Refractory Asthma MedDRA version: 12. Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Alvesco 160 inhaler
Product Name: Ciclesonide
Pharmaceutical Form: Pressurised inhalation*
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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? 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. | — |
Countries
United Kingdom
Outcome results
None listed