Clinical trial NCT00163293: Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
Official title: Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Exacerbation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 240
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to First Asthma Exacerbation
timeFrame: Up to 12 months
measure: Exacerbations (Post-hoc Analysis of Annual Rates)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Growth Velocity as Assessed by Stadiometric Height Measurement
timeFrame: Up to 12 months
measure: Mean Rate of Asthma Exacerbations Per Year
timeFrame: Up to 12 months
measure: Duration of Exacerbations
timeFrame: Up to 12 months
measure: Number of Exacerbations Per Participant
timeFrame: Up to 12 months
measure: Percentage of Participants Who Dropped-out Due to Asthma Exacerbation
timeFrame: Up to 12 months
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)
timeFrame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)
timeFrame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12
measure: Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries
timeFrame: Months 1, 2, 4, 6, 8, 10 and 12
measure: Change From Baseline in PEF by Diary Entries
timeFrame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12
measure: Change From Baseline in Diurnal PEF Fluctuation
timeFrame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12
measure: Total Asthma Symptom Score by Diary Entries
timeFrame: Months 1, 2, 4, 6, 8, 10 and 12
measure: Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms
timeFrame: Months 1, 2, 4, 6, 8, 10 and 12
measure: Rescue Medication Use Per Day
timeFrame: Months 1, 2, 4, 6, 8, 10 and 12
measure: Percentage of Rescue Medication Free Days
timeFrame: Months 1, 2, 4, 6, 8, 10 and 12
measure: Percentage of Asthma Symptom Free Days
timeFrame: Months 1, 2, 4, 6, 8, 10 and 12
measure: Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])
timeFrame: Months 2, 6 and 12
measure: Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
timeFrame: Months 2, 6 and 12
measure: Number of Participants With Clinically Significant Vital Signs Findings
timeFrame: Up to 12 months
measure: Number of Participants With Clinically Significant Physical Examination Findings
timeFrame: Up to 12 months
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: Up to 12 months
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Altana Pharma/Nycomed
city: Fleurimont
country: Canada
facility: Altana Pharma/Nycomed
city: London,ON
country: Canada
facility: Altana Pharma/Nycomed
city: London
country: Canada
facility: Altana Pharma/Nycomed
city: Winnipeg
country: Canada
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Kapstadt
country: South Africa
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: