Skip to main content
OpenTrials
Completed

NCT Number: NCT00163449

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Campinas - SP, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ciclesonide

Drug

Efficacy and Safety of Ciclesonide

Placebo

Drug

Placebo

Primary outcomes

  1. time to first moderate or severe asthma exacerbation.

    Time frame: 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Sep 14, 2005
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.