Small Particle Steroids in Refractory Asthma
- Registration Number
- NCT01171365
- Lead Sponsor
- University of Nottingham
- 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 relatively proximal airway distribution which may lead to inadequate treatment of the distal airways.
We aim to demonstrate that a steroid inhaler with a smaller particle size which targets the distal airways can be a useful additional treatment option in this group of patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 2 inhalations twice daily Ciclesonide Ciclesonide Ciclesonide 320 microgrammes twice daily
- Primary Outcome Measures
Name Time Method Change in sputum eosinophil count over the trial period 0 weeks (start), 8 weeks (finish) Sputum will be processed for a differential cell count, with the primary outcome the difference in sputum eosinophil count between active and placebo groups at 8 weeks
- Secondary Outcome Measures
Name Time Method Change in Juniper Asthma Control Questionnaire (ACQ) score 0 weeks (start), 4 weeks, 8 weeks (finish) UK English Version 2001
Use of oral steroid over the trial period 0-8 weeks Dose and duration of any additional oral corticosteroid will be documented
Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score 0 weeks (start), 4 weeks, 8 weeks (finish) Self-administered United Kingdom Version 1994
Number of patients with adverse events as a measure of safety and tolerability 0-8 weeks Adverse events will be recorded throughout the trial period
Change in alveolar nitric oxide level over the trial period 0 weeks (start), 4 weeks, 8 weeks (finish) alveolar nitric oxide has been shown to correlate with eosinophil count on BAL samples. Measured by measuring exhaled nitric oxide at multiple flow rates.
Change in bronchial nitric oxide level 0 weeks (start), 4 weeks, 8 weeks (finish) Measured by single flow exhaled nitric oxide at 50 ml/s
Change in prebronchodilator FEV1 0 weeks (start), 4 weeks, 8 weeks (finish) Prebronchodilator FEV1 and FVC will be recorded with a Vitalograph Wedge Bellows spirometer
Trial Locations
- Locations (2)
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, Leicestershire, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, Nottinghamshire, United Kingdom