Small Particle Steroids in Refractory Asthma

University of Nottingham30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

CiclesonideDRUG

Inhaled ciclesonide 320mcg twice daily

PlaceboDRUG

Matched placebo inhaler two inhalations twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Outcomes

Primary Outcomes

Change in sputum eosinophil count over the trial period

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

Time frame: 0 weeks (start), 8 weeks (finish)

Secondary Outcomes

Change in alveolar nitric oxide level over the trial period

alveolar nitric oxide has been shown to correlate with eosinophil count on BAL samples. Measured by measuring exhaled nitric oxide at multiple flow rates.