Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

This study has been completed.

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

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163423

Purpose

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate 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 (24 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, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Ciclesonide (80 Mcg Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily) in Patients With Mild to Moderate 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
time to the first asthma exacerbation.

Secondary Outcome Measures:

FVC
asthma symptom score
use of rescue medication
AQLQ(S) and EQ-5D
percentage of days on which patients perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
physical examination
vital signs
standard laboratory work-up
adverse events
number of patients with local oropharyngeal adverse events.

Estimated Enrollment:	480
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Outpatients
Written informed consent
History of bronchial asthma for at least 6 months
Good health with the exception of asthma
Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
FEV1 80 - 105% of predicted

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
Current smoking with more than 10 pack-years
Previous smoking with more than 10 pack-years
Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
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: NCT00163423

Show 51 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Ronald Dahl, Prof.

Aarhus University Hospital, Aarhus, Denmark

More Information

No publications provided

Study ID Numbers:	BY9010/M1-142
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163423 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Fluticasone propionate

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bronchial Diseases
Ciclesonide
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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 September 11, 2009