AsthmaPhase 3NCT00163358
Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 111 sites in 7 countries.
Trial summary
The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). 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
- 630 participants
- Where
- 111 sitesin 7 countries
- Study dates
- Sep 2003to Oct 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
- Clinical diagnosis of mild persistent asthma
- Pre-treatment with SABAs only
- FEV1 ≥80% predicted
- Good health with the exception of asthma
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 pulmonary function
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
- Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
Trial locations and contacts
111 sites in 7 countries.
111 sites in 7 countries
Canada27 sites
Altana Pharma/Nycomed
Beaconsfield, QC, H9W2X3
Altana Pharma/Nycomed
Coquitlam, V3K 3P4
Altana Pharma/Nycomed
Coquitlam, BC, V3K 3V9
Altana Pharma/Nycomed
Corner Brook, NFLD
Altana Pharma/Nycomed
Cowansville, J2K2X9
Altana Pharma/Nycomed
Kingston, Ontario, K7L 2V6
Altana Pharma/Nycomed
Langley BC, V3A 4H9
Altana Pharma/Nycomed
Laval, H7V3Y7
Altana Pharma/Nycomed
Les Saules, QC, G1P 1J6
Altana Pharma/Nycomed
Longueuil, PQ, J4N 1E1
Altana Pharma/Nycomed
Montreal, H4J1C5
Altana Pharma/Nycomed
Montreal, PQ, H3H 1V4
Altana Pharma/Nycomed
North Bay, P1B2H3
Altana Pharma/Nycomed
North York, M3H 3S3
Altana Pharma/Nycomed
Ottawa, K1Y 4G2
Altana Pharma/Nycomed
Penticton, BC, V2A 5C8
Altana Pharma/Nycomed
Québec, G8T 7A1
Altana Pharma/Nycomed
Saint John, E2K2T8
Altana Pharma/Nycomed
Sainte-Foy, Quebec, G1V4G5
Altana Pharma/Nycomed
Saskatoon, SK, S7K 3H3
Altana Pharma/Nycomed
St. John's, A1A 3R5
Altana Pharma/Nycomed
St. John's, A1E 2C2
Altana Pharma/Nycomed
Ste-Foy PQ, G1V 4M6
Altana Pharma/Nycomed
Toronto, M4N3N5
Altana Pharma/Nycomed
Toronto, M4P1P2
Altana Pharma/Nycomed
Toronto, M9W 4L6
Altana Pharma/Nycomed
Toronto on, M5S 2A5
Czechia21 sites
Altana Pharma/Nycomed
Beroun, 266 01
Altana Pharma/Nycomed
Česká Lípa, 470 01
Altana Pharma/Nycomed
Cvikov, 471 54
Altana Pharma/Nycomed
Havlickuv, 580 01
Altana Pharma/Nycomed
Jihlava, 58601
Altana Pharma/Nycomed
Jindřichův Hradec, 377 01
Altana Pharma/Nycomed
Karlovy Vary, 360 00
Altana Pharma/Nycomed
Kladno, 272 01
Altana Pharma/Nycomed
Kutná Hora, 28401
Altana Pharma/Nycomed
Ostrava-Marián.Hory, 70030
Altana Pharma/Nycomed
Prague, 100 00
Altana Pharma/Nycomed
Prague, 128 00
Altana Pharma/Nycomed
Prague, 14046
Altana Pharma/Nycomed
Prague, 181 00
Altana Pharma/Nycomed
Prague, 190 61
Altana Pharma/Nycomed
Pribram VI, 261 05
Altana Pharma/Nycomed
Príbram VIII, 261 01
Altana Pharma/Nycomed
Rokycany, 337 01
Altana Pharma/Nycomed
Strakonice, 38601
Altana Pharma/Nycomed
Trutnov, 54101
Altana Pharma/Nycomed
Ústí nad Labem, 401 13
Australia16 sites
Altana Pharma/Nycomed
Adelaide South Australia, 5000
Altana Pharma/Nycomed
Auchenflower, QLD 4066
Altana Pharma/Nycomed
Bracken Ridge, QLD 4017
Altana Pharma/Nycomed
Burwood, NSW 2134
Altana Pharma/Nycomed
Camperdown, NSW 2050
Altana Pharma/Nycomed
Carina Heights, QLD 4152
Altana Pharma/Nycomed
Clayton, VIC 3168
Altana Pharma/Nycomed
Concord, 2139
Altana Pharma/Nycomed
Geelong, VIC 3220
Altana Pharma/Nycomed
Inala, QLD 4077
Altana Pharma/Nycomed
Kippa-Ring, QLD 4021
Altana Pharma/Nycomed
Nedlands, WA 6009
Altana Pharma/Nycomed
Rosebud, VIC 3939
Altana Pharma/Nycomed
South Brisbane, QLD 4101
Altana Pharma/Nycomed
Toorak Gardens, SA 5056
Altana Pharma/Nycomed
Wayville, SA 5034
South Africa15 sites
Altana Pharma/Nycomed
Arcadia, Pretoria, 132
Altana Pharma/Nycomed
Bellville, Cape Town, 7530
Altana Pharma/Nycomed
Berea, Durban, 4000
Altana Pharma/Nycomed
Bloemfontein, 9300
Altana Pharma/Nycomed
Bloemfontein, 9301
Altana Pharma/Nycomed
Cape Town, 7764
Altana Pharma/Nycomed
Centurion, Pretoria, 157
Altana Pharma/Nycomed
Daveyton, 1520
Altana Pharma/Nycomed
Durban, Amanzimtoti, 4126
Altana Pharma/Nycomed
George, 6539
Altana Pharma/Nycomed
Midrand, 1685
Altana Pharma/Nycomed
Mowbray, Cape Town, 7925
Altana Pharma/Nycomed
Paarl, 7646
Altana Pharma/Nycomed
Panorama / RSA-Cape Town, 7500
Altana Pharma/Nycomed
Pretoria, 186
Spain14 sites
Altana Pharma/Nycomed
Alcorcón (Madrid), 28922
Altana Pharma/Nycomed
Alicante, 3001
Altana Pharma/Nycomed
Alicante, 3540
Altana Pharma/Nycomed
Barcelona, 8222
Altana Pharma/Nycomed
Campdevanol (Girona), 17530
Altana Pharma/Nycomed
