Small Particle Steroids in Refractory Asthma (SPIRA)
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ClinicalTrials.gov Identifier: NCT01171365 |
Recruitment Status :
Completed
First Posted : July 28, 2010
Last Update Posted : January 31, 2014
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Condition or disease | Intervention/treatment | Phase |
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Asthma | Drug: Ciclesonide Drug: Placebo | Phase 4 |
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 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 |

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
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Drug: Placebo
Matched placebo inhaler two inhalations twice daily |
- 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
- 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.
- 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
- 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
- Change in Juniper Asthma Control Questionnaire (ACQ) score [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ]UK English Version 2001
- 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
- Use of oral steroid over the trial period [ Time Frame: 0-8 weeks ]Dose and duration of any additional oral corticosteroid will be documented
- 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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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
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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
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Use of a medication which may interact with ciclesonide:
- ketoconazole or itraconazole
- ritonavir, nelfinavir

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171365
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 |
Principal Investigator: | Tim Harrison | University of Nottingham | |
Principal Investigator: | Ian Pavord | University Hospitals, Leicester |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Nottingham |
ClinicalTrials.gov Identifier: | NCT01171365 History of Changes |
Other Study ID Numbers: |
09115 |
First Posted: | July 28, 2010 Key Record Dates |
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 |