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Small Particle Steroids in Refractory Asthma (SPIRA)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Ciclesonide
Placebo
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
June 24, 2010
Last Updated
January 30, 2014
Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust, University Hospitals, Leicester
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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
No

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
0 weeks (start), 4 weeks, 8 weeks (finish)
Title
Change in bronchial nitric oxide level
Description
Measured by single flow exhaled nitric oxide at 50 ml/s
Time Frame
0 weeks (start), 4 weeks, 8 weeks (finish)
Title
Change in prebronchodilator FEV1
Description
Prebronchodilator FEV1 and FVC will be recorded with a Vitalograph Wedge Bellows spirometer
Time Frame
0 weeks (start), 4 weeks, 8 weeks (finish)
Title
Change in Juniper Asthma Control Questionnaire (ACQ) score
Description
UK English Version 2001
Time Frame
0 weeks (start), 4 weeks, 8 weeks (finish)
Title
Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score
Description
Self-administered United Kingdom Version 1994
Time Frame
0 weeks (start), 4 weeks, 8 weeks (finish)
Title
Use of oral steroid over the trial period
Description
Dose and duration of any additional oral corticosteroid will be documented
Time Frame
0-8 weeks
Title
Number of patients with adverse events as a measure of safety and tolerability
Description
Adverse events will be recorded throughout the trial period
Time Frame
0-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Harrison
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian Pavord
Organizational Affiliation
University Hospitals, Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25858909
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.
Results Reference
derived

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Small Particle Steroids in Refractory Asthma

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