NCT00163332

Brief Summary

The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3 asthma

Geographic Reach
1 country

5 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

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

December 6, 2016

Status Verified

September 1, 2016

First QC Date

September 12, 2005

Last Update Submit

December 2, 2016

Conditions

Asthma

Keywords

AsthmaCiclesonideFluticasone propionate

Outcome Measures

Primary Outcomes (2)

  • AUC(0-24h)/24 h of serum cortisol level

  • 24 h urinary cortisol excretion adjusted for creatinine.

Secondary Outcomes (6)

  • 8 am measurement of bone formation markers

  • PC20FEV1 to methacholine

  • PC20FEV1 to AMP

  • lung function (FEV1, FVC)

  • pharmacokinetics

  • +1 more secondary outcomes

Interventions

CiclesonideDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients who have had a history of bronchial asthma for at least 6 months
  • FEV1 \>60% of predicted for at least 24 h
  • Patients who are hyperresponsive to methacholine and to AMP
  • Patients who are in good health with the exception of asthma

You may not qualify if:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • Patients suffering from COPD and/or other relevant lung diseases except asthma
  • Current smokers and ex-smokers both with ≥10 pack years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Altana Pharma/Nycomed

Genk, 3600, Belgium

Location

Altana Pharma/Nycomed

Ghent, 9000, Belgium

Location

Altana Pharma/Nycomed

Lanaken, 3620, Belgium

Location

Altana Pharma/Nycomed

Liège, 4000, Belgium

Location

Altana Pharma/Nycomed

Liége, 4000, Belgium

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

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

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

March 1, 2003

Last Updated

December 6, 2016

Record last verified: 2016-09

Locations

BE(5)