AsthmaPhase 4NCT00826969
Ciclesonide for the Treatment of Airway Hyperresponsiveness
A Phase 4 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 1 site in Switzerland.
Trial summary
The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2008to Oct 2011
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
- Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to randomization
- FEV1 ≥ 70% predicted
- 18 - 70 years old
Who cannot join
- Smoker and ex-smoker with >10 pack years
- COPD
- Upper respiratory tract infection within the past 4 weeks.
- ICS or oral steroids during the previous month before inclusion
- b-blockers within the past 4 weeks
- Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
- Pregnancy
- Known malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-blind, Randomized, Parallel Group Study.
The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.
- Conditions
- Asthma
- Being tested
- Ciclesonide, Placebo
- 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
320µg Ciclesonide versus Placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ciclesonide 320µg Receives: Drug: Ciclesonide |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo
Measured: 4 weeks
Secondary outcomes (8)
RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)
Measured: 4 weeks
Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment
Measured: 4 weeks
Level of exhaled nitric oxide after 4 weeks of treatment
Measured: 4 weeks
mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)
Measured: 4 weeks
Mean change of ACQ after 4 weeks of treatment
Measured: 4 weeks
Mean change of AQLQ after 4 weeks of treatment
Measured: 4 weeks
Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment
Measured: 4 weeks
Exacerbation rates during the 4 weeks of treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2010
- Study completionOct 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
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
- NCT00826969
- Sponsor's protocol ID
- BY9010/CH-101
- Other IDs
- U1111-1137-3949
- Status last verified
- Oct 2016
- First submitted
- 21 Jan 2009
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- 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
- Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-blind, Randomized, Parallel Group Study.
- ClinicalTrials.gov ID
- NCT00826969
- Acronym / sponsor ID
- BY9010/CH-101
- Conditions
- Asthma
- Keywords
- Asthma, Ciclesonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jan 2009 (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 study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CiclesonideCiclesonide 320µg |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
- Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to randomization
- FEV1 ≥ 70% predicted
- 18 - 70 years old
Key exclusion criteria (8 listed)
- Smoker and ex-smoker with >10 pack years
- COPD
- Upper respiratory tract infection within the past 4 weeks.
- ICS or oral steroids during the previous month before inclusion
- b-blockers within the past 4 weeks
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 |
|---|---|---|
| Ciclesonide320µg Ciclesonide versus Placebo | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo
Time frame: 4 weeks
8 secondary outcomes
RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)
Time frame: 4 weeks
Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment
Time frame: 4 weeks
Level of exhaled nitric oxide after 4 weeks of treatment
Time frame: 4 weeks
mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)
Time frame: 4 weeks
Mean change of ACQ after 4 weeks of treatment
Time frame: 4 weeks
Mean change of AQLQ after 4 weeks of treatment
Time frame: 4 weeks
Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment
Time frame: 4 weeks
Exacerbation rates during the 4 weeks of treatment
Time frame: 4 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 2 Dec 2016.
- BY9010-CH-101-RDS-2012-10-29.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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. 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 1 site in Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo (time frame: 4 weeks). 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.