Small Particle Steroids in Refractory Asthma (SPIRA)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Ciclesonide; Drug: Placebo	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma
Study Start Date :	January 2010
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Ciclesonide; Ciclesonide 320 microgrammes twice daily	Drug: Ciclesonide; Inhaled ciclesonide 320mcg twice daily; Other Name: Alvesco
Placebo Comparator: Placebo; Placebo 2 inhalations twice daily	Drug: Placebo; Matched placebo inhaler two inhalations twice daily

Outcome Measures

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Primary Outcome Measures :

1. Change in sputum eosinophil count over the trial period [ Time Frame: 0 weeks (start), 8 weeks (finish) ]
   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 :

1. Change in alveolar nitric oxide level over the trial period [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ]
   alveolar nitric oxide has been shown to correlate with eosinophil count on BAL samples. Measured by measuring exhaled nitric oxide at multiple flow rates.
2. Change in bronchial nitric oxide level [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ]
   Measured by single flow exhaled nitric oxide at 50 ml/s
3. Change in prebronchodilator FEV1 [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ]
   Prebronchodilator FEV1 and FVC will be recorded with a Vitalograph Wedge Bellows spirometer
4. Change in Juniper Asthma Control Questionnaire (ACQ) score [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ]
   UK English Version 2001
5. Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ]
   Self-administered United Kingdom Version 1994
6. Use of oral steroid over the trial period [ Time Frame: 0-8 weeks ]
   Dose and duration of any additional oral corticosteroid will be documented
7. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 0-8 weeks ]
   Adverse events will be recorded throughout the trial period

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE3 9QP
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB

Sponsors and Collaborators

University of Nottingham

Nottingham University Hospitals NHS Trust

University Hospitals, Leicester

Investigators

Principal Investigator:	Tim Harrison	University of Nottingham
Principal Investigator:	Ian Pavord	University Hospitals, Leicester

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University of Nottingham
ClinicalTrials.gov Identifier:	NCT01171365 History of Changes
Other Study ID Numbers:	09115
First Posted:	July 28, 2010
Last Update Posted:	January 31, 2014
Last Verified:	January 2014

Keywords provided by University of Nottingham:

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

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity	Immune System Diseases; Ciclesonide; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Allergic Agents