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

NCT ID: NCT00163293

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-01
• Study Completion Date: 2010-04-01

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.

Detailed Description

The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat children who have mild asthma.

The study enrolled 240 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

• Ciclesonide 100 µg
• Ciclesonide 200 µg
• Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the study drug but has no active ingredient.

All participants were asked to take two puffs from a metered-dose inhaler once daily, in the evening, for up to 12 months.

This multi-center trial was conducted in Canada, Hungary and South Africa. The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks. Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Ciclesonide placebo-matching metered-dose inhaler

Ciclesonide 100 µg

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

Group Type: ACTIVE_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Ciclesonide metered-dose inhaler

Ciclesonide 200 µg

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

Group Type: ACTIVE_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Ciclesonide metered-dose inhaler

Interventions

Ciclesonide

Ciclesonide metered-dose inhaler

Intervention Type: DRUG

Placebo

Ciclesonide placebo-matching metered-dose inhaler

Intervention Type: DRUG

Other Intervention Names

Alvesco®

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Altana Pharma/Nycomed

Calgary, , Canada

Altana Pharma/Nycomed

Fleurimont, , Canada

Altana Pharma/Nycomed

London, , Canada

Altana Pharma/Nycomed

London,ON, , Canada

Altana Pharma/Nycomed

Winnipeg, , Canada

Altana Pharma/Nycomed

Budapest, , Hungary

Altana Pharma/Nycomed

Cape Town, , South Africa

Countries

Canada; Hungary; South Africa

Other Identifiers

2007-003736-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1189-7814

Identifier Type: REGISTRY

Identifier Source: secondary_id

BY9010/CA-101

Identifier Type: -

Identifier Source: org_study_id