Small Particle Steroids in Refractory Asthma

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nottingham
• Collaborators: Nottingham University Hospitals NHS Trust; University Hospitals, Leicester
• Treatments: Ciclesonide

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