Clinical trial NCT01171365: Small Particle Steroids in Refractory Asthma
Official title: Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Ciclesonide
Asthma
Therapeutic Uses
Pulmonary Eosinophilia
Nitric Oxide
Lung Diseases
Respiratory Tract Diseases
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
name: University Hospitals, Leicester
First posted: 2010-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change in sputum eosinophil count over the trial period
timeFrame: 0 weeks (start), 8 weeks (finish)
Secondary outcomes:
measure: Change in alveolar nitric oxide level over the trial period
timeFrame: 0 weeks (start), 4 weeks, 8 weeks (finish)
measure: Change in bronchial nitric oxide level
timeFrame: 0 weeks (start), 4 weeks, 8 weeks (finish)
measure: Change in prebronchodilator FEV1
timeFrame: 0 weeks (start), 4 weeks, 8 weeks (finish)
measure: Change in Juniper Asthma Control Questionnaire (ACQ) score
timeFrame: 0 weeks (start), 4 weeks, 8 weeks (finish)
measure: Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score
timeFrame: 0 weeks (start), 4 weeks, 8 weeks (finish)
measure: Use of oral steroid over the trial period
timeFrame: 0-8 weeks
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: 0-8 weeks
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
state: Leicestershire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Tim Harrison
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals, Leicester
name: Ian Pavord
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hodgson D, Anderson J, Reynolds C, Meakin G, Bailey H, Pavord I, Shaw D, Harrison T. A randomised controlled trial of small particle inhaled steroids in refractory eosinophilic asthma (SPIRA). Thorax. 2015 Jun;70(6):559-65. doi: 10.1136/thoraxjnl-2014-206481. Epub 2015 Apr 9.