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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 12, 2005
Last updated: December 2, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Drug: Ciclesonide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to First Exacerbation [ Time Frame: 12 months ]
    Basis was the Intention to Treat Population (ITT). Time to first exacerbation is defined as the time until the first asthma exacerbation, or to end of T12 visit (=last visit).

  • Exacerbations (Post-hoc Analysis of Annual Rates) [ Time Frame: 12 months ]
    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 [yrs] and race were identified to be important beside treatment. The parameters centre and age [yrs] 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.

Secondary Outcome Measures:
  • Growth Velocity as Assessed by Stadiometric Height Measurement [ Time Frame: 12 months ]
    Standing height measured in millimeters with a wall-mounted stadiometer

  • Mean Rate of Asthma Exacerbations Per Year [ Time Frame: 12 months ]
  • Duration of Exacerbations [ Time Frame: 12 months ]
  • Number of Exacerbations [ Time Frame: 12 months ]
  • Drop-out Rate Due to Asthma Exacerbation [ Time Frame: 12 months ]
  • Change in FEV1 as Percent Predicted and Absolute Values [ Time Frame: 12 months ]
  • Morning and Evening PEF Measurements by Diary Entries [ Time Frame: 12 months ]
  • Variation in PEF by Diary Entries [ Time Frame: 12 months ]
  • Diurnal PEF Fluctuation [ Time Frame: 12 months ]
  • Total Symptom Score by Diary Entries [ Time Frame: 12 months ]
  • Percent Nights With Nocturnal Awakenings Due to Asthma Symptoms [ Time Frame: 12 months ]
  • Rescue Medication Use by Diary Entries [ Time Frame: 12 months ]
  • Number of Rescue Medication Free Days by Diary Entries [ Time Frame: 12 months ]
    The number of rescue medication free days is the number of days during which the total puffs of rescue medication (salbutamol) use is 0. Assessment during baseline period at visit B2, B3 and B4 and during treatment period at visit T1, T2, T4, T6, T8, T10 and T12/Tend.

  • Number of Symptom Free Days by Diary Entries [ Time Frame: 12 months ]
  • Quality of Life Assessments as Per Pediatric Asthma Quality of Life Questionnaires PAQLQ(S) and PACQLQ [ Time Frame: 12 months ]
  • Physical Examination and Vital Signs [ Time Frame: 12 months ]
  • Laboratory Work-up. [ Time Frame: 12 months ]

Enrollment: 240
Study Start Date: January 2005
Study Completion Date: April 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CIC 100
Ciclesonide 100µg
Drug: Ciclesonide
100µg, two puffs once daily, in the evening
Active Comparator: CIC 200
Ciclesonide 200µg
Drug: Ciclesonide
200µg, two puffs once daily, in the evening
Placebo Comparator: Placebo Drug: Placebo
two puffs once daily, in the evening


Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • Outpatients
  • Symptoms consistent with the diagnosis of asthma for at least 12 months
  • FEV1 at least 80% of predicted
  • Patients 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
  • Patients 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00163293

Altana Pharma/Nycomed
Calgary, Canada, T2T5C7
Altana Pharma/Nycomed
Fleurimont, Canada, J1H 5M4
Altana Pharma/Nycomed
London,ON, Canada, N6A1V2
Altana Pharma/Nycomed
London, Canada, N6C 4Y7
Altana Pharma/Nycomed
Winnipeg, Canada, R3A1R9
Altana Pharma/Nycomed
Budapest, Hungary
South Africa
Altana Pharma/Nycomed
Kapstadt, South Africa
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Responsible Party: AstraZeneca Identifier: NCT00163293     History of Changes
Other Study ID Numbers: BY9010/CA-101
Study First Received: September 12, 2005
Results First Received: December 1, 2010
Last Updated: December 2, 2016

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents processed this record on March 23, 2017