Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)

NCT00163293 | Completed Phase 3 Results

• 3 other identifiers: BY9010/CA-1012007-003736-34U1111-1189-7814
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 7

Brief Summary

The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.

Conditions

Asthma

Keywords

Asthma; Ciclesonide; Exacerbation

Outcome Measures

Primary Outcomes (2)

• Time to First Asthma Exacerbation

  Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.

  Up to 12 months

• Exacerbations (Post-hoc Analysis of Annual Rates)

  A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age \[years\] and race were identified to be important beside treatment. The parameters centre and age \[years\] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.

  Up to 12 months

Secondary Outcomes (21)

• Growth Velocity as Assessed by Stadiometric Height Measurement

  Up to 12 months

• Mean Rate of Asthma Exacerbations Per Year

  Up to 12 months

• Duration of Exacerbations

  Up to 12 months

• Number of Exacerbations Per Participant

  Up to 12 months

• Percentage of Participants Who Dropped-out Due to Asthma Exacerbation

  Up to 12 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Ciclesonide 100 µg

ACTIVE COMPARATOR

Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

Drug: Ciclesonide

Ciclesonide 200 µg

ACTIVE COMPARATOR

Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

Drug: Ciclesonide

Interventions

Ciclesonide DRUG

Ciclesonide metered-dose inhaler

Also known as: Alvesco®

Ciclesonide 100 µg; Ciclesonide 200 µg

Placebo DRUG

Ciclesonide placebo-matching metered-dose inhaler

Placebo

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Outpatients
• Symptoms consistent with the diagnosis of asthma for at least 12 months
• Forced Expiratory Volume in one Second (FEV) at least 80% of predicted
• Participants who have a history of reversible airway obstruction
• Good health with the exception of asthma

You may not qualify if:

• History of life-threatening asthma
• A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year
• Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
• Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)
• Prematurely born children (\<36 weeks of gestation)
• Smokers
• Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Altana Pharma/Nycomed

Calgary, T2T5C7, Canada

Location

Altana Pharma/Nycomed

Fleurimont, J1H 5M4, Canada

Location

Altana Pharma/Nycomed

London, N6C 4Y7, Canada

Location

Altana Pharma/Nycomed

London,ON, N6A1V2, Canada

Location

Altana Pharma/Nycomed

Winnipeg, R3A1R9, Canada

Location

Altana Pharma/Nycomed

Budapest, Hungary

Location

Altana Pharma/Nycomed

Cape Town, South Africa

Location

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: April 1, 2010
• Last Updated: April 26, 2017
• Results First Posted: December 22, 2010

Record last verified: 2017-03

Locations

ZA (1); HU (1); CA (5)