A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma (6-11 y) (BY9010/M1-209) - Full Text View

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00384189

Purpose

The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma

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:

lung function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

asthma symptoms and lung function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1050
Study Start Date:	October 2006
Study Completion Date:	June 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ciclesonide 40µg	Drug: Ciclesonide inhaled Ciclesonide
2: Active Comparator Ciclesonide 80µg	Drug: Ciclesonide inhaled Ciclesonide
3: Active Comparator 160µg	Drug: Ciclesonide inhaled Ciclesonide
4: Placebo Comparator Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

History of asthma for at least 6 months
Ability to show optimal use of MDI, including inhalation technique
Lung function and reversibility within specified limits

Main Exclusion Criteria:

Concomitant severe diseases
Diseases which are contraindications for the use of inhaled steroids
Two or more inpatient hospitalizations for asthma within the last year
Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks)
Beginning of or change in immunotherapy within the last 6 months prior to inclusion
Inability to follow the procedures of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384189

Show 123 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Søren Pedersen, Prof.

Odense University Hospital, Kolding, Denmark

More Information

No publications provided

Responsible Party:	Nycomed ( Nycomed GmbH )
Study ID Numbers:	BY9010/M1-209
Study First Received:	October 4, 2006
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00384189 History of Changes
Health Authority:	South Africa: Medicines Control Council

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
children

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 03, 2009