Small Particle Steroids in Refractory Asthma

Condition(s) targeted: Asthma

Intervention: Ciclesonide (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Nottingham

Official(s) and/or principal investigator(s):
Tim Harrison, Principal Investigator, Affiliation: University of Nottingham
Ian Pavord, Principal Investigator, Affiliation: University Hospitals, Leicester

Overall contact:
Tim Harrison, Phone: +44 1159691169, Ext: 56317, Email: tim.harrison@nottingham.ac.uk

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.

Official title: Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in sputum eosinophil count over the trial period

Secondary outcome:

Change in alveolar nitric oxide level over the trial period

Change in bronchial nitric oxide level

Change in prebronchodilator FEV1

Change in Juniper Asthma Control Questionnaire (ACQ) score

Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score

Use of oral steroid over the trial period

Number of patients with adverse events as a measure of safety and tolerability

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Tim Harrison, Phone: +44 1159691169, Ext: 56317, Email: tim.harrison@nottingham.ac.uk

University Hospitals of Leicester NHS Trust, Leicester, Leicestershire LE3 9QP, United Kingdom; Recruiting
Ian Pavord, Phone: +44 1162502373, Email: ian.pavord@uhl-tr.nhs.uk
Ian Pavord, Principal Investigator

Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire NG5 1PB, United Kingdom; Recruiting
Tim Harrison, Phone: +44 1159691169, Ext: 56317, Email: tim.harrison@nottingham.ac.uk
David Hodgson, Phone: +44 1158231695, Email: david.hodgson@nottingham.ac.uk
Tim Harrison, Principal Investigator
David Hodgson, Sub-Investigator
Dominick Shaw, Sub-Investigator
John Anderson, Sub-Investigator

NIHR Nottingham Respiratory BRU Webpage

Starting date: October 2010
Last updated: December 3, 2012