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

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163449

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 III

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-School Asthma Patients

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

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
1: Active Comparator Ciclesonide 40 µg	Drug: Ciclesonide Efficacy and Safety of Ciclesonide
2: Active Comparator Ciclesonide 80 µg	Drug: Ciclesonide Efficacy and Safety of Ciclesonide
3: Active Comparator Ciclesonide 160 µg	Drug: Ciclesonide Efficacy and Safety of Ciclesonide
4: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163449

Show 96 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Paul Brand, Dr

Isala Klinieken, Zwolle, The Netherlands

More Information

No publications provided

Responsible Party:	Nycomed ( Nycomed GmbH )
Study ID Numbers:	BY9010/M1-207
Study First Received:	September 12, 2005
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00163449 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Child
Pediatric

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Ciclesonide

Lung Diseases
Hypersensitivity, Immediate
Asthma
Anti-Allergic Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Bronchial Diseases
Immune System Diseases
Ciclesonide
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009