AsthmaDOSISNCT03321877
Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity
A study testing Change to dose of patient's regular medication in people with Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Change to dose of patient's regular medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2016to 31 May 2017
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-diagnosed asthma for at least 6 months
- Fulfill ERS/ATS giudelines for severe asthma
- Stable dose of ICS for at least 4 weeks
- Able to carry out study procedures
- Negative metacholine provocation test at screening
- Negative reversibility to beta agonist at screening
- FeNO under 50 ppb
Who cannot join
- Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months
- FEV1 under 70% of predicted
- Acute upper or lower airway infection requiring antibiotics in the last 4 weeks
- Exacerbation of asthma requiring prednisolone in the last 6 months
- Current smoking
- Pregnancy or breastfeeding
- Other clinically significant lung disease
- Current participation in another interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity: Severe Asthma or Simply Over-treatment?
An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.
Read the detailed description
We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects.
This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control.
After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.
- Conditions
- Asthma
- Being tested
- Change to dose of patient's regular medication
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change to dose of patient's regular medicationDrug
Dose reduction of the drug each patient was already taking
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | All included patients underwent dose reduction. Receives: Drug: Change to dose of patient's regular medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsiveness to metacholine bronchial challenge
PD(20) if positive test
Measured: 8 weeks
Secondary outcomes (5)
ACQ score
asthma control questionnaire
Measured: 8 weeks
miniAQLQ score
asthma quality of life score
Measured: 8 weeks
Pulmonary function tests
FEV1, FVC, reversibility to beta agonist
Measured: 8 weeks
FeNO
fraction of exhaled nitric oxide
Measured: 8 weeks
Sputum cell differentials
sputum neutrophil and eosinophil counts
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Oct 2016
- Primary completion31 May 2017
- Study completion31 May 2017
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.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eileen Wedge, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321877
- Sponsor's protocol ID
- 55855
- Acronym
- DOSIS
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity: Severe Asthma or Simply Over-treatment?
- ClinicalTrials.gov ID
- NCT03321877
- Acronym / sponsor ID
- DOSIS / 55855
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 26 Oct 2017 (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.
An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.
Detailed description
We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects.
This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control.
After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Change to dose of patient's regular medicationAll included patients underwent dose reduction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Physician-diagnosed asthma for at least 6 months
- Fulfill ERS/ATS giudelines for severe asthma
- Stable dose of ICS for at least 4 weeks
- Able to carry out study procedures
- Negative metacholine provocation test at screening
Key exclusion criteria (8 listed)
- Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months
- FEV1 under 70% of predicted
- Acute upper or lower airway infection requiring antibiotics in the last 4 weeks
- Exacerbation of asthma requiring prednisolone in the last 6 months
- Current smoking
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 |
|---|---|---|
| Change to dose of patient's regular medicationDose reduction of the drug each patient was already taking | Drug | Study group |
Primary outcome
Responsiveness to metacholine bronchial challenge
Time frame: 8 weeks
PD(20) if positive test
5 secondary outcomes
ACQ score
Time frame: 8 weeks
miniAQLQ score
Time frame: 8 weeks
Pulmonary function tests
Time frame: 8 weeks
FeNO
Time frame: 8 weeks
Sputum cell differentials
Time frame: 8 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 26 Oct 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change to dose of patient's regular medication in people with Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
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 7 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 26 Oct 2017. 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 Denmark. 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.
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?
Responsiveness to metacholine bronchial challenge (time frame: 8 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 26 Oct 2017.