AsthmaPhase 3NCT00163449
Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 96 sites in 9 countries.
Trial summary
The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ciclesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 96 sitesin 9 countries
- Study dates
- Nov 2005to May 2007
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Main Inclusion Criteria:
- Written informed consent by the parents or legal guardians of the patient
- Outpatients
- Good health with the exception of asthma
- Documented diagnosis of asthma for more than 6 months
- Use of rescue medication only or pretreatment with a controller drug
Main Exclusion Criteria:
- Concomitant severe diseases
- Diseases contraindicated for the use of inhaled steroids
- Other relevant lung diseases causing impairment in pulmonary function
- Recurrent, episodic wheezing only
- History of life-threatening asthma
- History of any mechanical ventilation
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- Premature birth (< 32 weeks gestation)
Trial locations and contacts
96 sites in 9 countries.
96 sites in 9 countries
Brazil18 sites
Altana Pharma/Nycomed
Campinas - SP, 13081970
Altana Pharma/Nycomed
Curitiba-PR, 80060900
Altana Pharma/Nycomed
Paraná, 80060900
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, 1246-000
Altana Pharma/Nycomed
Porto Alegre-RS, 90035003
Altana Pharma/Nycomed
Porto Alegre-RS, 90610000
Altana Pharma/Nycomed
Recife-PE, 50670901
Altana Pharma/Nycomed
Rio de Janeiro-RJ, 21941590
Altana Pharma/Nycomed
Rio Grande, 90610000
Altana Pharma/Nycomed
Salvador - Bahia, 41920000
Altana Pharma/Nycomed
Santo André-SP, 9060650
Altana Pharma/Nycomed
São Paulo, 1277900
Altana Pharma/Nycomed
São Paulo, 5403900
Altana Pharma/Nycomed
São Paulo, 5651
Altana Pharma/Nycomed
São Paulo
Altana Pharma/Nycomed
Sao Paulo - SP, 5437000
Altana Pharma/Nycomed
Sao Paulo-SP, 4025002
Altana Pharma/Nycomed
São Paulo-SP, 1221020
Hungary16 sites
Altana Pharma/Nycomed
Baja, 6500
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
Kaposvár, 7400
Altana Pharma/Nycomed
Kiskunhalas, 6400
Altana Pharma/Nycomed
Miskolc, 3501
Altana Pharma/Nycomed
Mosdós, 7257
Altana Pharma/Nycomed
Mosonmagyaróvár, 9200
Altana Pharma/Nycomed
Nyíregyháza, 4400
Altana Pharma/Nycomed
Pécs, 7624
Altana Pharma/Nycomed
Szeged, 6720
Altana Pharma/Nycomed
Szekszárd, 7100
Altana Pharma/Nycomed
Törökbálint, 2045
India13 sites
Altana Pharma/Nycomed
Chandanwadi, Thane, 400061
Altana Pharma/Nycomed
Chennai, 600 034
Altana Pharma/Nycomed
Coimbatore, 641 014
Altana Pharma/Nycomed
Coimbatore, 641004
Altana Pharma/Nycomed
Coimbatore, Tamilnadu, 641 044
Altana Pharma/Nycomed
Kalaburagi, 585104
Altana Pharma/Nycomed
Mumbai, 400 004
Altana Pharma/Nycomed
Mumbai, 400008
Altana Pharma/Nycomed
Mumbai, Dadar (E), 400 014
Altana Pharma/Nycomed
Nagpur, 12
Altana Pharma/Nycomed
Noida, 201301
Altana Pharma/Nycomed
Pune, 411 001
Altana Pharma/Nycomed
Pune, 411 033
Spain12 sites
Altana Pharma/Nycomed
Barcelona, 8003
Altana Pharma/Nycomed
Barcelona, 8023
Altana Pharma/Nycomed
Barcelona, 8222
Altana Pharma/Nycomed
El Palmar (Murcia), 30120
Altana Pharma/Nycomed
Elche - Alicante, 3203
Altana Pharma/Nycomed
Leganes (Madrid), 28911
Altana Pharma/Nycomed
Madrid, 28006
Altana Pharma/Nycomed
Madrid, 28009
Altana Pharma/Nycomed
Madrid, 28041
Altana Pharma/Nycomed
Sabadell, 8208
Altana Pharma/Nycomed
Seville, 41071
Altana Pharma/Nycomed
Valencia, 46009
Germany11 sites
Altana Pharma/Nycomed
Berlin, 13353
Altana Pharma/Nycomed
Cologne, 50924
Altana Pharma/Nycomed
Dresden, 1307
Altana Pharma/Nycomed
Düsseldorf, 40225
Altana Pharma/Nycomed
Frankfurt, 60590
Altana Pharma/Nycomed
Heidelberg, 69120
Altana Pharma/Nycomed
Mannheim, 68167
Altana Pharma/Nycomed
München, 80939
Altana Pharma/Nycomed
Rosenheim, 83026
Altana Pharma/Nycomed
Wesel, 46483
Altana Pharma/Nycomed
Wiefelstede, 26215
South Africa11 sites
Altana Pharma/Nycomed
Bellville - Cape Town -, 7530
Altana Pharma/Nycomed
Cape Town, 7937
Altana Pharma/Nycomed
Durban, 3630
Altana Pharma/Nycomed
Morningside, Sandton, 2196
Altana Pharma/Nycomed
Mowbray, Cape Town, 7925
Altana Pharma/Nycomed
New Redruth, Alberton, 1450
Altana Pharma/Nycomed
Overport, Durban, 4091
Altana Pharma/Nycomed
Panorama / RSA-Cape Town, 7500
Altana Pharma/Nycomed
Pietermaritzburg, 3201
Altana Pharma/Nycomed
Westville, 3630
Altana Pharma/Nycomed
Wynberg, 7945
Netherlands6 sites
Altana Pharma/Nycomed
Eindhoven, 5623 EJ
Altana Pharma/Nycomed
Enschede, 7511 JX
Altana Pharma/Nycomed
Hoofddorp, 2134 TM
Altana Pharma/Nycomed
Leeuwarden, 8901 BR
Altana Pharma/Nycomed
Nijmegen, 6532 SZ
Altana Pharma/Nycomed
Zwolle, 8025 AB
Poland6 sites
Altana Pharma/Nycomed
Karpacz, 58-540
Altana Pharma/Nycomed
Lublin, 20-093
Altana Pharma/Nycomed
Opole, 45401
Altana Pharma/Nycomed
Poznan, 60-214
Altana Pharma/Nycomed
Poznan, 60-693
Altana Pharma/Nycomed
Zawadzkie, 46-059
Switzerland3 sites
Altana Pharma/Nycomed
Lausanne, 1011
Altana Pharma/Nycomed
Trimbach, 4632
Altana Pharma/Nycomed
Zurich, 8032
About this study
Official title: BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. 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, Placebo
- Keywords
- Asthma, Ciclesonide, Child, 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
Efficacy and Safety of Ciclesonide
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ciclesonide 40 µg Receives: Drug: Ciclesonide |
| 2 | Active comparator | Ciclesonide 80 µg Receives: Drug: Ciclesonide |
| 3 | Active comparator | Ciclesonide 160 µg Receives: Drug: Ciclesonide |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first moderate or severe asthma exacerbation.
