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
  Purpose

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 Intervention Phase
Asthma
Drug: Ciclesonide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 30
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171365

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

Additional Information:
No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01171365     History of Changes
Other Study ID Numbers: 09115
Study First Received: June 24, 2010
Last Updated: January 30, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014