Status:
COMPLETED
Small Particle Steroids in Refractory Asthma
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Nottingham University Hospitals NHS Trust
University Hospitals, Leicester
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether an inhaled steroid with a small particle size can be an additional treatment option in patients with refractory eosinophilic asthma.
Detailed Description
We have identified a group of patients with refractory asthma who have ongoing eosinophilic airway inflammation despite high dose inhaled corticosteroids. Traditional inhaled steroids have a relative...
Eligibility Criteria
Inclusion
- Age 18-80
- ACQ \>1.5 or a requirement for oral steroids twice a year or more
- High dose inhaled steroid (\>1000mcg BDP or equivalent)
- Treatment with or unsuccessful trial of:
- long-acting beta agonist
- leukotriene antagonist
- Sputum eosinophil count \>3% despite high dose inhaled steroid or \>2% with serum eosinophils \>0.4x10exp9/l
- Clinical response to 2 weeks of oral prednisolone: (any one)
- reduction in ACQ by 0.5 or more
- increase in FEV1 by 200ml
- normalisation of exhaled nitric oxide or reduction of \>25ppb
Exclusion
- Current smoker, or ex-smoker for \<12 months
- Current treatment with an extrafine steroid inhaler
- Respiratory infection within the last 4 weeks
- Pregnancy or lactation
- Poor compliance with usual asthma medication
- Clinical diagnosis of significant bronchiectasis
- Use of a medication which may interact with ciclesonide:
- ketoconazole or itraconazole
- ritonavir, nelfinavir
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01171365
Start Date
January 1 2010
End Date
December 1 2013
Last Update
January 31 2014
Active Locations (2)
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1
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE3 9QP
2
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB