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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163449
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 8, 2016
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
Study Start Date : November 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide

Arm Intervention/treatment
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
Drug: Placebo

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

Secondary Outcome Measures :
  1. rate of patients with moderate or severe asthma exacerbation [ Time Frame: 24 weeks ]
  2. rate of patients with moderate asthma exacerbation [ Time Frame: 24 weeks ]
  3. rate of patients with severe asthma exacerbation [ Time Frame: 24 weeks ]
  4. time to first moderate asthma exacerbation [ Time Frame: 24 weeks ]
  5. time to first severe asthma exacerbation [ Time Frame: 24 weeks ]
  6. asthma symptom score from diary [ Time Frame: 24 weeks ]
  7. use of rescue medication [ Time Frame: 24 weeks ]
  8. patient perceived asthma control [ Time Frame: 24 weeks ]
  9. quality of life data (PACQLQ) [ Time Frame: 24 weeks ]
  10. morning and evening PEF from diary [ Time Frame: 24 weeks ]
  11. pulmonary function variables measured at the investigational sites [ Time Frame: 24 weeks ]
  12. adverse events [ Time Frame: 24 weeks ]
  13. physical examination [ Time Frame: 24 weeks ]
  14. vital signs [ Time Frame: 24 weeks ]
  15. laboratory work-up [ Time Frame: 24 weeks ]
  16. serum cortisol [ Time Frame: 24 weeks ]
  17. urine cortisol variables [ Time Frame: 24 weeks ]
  18. body growth determined by stadiometry. [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00163449

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Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00163449     History of Changes
Other Study ID Numbers: BY9010/M1-207
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 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