AsthmaPhase 3NCT00163436
Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 66 sites in 6 countries.
Trial summary
The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks). 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
- 450 participants
- Where
- 66 sitesin 6 countries
- Study dates
- Sep 2005to 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:
- Written informed consent
- History of persistent bronchial asthma for at least 6 months
- Good health with the exception of asthma
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- Smoking history with ≥10 cigarette pack years
- Pregnancy
- Intention to become pregnant
- Breast feeding
- Lack of safe contraception
- Previous enrolment into the current study
Trial locations and contacts
66 sites in 6 countries.
66 sites in 6 countries
Canada15 sites
Altana Pharma/Nycomed
La Malbaie, Quebec, G5A 1W7
Altana Pharma/Nycomed
London, N6A 5R9
Altana Pharma/Nycomed
London,ON, N6A1V2
Altana Pharma/Nycomed
Mississauga, L5B 1N1
Altana Pharma/Nycomed
Montreal, Quebec, H1V 1X5
Altana Pharma/Nycomed
Québec, G8T 7A1
Altana Pharma/Nycomed
Richmond Hill, L4S 1P3
Altana Pharma/Nycomed
Sainte-Foy, Quebec, G1V4G5
Altana Pharma/Nycomed
Saskatoon,SK, S7H 0W2
Altana Pharma/Nycomed
Scarborough,ON, M1B 4Z8
Altana Pharma/Nycomed
Toronto, M4P1P2
Altana Pharma/Nycomed
Vancouver, BC, V5Z 4E1
Altana Pharma/Nycomed
Winnipeg, R2M 5L9
Altana Pharma/Nycomed
Winnipeg MB, R3C 0N2
Altana Pharma/Nycomed
Woodstock, N4S 4G3
France15 sites
Altana Pharma/Nycomed
Aix-en-Provence, 13090
Altana Pharma/Nycomed
Chauny, 2303
Altana Pharma/Nycomed
Ferolles-Attily, 77150
Altana Pharma/Nycomed
Grasse, 6130
Altana Pharma/Nycomed
La Rochelle, 17000
Altana Pharma/Nycomed
La Teste-de-Buch, 33260
Altana Pharma/Nycomed
Libourne, 33500
Altana Pharma/Nycomed
Lille, 59000
Altana Pharma/Nycomed
Martigues, 13695
Altana Pharma/Nycomed
Montbrison, 42600
Altana Pharma/Nycomed
Montpellier, 34070
Altana Pharma/Nycomed
Nice, 6000
Altana Pharma/Nycomed
Nîmes, 30900
Altana Pharma/Nycomed
Saint-Laurent-du-Var, 6700
Altana Pharma/Nycomed
Saint-Quentin, 2100
Hungary13 sites
Altana Pharma/Nycomed
Balassagyarmat, 2660
Altana Pharma/Nycomed
Budapest, 1121
Altana Pharma/Nycomed
Budapest, 1134
Altana Pharma/Nycomed
Budapet, 1529
Altana Pharma/Nycomed
Érd, 2030
Altana Pharma/Nycomed
Gyula, 5703
Altana Pharma/Nycomed
Komárom, 2900
Altana Pharma/Nycomed
Miskolc, 3501
Altana Pharma/Nycomed
Mosdós, 7257
Altana Pharma/Nycomed
Nyiregyháza, 4412
Altana Pharma/Nycomed
Pécs, 7621
Altana Pharma/Nycomed
Szeged, 6722
Altana Pharma/Nycomed
Székesfehérvár, 8000
India10 sites
Altana Pharma/Nycomed
Bangalore, 560 034
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
Goa, 403 002
Altana Pharma/Nycomed
Kalaburagi, 585105
Altana Pharma/Nycomed
Mumbai, 400008
Altana Pharma/Nycomed
Mumbai, Dadar (E), 400 014
Altana Pharma/Nycomed
Pune
Italy7 sites
Altana Pharma/Nycomed
Florence, 50134
Altana Pharma/Nycomed
Milan, 20122
Altana Pharma/Nycomed
Milan, 20142
Altana Pharma/Nycomed
Milan, 20153
Altana Pharma/Nycomed
Naples, 80131
Altana Pharma/Nycomed
Pordenone, 33170
Altana Pharma/Nycomed
Verona, 30012
Germany6 sites
Altana Pharma/Nycomed
Berlin, 10717
Altana Pharma/Nycomed
Berlin, 13597
Altana Pharma/Nycomed
Oschersleben, 39387
Altana Pharma/Nycomed
Rüdersdorf, 15562
Altana Pharma/Nycomed
Schwetzingen, 68723
Altana Pharma/Nycomed
Weinheim, 69469
About this study
Official title: Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma
The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).
- Conditions
- Asthma
- Being tested
- Ciclesonide
- Keywords
- Asthma, Ciclesonide
- 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.
Secondary outcomes (15)
FVC
morning and evening PEF from diaries
asthma symptom score
use of rescue medication
number of patients with an asthma exacerbation
time to the first asthma exacerbation
percentage of days on which patient perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
adverse events
physical examination
vital signs
standard laboratory work-up
8 am serum cortisol.
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 startSep 2005
- 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
- None (open label)
- Enrolment
- 450 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
- NCT00163436
- Sponsor's protocol ID
- BY9010/M1-145
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2005
- Last updated
- 30 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma
- ClinicalTrials.gov ID
- NCT00163436
- Acronym / sponsor ID
- BY9010/M1-145
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- 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 present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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.
15 secondary outcomes
FVC
morning and evening PEF from diaries
asthma symptom score
use of rescue medication
number of patients with an asthma exacerbation
time to the first asthma exacerbation
percentage of days on which patient perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
adverse events
physical examination
vital signs
standard laboratory work-up
8 am serum cortisol.
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 30 Nov 2016.
- BY9010-MI-145-RDS-2007-05-21.pdfLink provided by the sponsor.
Related trials for Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
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
66 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 66 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 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Canada, France, Hungary, India, Italy 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.. 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 30 Nov 2016; AzTrials last refreshed its copy on 6 Nov 2026.