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) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 12, 2005

Last Updated Date

July 17, 2008

Start Date ^†

September 2003

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

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

Change History

Complete list of historical versions of study NCT00163358 on ClinicalTrials.gov Archive Site

Current 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.

Original 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.

Descriptive Information

Brief Title ^†

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)

Official Title ^†

Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-Term Asthma Control

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Asthma

Intervention ^†

Drug: Ciclesonide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

630

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

12 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Australia, Canada, Czech Republic, Hungary, Poland, South Africa, Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00163358

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

ALTANA Pharma

Collaborators ^††

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

Information Provided By

ALTANA Pharma

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.