Small Particle Steroids in Refractory Asthma

Asthma Clinical Trial

— SPIRA  

Official title:

Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171365
• Other study ID #: 09115
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2010
• Last updated: January 30, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide
Inhaled ciclesonide 320mcg twice daily
• Placebo
Matched placebo inhaler two inhalations twice daily

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester	Leicestershire
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Nottingham University Hospitals NHS Trust, University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sputum eosinophil count over the trial period	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	0 weeks (start), 8 weeks (finish)	No
Secondary	Change in alveolar nitric oxide level over the trial period	alveolar nitric oxide has been shown to correlate with eosinophil count on BAL samples. Measured by measuring exhaled nitric oxide at multiple flow rates.	0 weeks (start), 4 weeks, 8 weeks (finish)	No
Secondary	Change in bronchial nitric oxide level	Measured by single flow exhaled nitric oxide at 50 ml/s	0 weeks (start), 4 weeks, 8 weeks (finish)	No
Secondary	Change in prebronchodilator FEV1	Prebronchodilator FEV1 and FVC will be recorded with a Vitalograph Wedge Bellows spirometer	0 weeks (start), 4 weeks, 8 weeks (finish)	No
Secondary	Change in Juniper Asthma Control Questionnaire (ACQ) score	UK English Version 2001	0 weeks (start), 4 weeks, 8 weeks (finish)	No
Secondary	Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score	Self-administered United Kingdom Version 1994	0 weeks (start), 4 weeks, 8 weeks (finish)	No
Secondary	Use of oral steroid over the trial period	Dose and duration of any additional oral corticosteroid will be documented	0-8 weeks	No
Secondary	Number of patients with adverse events as a measure of safety and tolerability	Adverse events will be recorded throughout the trial period	0-8 weeks	Yes

External Links

•   NIHR Nottingham Respiratory BRU Webpage