Asthma
Conditions
Keywords
Ciclesonide, Asthma, Therapeutic Uses, Pulmonary Eosinophilia, Nitric Oxide, Lung Diseases, Respiratory Tract Diseases
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.
Interventions
DRUGCiclesonide
Inhaled ciclesonide 320mcg twice daily
DRUGPlacebo
Matched placebo inhaler two inhalations twice daily
Sponsors
Nottingham University Hospitals NHS Trust
University Hospitals, Leicester
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in Juniper Asthma Control Questionnaire (ACQ) score | 0 weeks (start), 4 weeks, 8 weeks (finish) | UK English Version 2001 |
| 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. |
| Use of oral steroid over the trial period | 0-8 weeks | Dose and duration of any additional oral corticosteroid will be documented |
| 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 Juniper Asthma Quality of Life Questionnaire (AQLQ) score | 0 weeks (start), 4 weeks, 8 weeks (finish) | Self-administered United Kingdom Version 1994 |
Countries
United Kingdom
Outcome results
None listed