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

Asthma Clinical Trial

Official title:

A Phase III, Multicenter, Double-Blind, Placebo Controlled, Non-Inferiority Study Assessing the Effects of Ciclesonide Metered Dose Inhaler 50 Mg/Day and 200 Mg/Day (Ex-Valve) Administered Once Daily on Growth in Children With Mild Persistent Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270348
• Other study ID #: LTS6159
• Secondary ID: XRP1526B - 343
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: December 27, 2005
• Start date: December 2000
• Est. completion date: September 2004

Study information

• Verified date: December 2005
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 102 Months

Eligibility

Inclusion Criteria:

• Females between 5 and 7.5 years and male between 5 and 8.5 years of age with normal heights, a history of mild persistent asthma for at least 3 months prior to visit 1, a forced expiratory volume in one second (FEV1) of ³80% of predicted following at least a 4-hour albuterol withhold, and treated with non-corticosteroid asthma medications on an as-needed or daily basis, or with low doses of inhaled corticosteroids (ICSs) for at least one month prior to Visit 1. Subjects were to be no greater than Stage 1 in the Tanner classification of sexual maturity, and they had to be able to demonstrate effective use of the MDI devices and perform reproducible pulmonary function test.

Exclusion Criteria:

• Subjects with a history of life-threatening asthma, severe respiratory impairment, history of abnormal growth, concurrent disease or condition which may substantially affect growth, previous requirement for daily or alternate day oral corticosteroids (OCS) treatment for ³60 days within the 2 years of Visit 3 and/or any use of OCS within 30 days prior to Visit 1 or during the run-in period, previous treatment with moderate or high doses of inhaled corticosteroid during the 30 days prior to Visit 1

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ciclesonide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject’s height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject’s stadiometer height data
Secondary	Blinded assessment of bone age according to Greulich and Pyle radiographic atlas with wrist X-rays. Subjects monitored for AEs and any events occurring during study. Pulmonary function tests performed to measure FEV1 in liters and % of predicted FEV1