Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 y) (BY9010/CA-101) - Full Text View

Purpose

The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide Drug: Placebo	Phase III

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Corticosteroids Ciclesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	POPCICLE: Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

time to first exacerbation. [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mean rate of asthma exacerbations per year [ Time Frame: 12 month ] [ Designated as safety issue: No ]
duration of exacerbations [ Time Frame: 12 month ] [ Designated as safety issue: No ]
number of exacerbations [ Time Frame: 12 month ] [ Designated as safety issue: No ]
drop-out rate due to asthma [ Time Frame: 12 month ] [ Designated as safety issue: No ]
change in FEV1 as percent predicted and absolute values [ Time Frame: 12 month ] [ Designated as safety issue: No ]
morning and evening PEF measurements by diary entries [ Time Frame: 12 month ] [ Designated as safety issue: No ]
variation in PEF by diary entries [ Time Frame: 12 month ] [ Designated as safety issue: No ]
diurnal PEF fluctuation [ Time Frame: 12 month ] [ Designated as safety issue: No ]
total symptom score by diary entries [ Time Frame: 12 month ] [ Designated as safety issue: No ]
percent nights with nocturnal awakenings due to asthma symptoms [ Time Frame: 12 month ] [ Designated as safety issue: No ]
rescue medication use by diary entries [ Time Frame: 12 month ] [ Designated as safety issue: No ]
number of rescue medication free days by diary entries [ Time Frame: 12 month ] [ Designated as safety issue: No ]
number of symptom free days by diary entries [ Time Frame: 12 month ] [ Designated as safety issue: No ]
quality of life assessments as per Pediatric Asthma Quality of Life Questionnaires PAQLQ(S) and PACQLQ [ Time Frame: 12 month ] [ Designated as safety issue: No ]
growth velocity as assessed by stadiometric height measurement [ Time Frame: 12 month ] [ Designated as safety issue: No ]
physical examination and vital signs [ Time Frame: 12 month ] [ Designated as safety issue: No ]
laboratory work-up. [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	January 2005
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ciclesonide 100µg	Drug: Ciclesonide Efficacy of Ciclesonide inhaled
2: Active Comparator Ciclesonide 200µg	Drug: Ciclesonide Efficacy of Ciclesonide inhaled
3: Placebo Comparator Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	4 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Outpatients
Symptoms consistent with the diagnosis of asthma for at least 12 months
FEV1 at least 80% of predicted
Patients who have a history of reversible airway obstruction
Good health with the exception of asthma

Main Exclusion Criteria:

History of life-threatening asthma
A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year
Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Patients suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)
Prematurely born children (<36 weeks of gestation)
Smokers
Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163293

Contacts


Contact: Nycomed Clinical Trial Management		clinicaltrials@nycomed.com

Locations


Canada
	Altana Pharma/Nycomed	Recruiting
	Fleurimont, Canada, J1H 5M4
	Altana Pharma/Nycomed	Recruiting
	London,ON, Canada, N6A1V2
	Altana Pharma/Nycomed	Recruiting
	London, Canada, N6C 4Y7
	Altana Pharma/Nycomed	Recruiting
	Winnipeg, Canada, R3A1R9
	Altana Pharma/Nycomed	Recruiting
	Calgary, Canada, T2T5C7

Sponsors and Collaborators

ALTANA Pharma

Investigators


Study Chair:	Allan Becker, Dr	Children's Hospital, Winnipeg, Manitoba, Canada

Study Chair:	Søren Pedersen, Prof.	University of Odense, Kolding, Denmark

More Information

Responsible Party:	Nycomed ( Nycomed GmbH )
Study ID Numbers:	BY9010/CA-101
First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163293
Health Authority:	Canada: Health Canada

Keywords provided by ALTANA Pharma:

Asthma

Ciclesonide

Exacerbation

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Ciclesonide

Lung Diseases

Hypersensitivity, Immediate

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

Bronchial Diseases

Therapeutic Uses

Anti-Allergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163293