Small Particle Steroids in Refractory Asthma - Full Text View

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:

MedlinePlus related topics: Asthma

Drug Information available for: Ciclesonide

U.S. FDA Resources

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:

NIHR Nottingham Respiratory BRU Webpage This link exits the ClinicalTrials.gov site

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:


Ciclesonide Anti-Allergic Agents Glucocorticoids Hormones	Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

Small Particle Steroids in Refractory Asthma (SPIRA)