Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00163449
First received: September 12, 2005
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • time to first moderate or severe asthma exacerbation. [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • rate of patients with moderate or severe asthma exacerbation [ Time Frame: 24 weeks ]
  • rate of patients with moderate asthma exacerbation [ Time Frame: 24 weeks ]
  • rate of patients with severe asthma exacerbation [ Time Frame: 24 weeks ]
  • time to first moderate asthma exacerbation [ Time Frame: 24 weeks ]
  • time to first severe asthma exacerbation [ Time Frame: 24 weeks ]
  • asthma symptom score from diary [ Time Frame: 24 weeks ]
  • use of rescue medication [ Time Frame: 24 weeks ]
  • patient perceived asthma control [ Time Frame: 24 weeks ]
  • quality of life data (PACQLQ) [ Time Frame: 24 weeks ]
  • morning and evening PEF from diary [ Time Frame: 24 weeks ]
  • pulmonary function variables measured at the investigational sites [ Time Frame: 24 weeks ]
  • adverse events [ Time Frame: 24 weeks ]
  • physical examination [ Time Frame: 24 weeks ]
  • vital signs [ Time Frame: 24 weeks ]
  • laboratory work-up [ Time Frame: 24 weeks ]
  • serum cortisol [ Time Frame: 24 weeks ]
  • urine cortisol variables [ Time Frame: 24 weeks ]
  • body growth determined by stadiometry. [ Time Frame: 24 weeks ]

Estimated Enrollment: 1000
Study Start Date: November 2005
Study Completion Date: May 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ciclesonide 40 µg
Drug: Ciclesonide
Efficacy and Safety of Ciclesonide
Active Comparator: 2
Ciclesonide 80 µg
Drug: Ciclesonide
Efficacy and Safety of Ciclesonide
Active Comparator: 3
Ciclesonide 160 µg
Drug: Ciclesonide
Efficacy and Safety of Ciclesonide
Placebo Comparator: 4
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Written informed consent by the parents or legal guardians of the patient
  • Outpatients
  • Good health with the exception of asthma
  • Documented diagnosis of asthma for more than 6 months
  • Use of rescue medication only or pretreatment with a controller drug

Main Exclusion Criteria:

  • Concomitant severe diseases
  • Diseases contraindicated for the use of inhaled steroids
  • Other relevant lung diseases causing impairment in pulmonary function
  • Recurrent, episodic wheezing only
  • History of life-threatening asthma
  • History of any mechanical ventilation
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
  • Premature birth (< 32 weeks gestation)
  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: NCT00163449

  Show 96 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163449     History of Changes
Other Study ID Numbers: BY9010/M1-207 
Study First Received: September 12, 2005
Last Updated: December 7, 2016

Keywords provided by AstraZeneca:
Asthma
Ciclesonide
Child
Pediatric

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
Anti-Allergic Agents

ClinicalTrials.gov processed this record on January 19, 2017