Small Particle Steroids in Refractory Asthma
Information source: University of Nottingham
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Ciclesonide (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
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
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.
Clinical Details
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 periodChange 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.
Eligibility
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
Locations and Contacts
University Hospitals of Leicester NHS Trust, Leicester, Leicestershire LE3 9QP, United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire NG5 1PB, United Kingdom
Additional Information
NIHR Nottingham Respiratory BRU Webpage
Starting date: January 2010
Last updated: January 30, 2014
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