Back to results

Small Particle Steroids in Refractory Asthma (SPIRA)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Ciclesonide

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Ciclesonide, Asthma, Therapeutic Uses, Pulmonary Eosinophilia, Nitric Oxide, Lung Diseases, Respiratory Tract Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospitals of Leicester NHS Trust
Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ciclesonide

Placebo

Arm Description

Ciclesonide 320 microgrammes twice daily

Placebo 2 inhalations twice daily

Outcomes

Primary Outcome Measures

Change in sputum eosinophil count over the trial period

Sputum will be processed for a differential cell count, with the primary outcome the difference in sputum eosinophil count between active and placebo groups at 8 weeks

Secondary Outcome Measures

Change in alveolar nitric oxide level over the trial period

alveolar nitric oxide has been shown to correlate with eosinophil count on BAL samples. Measured by measuring exhaled nitric oxide at multiple flow rates.

Change in bronchial nitric oxide level

Measured by single flow exhaled nitric oxide at 50 ml/s

Change in prebronchodilator FEV1

Prebronchodilator FEV1 and FVC will be recorded with a Vitalograph Wedge Bellows spirometer

Change in Juniper Asthma Control Questionnaire (ACQ) score

UK English Version 2001

Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score

Self-administered United Kingdom Version 1994

Use of oral steroid over the trial period

Dose and duration of any additional oral corticosteroid will be documented

Number of patients with adverse events as a measure of safety and tolerability

Adverse events will be recorded throughout the trial period

Full Information

NCT ID

NCT01171365

First Posted

June 24, 2010

Last Updated

January 30, 2014

Sponsor

University of Nottingham

Collaborators

Nottingham University Hospitals NHS Trust, University Hospitals, Leicester

1. Study Identification

Unique Protocol Identification Number

NCT01171365

Brief Title

Small Particle Steroids in Refractory Asthma

Acronym

SPIRA

Official Title

Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nottingham

Collaborators

Nottingham University Hospitals NHS Trust, University Hospitals, Leicester

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Ciclesonide, Asthma, Therapeutic Uses, Pulmonary Eosinophilia, Nitric Oxide, Lung Diseases, Respiratory Tract Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ciclesonide

Arm Type

Active Comparator

Arm Description

Ciclesonide 320 microgrammes twice daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 2 inhalations twice daily

Intervention Type

Drug

Intervention Name(s)

Ciclesonide

Other Intervention Name(s)

Alvesco

Intervention Description

Inhaled ciclesonide 320mcg twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matched placebo inhaler two inhalations twice daily

Primary Outcome Measure Information:

Title

Change in sputum eosinophil count over the trial period

Description

Sputum will be processed for a differential cell count, with the primary outcome the difference in sputum eosinophil count between active and placebo groups at 8 weeks

Time Frame

0 weeks (start), 8 weeks (finish)

Secondary Outcome Measure Information:

Title

Change in alveolar nitric oxide level over the trial period

Description

alveolar nitric oxide has been shown to correlate with eosinophil count on BAL samples. Measured by measuring exhaled nitric oxide at multiple flow rates.

Time Frame