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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:
Takeda
ClinicalTrials.gov Identifier:
NCT00163449
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: December 2008
  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
Endpoint Classification: Safety/Efficacy Study
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 Takeda:

Primary Outcome Measures:
  • time to first moderate or severe asthma exacerbation. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of patients with moderate or severe asthma exacerbation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • rate of patients with moderate asthma exacerbation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • rate of patients with severe asthma exacerbation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • time to first moderate asthma exacerbation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • time to first severe asthma exacerbation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • asthma symptom score from diary [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • use of rescue medication [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • patient perceived asthma control [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • quality of life data (PACQLQ) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • morning and evening PEF from diary [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • pulmonary function variables measured at the investigational sites [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • physical examination [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • vital signs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • laboratory work-up [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • serum cortisol [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • urine cortisol variables [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • body growth determined by stadiometry. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
Takeda
Investigators
Principal Investigator: Paul Brand, Dr Isala Klinieken, Zwolle, The Netherlands
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed GmbH, Nycomed
ClinicalTrials.gov Identifier: NCT00163449     History of Changes
Other Study ID Numbers: BY9010/M1-207
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:
Asthma
Ciclesonide
Child
Pediatric

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

ClinicalTrials.gov processed this record on November 25, 2014