Elda (Alicante), 3600
Altana Pharma/Nycomed
Guadalajara, 19002
Altana Pharma/Nycomed
Leganes (Madrid), 28914
Altana Pharma/Nycomed
Palma de Mallorca, 7014
Altana Pharma/Nycomed
Peralada (Girona), 17491
Altana Pharma/Nycomed
Petrer (Alicante), 3610
Altana Pharma/Nycomed
San Vicente Del Raspeig (Alicante), 3187
Altana Pharma/Nycomed
Santiago de Compostela, 15706
Altana Pharma/Nycomed
Valencia, 46017
Hungary9 sites
Altana Pharma/Nycomed
Budapest, 1046
Altana Pharma/Nycomed
Budapest, 1134
Altana Pharma/Nycomed
Budapest, 1529
Altana Pharma/Nycomed
Budapest XI, 1117
Altana Pharma/Nycomed
Budapet, 1529
Altana Pharma/Nycomed
Kecskemét, 6000
Altana Pharma/Nycomed
Nyíregyháza, 4400
Altana Pharma/Nycomed
Szarvas, 5540
Altana Pharma/Nycomed
Tatabánya, 2800
Poland9 sites
Altana Pharma/Nycomed
Bydgoszcz, 85-091
Altana Pharma/Nycomed
Bydgoszcz, 85-681
Altana Pharma/Nycomed
Lodz, 91-520
Altana Pharma/Nycomed
Lódz', 90-153
Altana Pharma/Nycomed
Rzeszów, 35-068
Altana Pharma/Nycomed
Rzeszów, 35-302
Altana Pharma/Nycomed
Warsaw, 01-138
Altana Pharma/Nycomed
Wroclaw, 50-417
Altana Pharma/Nycomed
Wroclaw, 53-674
About this study
Official title: Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
- Conditions
- Asthma
- Being tested
- Ciclesonide
- Keywords
- Asthma, Ciclesonide, Fluticasone propionate, Salmeterol
- 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.
time until the first severe asthma exacerbation occurs
number of poorly controlled asthma days.
Secondary outcomes (14)
percentage of days with asthma control
percentage of days with asthma symptoms
percentage of nocturnal awakenings due to asthma
asthma symptom score
number of inhalations of rescue medication
proportion of patients with severe asthma exacerbations
differences in morning PEF from diary
differences in FEV1 and FVC from spirometry
blood eosinophils
AQLQ(S)
health economic data
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 startSep 2003
- Primary completionOct 2005
- Study completionOct 2005
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 630 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
- NCT00163358
- Sponsor's protocol ID
- BY9010/M1-132
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2005
- Last updated
- 30 Nov 2016
- Results posted
- No
Publications
Postma DS, O'Byrne PM, Pedersen S. Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control. Chest. 2011 Feb;139(2):311-318. doi: 10.1378/chest.09-1735. Epub 2010 Nov 18.
PubMed 21088114
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
- Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
- ClinicalTrials.gov ID
- NCT00163358
- Acronym / sponsor ID
- BY9010/M1-132
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide, Fluticasone propionate, Salmeterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 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 fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). 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
time until the first severe asthma exacerbation occurs
number of poorly controlled asthma days.
14 secondary outcomes
percentage of days with asthma control
percentage of days with asthma symptoms
percentage of nocturnal awakenings due to asthma
asthma symptom score
number of inhalations of rescue medication
proportion of patients with severe asthma exacerbations
differences in morning PEF from diary
differences in FEV1 and FVC from spirometry
blood eosinophils
AQLQ(S)
health economic data
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 30 Nov 2016.
- Derived from this study: PubMed 21088114Postma DS, O'Byrne PM, Pedersen S. Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control. Chest. 2011 Feb;139(2):311-318. doi: 10.1378/chest.09-1735. Epub 2010 Nov 18.
- BY9010-MI-132-RDS-2007-02-12.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
111 sites in 7 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 111 sites in 7 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 111 sites in Canada, Czechia, Australia, South Africa, Spain and 2 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. 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 until the first severe asthma exacerbation occurs. 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?
On the ClinicalTrials.gov record for NCT00163358, 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 30 Nov 2016.