Small Particle Steroids in Refractory Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ciclesonide

Ciclesonide 320 microgrammes twice daily

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

Inhaled ciclesonide 320mcg twice daily

Placebo

Placebo 2 inhalations twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo inhaler two inhalations twice daily

Interventions

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Ciclesonide

Inhaled ciclesonide 320mcg twice daily

Intervention Type DRUG

Placebo

Matched placebo inhaler two inhalations twice daily

Intervention Type DRUG

Other Intervention Names

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Alvesco

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No