-SP, 9060650
Altana Pharma/Nycomed
Sao Paulo - SP, 5437000
Altana Pharma/Nycomed
Sao Paulo-SP, 4025002
Altana Pharma/Nycomed
São Paulo-SP, 1221020
Altana Pharma/Nycomed
São Paulo-SP, 5403900
Hungary9 sites
Altana Pharma/Nycomed
Budapest, 1083
Altana Pharma/Nycomed
Budapest, 1089
Altana Pharma/Nycomed
Budapest, 1121
Altana Pharma/Nycomed
Debrecen, 4012
Altana Pharma/Nycomed
Jászberény, 5100
Altana Pharma/Nycomed
Miskolc, 3501
Altana Pharma/Nycomed
Mosdós, 7257
Altana Pharma/Nycomed
Pécs, 7624
Altana Pharma/Nycomed
Törökbálint, 2045
Germany8 sites
Altana Pharma/Nycomed
Frankfurt, 60590
Altana Pharma/Nycomed
Gaißach Bei Bad Tölz, 83674
Altana Pharma/Nycomed
Geesthacht, 21502
Altana Pharma/Nycomed
Mainz, 55101
Altana Pharma/Nycomed
München, 80337
Altana Pharma/Nycomed
München, 80939
Altana Pharma/Nycomed
Wesel, 46483
Altana Pharma/Nycomed
Wiefelstede, 26215
Poland8 sites
Altana Pharma/Nycomed
Inowrocław, 88-100
Altana Pharma/Nycomed
Lodz, 90-141
Altana Pharma/Nycomed
Lublin, 20-093
Altana Pharma/Nycomed
Poznan, 60-214
Altana Pharma/Nycomed
Rzeszów, 35-301
Altana Pharma/Nycomed
Warsaw, 01-211
Altana Pharma/Nycomed
Warsaw, 03-924
Altana Pharma/Nycomed
Zawadzkie, 46-059
South Africa7 sites
Altana Pharma/Nycomed
Bellville - Cape Town -, 7530
Altana Pharma/Nycomed
Cape Town, 7937
Altana Pharma/Nycomed
Morningside, Sandton, 2196
Altana Pharma/Nycomed
Mowbray, Cape Town, 7925
Altana Pharma/Nycomed
Panorama / RSA-Cape Town, 7500
Altana Pharma/Nycomed
Westville, 3630
Altana Pharma/Nycomed
Wynberg, 7945
About this study
Official title: Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; 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 (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
- Conditions
- Asthma
- Being tested
- Ciclesonide
- Keywords
- Asthma, Ciclesonide, Child, Fluticasone propionate, Pediatric
- 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 absolute values
PD20FEV1 from methacholine challenge.
Secondary outcomes (14)
FEV1 as % of predicted
PEF from spirometry
morning and evening PEF from diary
asthma symptom score from diary
salbutamol MDI use from diary
diurnal PEF fluctuation from diary
dropout rate due to asthma exacerbations and time to the first asthma exacerbation
percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
interview administered PAQLQ(S), self-administered PACQLQ
physical examination and vital signs
laboratory investigation
AEs
HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.
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 startOct 2004
- Primary completionNov 2005
- 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
- 750 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
- NCT00163462
- Sponsor's protocol ID
- BY9010/M1-206
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2005
- Last updated
- 5 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients
- ClinicalTrials.gov ID
- NCT00163462
- Acronym / sponsor ID
- BY9010/M1-206
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide, Child, Fluticasone propionate, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Nov 2005 (actual)
- 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 efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; 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 (12 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
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 absolute values
PD20FEV1 from methacholine challenge.
14 secondary outcomes
FEV1 as % of predicted
PEF from spirometry
morning and evening PEF from diary
asthma symptom score from diary
salbutamol MDI use from diary
diurnal PEF fluctuation from diary
dropout rate due to asthma exacerbations and time to the first asthma exacerbation
percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
interview administered PAQLQ(S), self-administered PACQLQ
physical examination and vital signs
laboratory investigation
AEs
HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.
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 5 Dec 2016.
- BY9010-MI-206-RDS-2006-09-01.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
57 sites in 6 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 57 sites in 6 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 5 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 57 sites in Portugal, Brazil, Hungary, Germany, Poland and 1 more country. 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 absolute values. 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 5 Dec 2016.