Small Particle Steroids in Refractory Asthma (SPIRA)

This study has been completed.
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01171365
First received: June 24, 2010
Last updated: January 30, 2014
Last verified: January 2014

June 24, 2010
January 30, 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) ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Change in alveolar nitric oxide level over the trial period [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    UK English Version 2001
  • Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ] [ Designated as safety issue: No ]
    Self-administered United Kingdom Version 1994
  • Use of oral steroid over the trial period [ Time Frame: 0-8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01171365
09115
No
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