AsthmaPhase 3NCT00163410
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 16 sites in India.
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. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ciclesonide
- How many people
- 500 participants
- Where
- 16 sitesIndia
- Study dates
- Apr 2003to Dec 2004
- 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 4 to 15 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
16 sites in 1 country.
16 sites in 1 country
India16 sites
Altana Pharma/Nycomed
Ahmedabad, 380 018
Altana Pharma/Nycomed
Bangalore, 560 034
Altana Pharma/Nycomed
Chandigarh, 160 012
Altana Pharma/Nycomed
Coimbatore, 641 004
Altana Pharma/Nycomed
Coimbatore, 641 014
Altana Pharma/Nycomed
Coimbatore, Tamilnadu, 641 044
Altana Pharma/Nycomed
Delhi, 110 007
Altana Pharma/Nycomed
Kolkata, 700091
Altana Pharma/Nycomed
Mumbai, 400 004
Altana Pharma/Nycomed
Mumbai, 400 012
Altana Pharma/Nycomed
Mumbai, 400 022
Altana Pharma/Nycomed
Mumbai, 400 026
Altana Pharma/Nycomed
Pune, 411 001
Altana Pharma/Nycomed
Pune, 411 030
Altana Pharma/Nycomed
Pune, 411 033
Altana Pharma/Nycomed
Shastri Nagar, Jaipur, 302 016
About this study
Official title: A Comparative Study of Inhaled Ciclesonide 200 mcg/Day vs Fluticasone Propionate 200 mcg/Day in Children With Asthma
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 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 (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.
Secondary outcomes (14)
FEV1 as % of predicted
PEF from spirometry
diary based morning and evening PEF
diary based symptom score
diary based salbutamol MDI use
diurnal PEF fluctuation
drop-out rate due to asthma exacerbations
time until asthma exacerbation
number of symptom free- and rescue medication free days
number of days with asthma control
physical examination
vital signs
laboratory work-up
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 startApr 2003
- Primary completionDec 2004
- Study completionDec 2004
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
- NCT00163410
- Sponsor's protocol ID
- BY9010/M1-205
- Status last verified
- Dec 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
- A Comparative Study of Inhaled Ciclesonide 200 mcg/Day vs Fluticasone Propionate 200 mcg/Day in Children With Asthma
- ClinicalTrials.gov ID
- NCT00163410
- Acronym / sponsor ID
- BY9010/M1-205
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide, Child, Fluticasone propionate, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (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 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 (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
- 4 to 15 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.
14 secondary outcomes
FEV1 as % of predicted
PEF from spirometry
diary based morning and evening PEF
diary based symptom score
diary based salbutamol MDI use
diurnal PEF fluctuation
drop-out rate due to asthma exacerbations
time until asthma exacerbation
number of symptom free- and rescue medication free days
number of days with asthma control
physical examination
vital signs
laboratory work-up
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 2 Dec 2016.
- BY9010\_M1-205 SynopsisLink 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
16 sites in 1 country: 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 16 sites in India.
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 16 sites in India. 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.. 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.