Measured: 24 weeks
Secondary outcomes (18)
rate of patients with moderate or severe asthma exacerbation
Measured: 24 weeks
rate of patients with moderate asthma exacerbation
Measured: 24 weeks
rate of patients with severe asthma exacerbation
Measured: 24 weeks
time to first moderate asthma exacerbation
Measured: 24 weeks
time to first severe asthma exacerbation
Measured: 24 weeks
asthma symptom score from diary
Measured: 24 weeks
use of rescue medication
Measured: 24 weeks
patient perceived asthma control
Measured: 24 weeks
quality of life data (PACQLQ)
Measured: 24 weeks
morning and evening PEF from diary
Measured: 24 weeks
pulmonary function variables measured at the investigational sites
Measured: 24 weeks
adverse events
Measured: 24 weeks
physical examination
Measured: 24 weeks
vital signs
Measured: 24 weeks
laboratory work-up
Measured: 24 weeks
serum cortisol
Measured: 24 weeks
urine cortisol variables
Measured: 24 weeks
body growth determined by stadiometry.
Measured: 24 weeks
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 2005
- Primary completionNov 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 participants (estimated)
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
- NCT00163449
- Sponsor's protocol ID
- BY9010/M1-207
- Status last verified
- Dec 2016
- First submitted
- 12 Sep 2005
- Last updated
- 8 Dec 2016
- Results posted
- No
Publications
Brand PL, Luz Garcia-Garcia M, Morison A, Vermeulen JH, Weber HC. Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy. Respir Med. 2011 Nov;105(11):1588-95. doi: 10.1016/j.rmed.2011.07.017. Epub 2011 Aug 11.
PubMed 21839625
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
- BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
- ClinicalTrials.gov ID
- NCT00163449
- Acronym / sponsor ID
- BY9010/M1-207
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide, Child, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- May 2007 (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 present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CiclesonideCiclesonide 40 µg |
| 2 | Active comparator | Drug: CiclesonideCiclesonide 80 µg |
| 3 | Active comparator | Drug: CiclesonideCiclesonide 160 µg |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 2 to 6 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 |
|---|---|---|
| CiclesonideEfficacy and Safety of Ciclesonide | Drug | 1, 2, 3 |
| PlaceboPlacebo | Drug | 4 |
Primary outcome
time to first moderate or severe asthma exacerbation.
Time frame: 24 weeks
18 secondary outcomes
rate of patients with moderate or severe asthma exacerbation
Time frame: 24 weeks
rate of patients with moderate asthma exacerbation
Time frame: 24 weeks
rate of patients with severe asthma exacerbation
Time frame: 24 weeks
time to first moderate asthma exacerbation
Time frame: 24 weeks
time to first severe asthma exacerbation
Time frame: 24 weeks
asthma symptom score from diary
Time frame: 24 weeks
use of rescue medication
Time frame: 24 weeks
patient perceived asthma control
Time frame: 24 weeks
quality of life data (PACQLQ)
Time frame: 24 weeks
morning and evening PEF from diary
Time frame: 24 weeks
pulmonary function variables measured at the investigational sites
Time frame: 24 weeks
adverse events
Time frame: 24 weeks
physical examination
Time frame: 24 weeks
vital signs
Time frame: 24 weeks
laboratory work-up
Time frame: 24 weeks
serum cortisol
Time frame: 24 weeks
urine cortisol variables
Time frame: 24 weeks
body growth determined by stadiometry.
Time frame: 24 weeks
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.
- Derived from this study: PubMed 21839625Brand PL, Luz Garcia-Garcia M, Morison A, Vermeulen JH, Weber HC. Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy. Respir Med. 2011 Nov;105(11):1588-95. doi: 10.1016/j.rmed.2011.07.017. Epub 2011 Aug 11.
- BY9010-M1-207-DEU RDS-2008-03-20.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
96 sites in 9 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 96 sites in 9 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 96 sites in Brazil, Hungary, India, Spain, Germany and 4 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. Some participants in this study may receive a placebo. 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?
time to first moderate or severe asthma exacerbation. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00163449, which also lists 1 linked publication.
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.