Small Particle Steroids in Refractory Asthma (SPIRA)

University of Nottingham

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Ciclesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT01171365

09115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Ciclesonide

Active Comparator group

Description:

Ciclesonide 320 microgrammes twice daily

Treatment:

Drug: Ciclesonide

Placebo

Placebo Comparator group

Description:

Placebo 2 inhalations twice daily

Treatment:

Drug: Placebo