NCT00163371

Brief Summary

The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Sep 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

September 12, 2005

Last Update Submit

November 30, 2016

Conditions

Asthma

Keywords

AsthmaCiclesonideChildFluticasone propionateHPA-axisPediatricLinear growth rate

Outcome Measures

Primary Outcomes (1)

  • growth velocity of the right lower leg as measured by knemometry.

Secondary Outcomes (8)

  • HPA-axis function

  • weight and height

  • lung function from spirometry

  • asthma symptom score, use of rescue medication from diary

  • adverse events

  • +3 more secondary outcomes

Interventions

CiclesonideDRUG

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
  • Prepubertal stage
  • Good health with the exception of asthma
  • History of asthma for at least 6 months
  • Currently using rescue medication only

You may not qualify if:

  • Childbearing potential (beyond menarche)
  • Concurrent diseases or conditions which may subsequently affect growth
  • COPD or relevant lung diseases causing alternating impairment in lung function
  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • History of life-threatening asthma
  • Current smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altana Pharma/Nycomed

Kolding, 6000, Denmark

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

September 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 1, 2016

Record last verified: 2016-10

Locations

DK(1)