Small Particle Steroids in Refractory Asthma (SPIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01171365
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : January 31, 2014
Nottingham University Hospitals NHS Trust
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Nottingham

June 24, 2010
July 28, 2010
January 31, 2014
January 2010
October 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01171365 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
Small Particle Steroids in Refractory Asthma
Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Ciclesonide
    Inhaled ciclesonide 320mcg twice daily
    Other Name: Alvesco
  • Drug: Placebo
    Matched placebo inhaler two inhalations twice daily
  • Active Comparator: Ciclesonide
    Ciclesonide 320 microgrammes twice daily
    Intervention: Drug: Ciclesonide
  • Placebo Comparator: Placebo
    Placebo 2 inhalations twice daily
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
University of Nottingham
University of Nottingham
  • Nottingham University Hospitals NHS Trust
  • University Hospitals, Leicester
Principal Investigator: Tim Harrison University of Nottingham
Principal Investigator: Ian Pavord University Hospitals, Leicester
University of Nottingham
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP