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)

AstraZeneca28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

CiclesonideDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

HPA-axis function

weight and height

lung function from spirometry

asthma symptom score, use of rescue medication from diary

adverse events

vital signs, including blood pressure, pulse rate

physical examination

laboratory investigation.