Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma - Small Particle Steroids in Asthma. V1

Conditions: Refractory Asthma
MedDRA version: 12.Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2010-018249-78-GB

Lead Sponsor: niversity of Nottingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Non-smokers with refractory asthma (ACQ score =1.5 or requirement for oral steroids =twice per year despite treatment with high dose inhaled steroid and treatment with, or unsuccessful trial of, a long acting beta-2 agonist or leukotriene antagonist).

Sputum eosinophil count >3%

A response to a 2 week trial of oral steroids, defined as a reduction in ACQ score by 0.5, an increase in FEV1 of 200ml, or either normalisation or a fall in exhaled NO of =25 ppb.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Poor compliance with usual asthma treatment

Pregnancy, inadequate contraception or lactation

Active smoking or smoking history of >10 pack-years

Clinical diagnosis of ABPA or significant bronchiectasis

Another significant, active, medical co-morbidity

Use of a medication which interacts with ciclesonide (ketoconazole, itraconazole, ritonavir, nelfinavir)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In patients with poorly controlled asthma with evidence of persistent eosinophilic inflammation can the addition of extra inhaled corticosteroid that targets the distal airways improve asthma control and reduce the eosinophilic airway inflammation?<br><br>The primary endpoint will be the difference in sputum eosinophil count between active and placebo groups at 8 weeks.;Secondary Objective: The secondary endpoints are differences in bronchial nitric oxide, alveolar nitric oxide, forced expiratory volume in 1 second (FEV1), blood eosinophil count, asthma symptoms, Asthma Control Questionnaire (ACQ) score, Asthma Quality of Life Questionnaire (AQLQ) score, number of exacerbations and use of oral steroid.;Primary end point(s): The difference in sputum eosinophil count between active and placebo groups at 8 weeks.

Secondary Outcome Measures