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Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent Asthma

NCT00270348 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2005-12-28

No results posted yet for this study

Summary

The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered once daily in the morning is non-inferior to placebo with respect to growth velocity in children with mild persistent asthma following a 12-month treatment period

The secondary objective is to investigate changes in growth in terms of bone age (wrist X-ray), and maintenance of asthma control and safety with ciclesonide

Conditions

Interventions

DRUG

ciclesonide

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
102 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-31
Completion
2004-09-30

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00270348 on ClinicalTrials.gov