NCT01171365

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

3.8 years

First QC Date

June 24, 2010

Last Update Submit

January 30, 2014

Conditions

Asthma

Keywords

CiclesonideAsthmaTherapeutic UsesPulmonary EosinophiliaNitric OxideLung DiseasesRespiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (7)

  • Change in alveolar nitric oxide level over the trial period

    0 weeks (start), 4 weeks, 8 weeks (finish)

  • Change in bronchial nitric oxide level

    0 weeks (start), 4 weeks, 8 weeks (finish)

  • Change in prebronchodilator FEV1

    0 weeks (start), 4 weeks, 8 weeks (finish)

  • Change in Juniper Asthma Control Questionnaire (ACQ) score

    0 weeks (start), 4 weeks, 8 weeks (finish)

  • Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score

    0 weeks (start), 4 weeks, 8 weeks (finish)

  • +2 more secondary outcomes

Study Arms (2)

Ciclesonide

ACTIVE COMPARATOR

Ciclesonide 320 microgrammes twice daily

Drug: Ciclesonide

Placebo

PLACEBO COMPARATOR

Placebo 2 inhalations twice daily

Drug: Placebo

Interventions

CiclesonideDRUG

Inhaled ciclesonide 320mcg twice daily

Also known as: Alvesco
Ciclesonide
PlaceboDRUG

Matched placebo inhaler two inhalations twice daily

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25858909DERIVED

MeSH Terms

Conditions

AsthmaPulmonary EosinophiliaLung DiseasesRespiratory Tract Diseases

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Tim Harrison

    University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Ian Pavord

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2010

First Posted

July 28, 2010

Study Start

January 1, 2010

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

GB(2)