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 on September 12, 2005. Last Updated on July 17, 2008 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-Term Asthma Control

Resource links provided by NLM:

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

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 by ALTANA Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Postma DS, O'Byrne PM, Pedersen S. Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control. Chest. 2011 Feb;139(2):311-8. Epub 2010 Nov 18.

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

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Fluticasone propionate
Salmeterol

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Ciclesonide
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012