Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)

This study has been completed.

First Received: September 12, 2005 Last Updated: July 17, 2008 History of Changes

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163358

Purpose

The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 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	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Ciclesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-Term Asthma Control

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

time until the first severe asthma exacerbation occurs
number of poorly controlled asthma days.

Secondary Outcome Measures:

percentage of days with asthma control
percentage of days with asthma symptoms
percentage of nocturnal awakenings due to asthma
asthma symptom score
number of inhalations of rescue medication
proportion of patients with severe asthma exacerbations
differences in morning PEF from diary
differences in FEV1 and FVC from spirometry
blood eosinophils
AQLQ(S)
health economic data
vital signs
laboratory work-up
adverse events.

Estimated Enrollment:	630
Study Start Date:	September 2003

Eligibility

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

Criteria

Main Inclusion Criteria:

Clinical diagnosis of mild persistent asthma
Pre-treatment with SABAs only
FEV1 ≥80% predicted
Good health with the exception of asthma

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 pulmonary function
Pregnancy
Intention to become pregnant during the course of the study
Breast feeding
Lack of safe contraception
Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163358

Show 111 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Chair:	Paul O'Byrne, Prof.	McMaster University in Hamilton, Ontario, Canada
Study Chair:	Søren Pedersen, Prof.	University of Odense, Kolding, Denmark
Study Chair:	D.S. Postma, Prof.	University Hospital of Groningen, The Netherlands

More Information

No publications provided

Study ID Numbers:	BY9010/M1-132
Study First Received:	September 12, 2005
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00163358 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Fluticasone propionate
Salmeterol

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Bronchial Diseases
Adrenergic Agents
Adrenergic beta-Agonists
Ciclesonide
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents

Adrenergic Agonists
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
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Ciclesonide
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone

Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 06, 2009