Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

This study has been completed.

First Received: September 12, 2005 Last Updated: July 16, 2008 History of Changes

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163410

Purpose

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparative Study of Inhaled Ciclesonide 200 Mcg/Day vs Fluticasone Propionate 200 Mcg/Day in Children With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

FEV1 absolute values.

Secondary Outcome Measures:

FEV1 as % of predicted
PEF from spirometry
diary based morning and evening PEF
diary based symptom score
diary based salbutamol MDI use
diurnal PEF fluctuation
drop-out rate due to asthma exacerbations
time until asthma exacerbation
number of symptom free- and rescue medication free days
number of days with asthma control
physical examination
vital signs
laboratory work-up
adverse events.

Estimated Enrollment:	500
Study Start Date:	April 2003

Eligibility

Ages Eligible for Study:	4 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

History of persistent bronchial asthma for at least 6 months
FEV1 50-90% of predicted

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
History of life-threatening asthma
Premature birth
Current smoking
Smoking history with either equal or more than 10 pack-years
Pregnancy
Intention to become pregnant during the course of the study
Breast feeding
Lack of safe contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163410

Locations

India
Altana Pharma/Nycomed
Delhi, India, 110 007
Altana Pharma/Nycomed
Chandigarh, India, 160 012
Altana Pharma/Nycomed
Shastri Nagar, Jaipur, India, 302 016
Altana Pharma/Nycomed
Ahmedabad, India, 380 018
Altana Pharma/Nycomed
Mumbai, India, 400 004
Altana Pharma/Nycomed
Mumbai, India, 400 012
Altana Pharma/Nycomed
Mumbai, India, 400 022
Altana Pharma/Nycomed
Mumbai, India, 400 026
Altana Pharma/Nycomed
Kolkatta, India, 700091
Altana Pharma/Nycomed
Pune, India, 411 030
Altana Pharma/Nycomed
Pune, India, 411 033
Altana Pharma/Nycomed
Bangalore, India, 560 034
Altana Pharma/Nycomed
Coimbatore, India, 641 004
Altana Pharma/Nycomed
Coimbatore, India, 641 014
Altana Pharma/Nycomed
Coimbatore, Tamilnadu, India, 641 044
Altana Pharma/Nycomed
Pune, India, 411 001

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Chair:

Renate Engelstaetter, PhD

ALTANA Pharma, Konstanz, Germany E-mail: info.clintrials@altanapharma.com

More Information

No publications provided

Study ID Numbers:	BY9010/M1-205
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163410 History of Changes
Health Authority:	India: The Drug Controller General of Health Services

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Child
Fluticasone propionate
Pediatric

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Ciclesonide
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009