Asthma, BronchialPhase 4MACSNCT03839433
The Mannitol-Asthma-Ciclesonide-Study
A Phase 4 study testing Ciclesonide in people with Asthma, Bronchial, run by Cantonal Hospital, Baselland.
Trial summary
Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway hyperresponsiveness assessed with mannitol. Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of hyper-responsive patients compared to 20% only in the placebo group and the group without airway… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma, Bronchial
- What is being tested?
- Ciclesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Aug 2008
- 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 (Global Initiative for Asthma, October 2006) 1 week prior to randomization
- FEV1 ≥ 70% predicted
Who cannot join
- Smoker and ex-smoker with >10 pack years
- COPD (chronic obstructive pulmonary disease)
- Upper respiratory tract infection within the past 4 weeks.
- ICS or oral steroids during the previous month before inclusion
- beta-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
About this study
Official title: Ciclesonide for the Treatment of Airway Hyperresponsiveness: The Mannitol-Asthma-Ciclesonide-Study
Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway hyperresponsiveness assessed with mannitol.
Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of hyper-responsive patients compared to 20% only in the placebo group and the group without airway hyper-responsiveness.
- Conditions
- Asthma, Bronchial
- Being tested
- Ciclesonide
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclesonideDrug
| Study group | Role | What they receive |
|---|---|---|
| ciclesonide positive | Active comparator | Half of the Mannitol positive patients were given ciclesonide. Half of the Mannitol negative patients were given ciclesonide. All patients in the "ciclesonide positive" arm received ciclesonide. Receives: Drug: Ciclesonide |
| Placebo | Placebo comparator | Half of the Mannitol positive patients were given a placebo. Half of the Mannitol negative patients were given a placebo. All patients in the "placebo" arm received placebo. Receives: Drug: Ciclesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)
measurements of PD15 FEV1 (provocative dose to produce a 15% fall in FEV1), bronchial hyperresponsiveness. A 15 % reduction of FEV1 means a bronchial hyperresponsiveness
Measured: 4 weeks
Secondary outcomes (4)
Change in PD20 FEV1 methacholine (Responsiveness to metacholine)
measurements of PD20 FEV1 (provocative dose to produce a 20% fall in FEV1) bronchial hyperresponsiveness. A 20 % reduction of FEV1 means a bronchial hyperresponsiveness
Measured: 4 weeks
Change in FeNO (Nitric Oxide)
Measurement of bronchial inflammation. It determines the level of nitric oxide in parts per billion (PPB). Nitric oxide in exhaled air is another marker of airway inflammation. Subjects with atopic asthma or rhinitis seem to have elevated expiratory nitric oxide (eNO) levels.
Measured: 4 weeks
Change in ACQ (Asthma Control Questionnaire)
It measures both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. It measures both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
Measured: 4 weeks
AQLQ (Asthma Quality of Life Questionnaire)
The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains.
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 posted15 Feb 2019
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, BronchialStudies of the same condition, open and under way.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Baselland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Jörg Leuppi, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839433
- Sponsor's protocol ID
- BY 9010 / CH-101
- Acronym
- MACS
- Status last verified
- Jul 2019
- First submitted
- 4 Aug 2017
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. 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
- ClinicalTrials.gov ID
- NCT03839433
- Acronym / sponsor ID
- MACS / BY 9010 / CH-101
- Conditions
- Asthma, Bronchial
- Keywords
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cantonal Hospital, BasellandUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Feb 2019 (actual)
- 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.
Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway hyperresponsiveness assessed with mannitol.
Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of hyper-responsive patients compared to 20% only in the placebo group and the group without airway hyper-responsiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ciclesonide positive | Active comparator | Drug: CiclesonideHalf of the Mannitol positive patients were given ciclesonide. Half of the Mannitol negative patients were given ciclesonide. All patients in the "ciclesonide positive" arm received ciclesonide. |
| Placebo | Placebo comparator | Drug: CiclesonideHalf of the Mannitol positive patients were given a placebo. Half of the Mannitol negative patients were given a placebo. All patients in the "placebo" arm received placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 (Global Initiative for Asthma, October 2006) 1 week prior to randomization
- FEV1 ≥ 70% predicted
Key exclusion criteria (8 listed)
- Smoker and ex-smoker with >10 pack years
- COPD (chronic obstructive pulmonary disease)
- Upper respiratory tract infection within the past 4 weeks.
- ICS or oral steroids during the previous month before inclusion
- beta-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 |
|---|---|---|
| Ciclesonide | Drug | Placebo, ciclesonide positive |
Primary outcome
Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)
Time frame: 4 weeks
measurements of PD15 FEV1 (provocative dose to produce a 15% fall in FEV1), bronchial hyperresponsiveness. A 15 % reduction of FEV1 means a bronchial hyperresponsiveness
4 secondary outcomes
Change in PD20 FEV1 methacholine (Responsiveness to metacholine)
Time frame: 4 weeks
Change in FeNO (Nitric Oxide)
Time frame: 4 weeks
Change in ACQ (Asthma Control Questionnaire)
Time frame: 4 weeks
AQLQ (Asthma Quality of Life Questionnaire)
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 25 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciclesonide in people with Asthma, Bronchial, run by Cantonal Hospital, Baselland.
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 3 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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose) (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 25 Jul 2019.