AsthmaPhase 2NCT00314509
Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
A Phase 2 study testing Ciclesonide/Formoterol Combination in people with Asthma, run by AstraZeneca at 26 sites in 4 countries.
Trial summary
The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ciclesonide/Formoterol Combination
- How many people
- 240 participants
- Where
- 26 sitesin 4 countries
- Study dates
- Jul 2005to Jan 2006
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Written informed consent
- Good health with the exception of bronchial asthma (for at least 6 months)
- FEV1 > 60% to < 80% of predicted (if pretreated with inhaled steroids only)
- FEV1 > 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller)
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists
- Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function
- Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years
- Use of other drugs not allowed
- Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
Hungary12 sites
Altana Pharma/Nycomed
Balassagyarmat, 2660
Altana Pharma/Nycomed
Balatonfüred, 8230
Altana Pharma/Nycomed
Budapest, 1125
Altana Pharma/Nycomed
Budapest, 1529
Altana Pharma/Nycomed
Csorna, 9300
Altana Pharma/Nycomed
Debrecen, 4043
Altana Pharma/Nycomed
Győr, 9024
Altana Pharma/Nycomed
Mátraháza, 3233
Altana Pharma/Nycomed
Mosonmagyaróvár, 9200
Altana Pharma/Nycomed
Nyíregyháza, 4400
Altana Pharma/Nycomed
Szolnok, 5006
Altana Pharma/Nycomed
Szombathely, 9700
South Africa7 sites
Altana Pharma/Nycomed
Arcadia, Pretoria, 132
Altana Pharma/Nycomed
Bellville, Cape Town, 7530
Altana Pharma/Nycomed
Bloemfontein, 9300
Altana Pharma/Nycomed
Cape Town, Tygerberg, 7505
Altana Pharma/Nycomed
Mowbray, Cape Town, 7925
Altana Pharma/Nycomed
Panorama / RSA-Cape Town, 7500
Altana Pharma/Nycomed
Pretoria
Germany5 sites
Altana Pharma/Nycomed
Berlin, 14050
Altana Pharma/Nycomed
Großhansdorf, 22927
Altana Pharma/Nycomed
Mainz, 55131
Altana Pharma/Nycomed
Rüdersdorf, 15562
Altana Pharma/Nycomed
Wiesbaden, 65187
France2 sites
Altana Pharma/Nycomed
Grenoble, 38100
Altana Pharma/Nycomed
Montpellier, 34295
About this study
Official title: ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients
The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.
- Conditions
- Asthma
- Being tested
- Ciclesonide/Formoterol Combination
- Keywords
- Asthma, Ciclesonide, Formoterol Fumarate, Long-acting beta2-agonists, LABA, Steroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide/Formoterol CombinationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first experience of lack of efficacy
AUC (FEV1) over a 24 h dosing interval.
Secondary outcomes (3)
FEV1
morning and evening PEF, asthma symptoms and use of rescue medication
proportion of patients with a clinical asthma exacerbation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startJul 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 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
- NCT00314509
- Sponsor's protocol ID
- BY9010/M1-506
- Status last verified
- Dec 2016
- First submitted
- 11 Apr 2006
- 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
- ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT00314509
- Acronym / sponsor ID
- BY9010/M1-506
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide, Formoterol Fumarate, Long-acting beta2-agonists, LABA, Steroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 14 Apr 2006 (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 two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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/Formoterol Combination | Drug | – |
Primary outcome
Time to the first experience of lack of efficacy
AUC (FEV1) over a 24 h dosing interval.
3 secondary outcomes
FEV1
morning and evening PEF, asthma symptoms and use of rescue medication
proportion of patients with a clinical asthma exacerbation.
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 M1-506.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
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciclesonide/Formoterol Combination in people with Asthma, run by AstraZeneca at 26 sites in 4 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 26 sites in Hungary, South Africa, Germany, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 the first experience of lack of efficacy. 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.