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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Ciclesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00163293

U1111-1189-7814 (Registry Identifier)

BY9010/CA-101

2007-003736-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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

Main 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Ciclesonide 100 µg

Active Comparator group

Description:

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

Treatment:

Drug: Ciclesonide

Ciclesonide 200 µg

Active Comparator group

Description:

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

Treatment:

Drug: Ciclesonide