Status:
COMPLETED
Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity
Lead Sponsor:
Bispebjerg Hospital
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03321877
Start Date
October 1 2016
End Date
May 31 2017
Last Update
October 26 2017
Active Locations (1)
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1
Lungemedicinsk Forskningsenhed
Copenhagen, Denmark, 2400