Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)

Asthma Clinical Trial

Official title:

Effect of Ciclesonide (320 mcg/Day) vs Fluticasone Propionate (375 mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163371
• Other study ID #: BY9010/M1-208
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 30, 2016
• Start date: September 2005
• Est. completion date: December 2005

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Main Inclusion Criteria:

• 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

Main Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide

Locations

Country	Name	City	State
Denmark	Altana Pharma/Nycomed	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	growth velocity of the right lower leg as measured by knemometry.
Secondary	HPA-axis function
Secondary	weight and height
Secondary	lung function from spirometry
Secondary	asthma symptom score, use of rescue medication from diary
Secondary	adverse events
Secondary	vital signs, including blood pressure, pulse rate
Secondary	physical examination
Secondary	laboratory investigation.

External Links

•   BY9010-MI-208-RDS-2007-04-11.pdf