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.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163293
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: January 2011
  Purpose

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
Asthma
Drug: Ciclesonide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 Takeda:

Primary Outcome Measures:
  • Time to First Exacerbation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Standing height measured in millimeters with a wall-mounted stadiometer

  • Mean Rate of Asthma Exacerbations Per Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Duration of Exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Drop-out Rate Due to Asthma Exacerbation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in FEV1 as Percent Predicted and Absolute Values [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Morning and Evening PEF Measurements by Diary Entries [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Variation in PEF by Diary Entries [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Diurnal PEF Fluctuation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Total Symptom Score by Diary Entries [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent Nights With Nocturnal Awakenings Due to Asthma Symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rescue Medication Use by Diary Entries [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Rescue Medication Free Days by Diary Entries [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Quality of Life Assessments as Per Pediatric Asthma Quality of Life Questionnaires PAQLQ(S) and PACQLQ [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physical Examination and Vital Signs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Laboratory Work-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00163293

Locations
Canada
Altana Pharma/Nycomed
Calgary, Canada, T2T5C7
Altana Pharma/Nycomed
Fleurimont, Canada, J1H 5M4
Altana Pharma/Nycomed
London, Canada, N6C 4Y7
Altana Pharma/Nycomed
London,ON, Canada, N6A1V2
Altana Pharma/Nycomed
Winnipeg, Canada, R3A1R9
Hungary
Altana Pharma/Nycomed
Budapest, Hungary
South Africa
Altana Pharma/Nycomed
Kapstadt, South Africa
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Allan Becker, Dr Children's Hospital, Winnipeg, Manitoba, Canada
  More Information

No publications provided

Responsible Party: Nycomed GmbH, Nycomed
ClinicalTrials.gov 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: May 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Takeda:
Asthma
Ciclesonide
Exacerbation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014