NCT00546520

Brief Summary

Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and induced sputum inflammatory biomarkers will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

1 active site

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

April 1, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

October 18, 2007

Last Update Submit

December 5, 2016

Conditions

Asthma

Keywords

AsthmaCiclesonideAirway hyperresponsivenessSputumNitric oxide

Outcome Measures

Primary Outcomes (1)

  • PC20FEV1 (AMP)

Secondary Outcomes (1)

  • Baseline FEV1 from spirometry, exhaled NO, eosinophils, basophils, and mast cells determined from induced sputum; Safety variables: Physical examination, vital signs, ECG, laboratory work-up, and adverse events

Interventions

CiclesonideDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Out-patients
  • Written informed consent
  • History of atopic disease
  • History of perennial bronchial asthma for at least 6 months as defined by ATS criteria
  • Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0)
  • Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
  • FEV1 ≥ 70% predicted
  • Hyperreactivity to AMP (PC20FEV1 \< 25 mg/ml)
  • Good health with the exception of asthma
  • Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence

You may not qualify if:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
  • Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
  • Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
  • Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
  • Immunotherapy within one month prior to B0 and/or during the entire study duration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Altana Pharma/Nycomed"

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

AsthmaRespiratory Hypersensitivity

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 19, 2007

Study Start

April 1, 2002

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

GB(1)