Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137) - 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 16, 2008

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

FEV1 absolute values.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00163397 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

FEV1 as percent of predicted
FVC
PEF absolute values
morning and evening PEF from diary
diurnal PEF fluctuation
asthma symptom score from diary
use of rescue medication from diary
number of symptom free- and rescue medication free days
dropout rate due to asthma exacerbations
time until first asthma exacerbation
number of days with asthma control
onset of effect
subgroup analysis for ex/current smokers and non-smokers
AQLQ(S)
physical examination
vital signs
laboratory work-up
adverse events.

Original Secondary Outcome Measures ^†

FEV1 as percent of predicted
FVC
PEF absolute values
morning and evening PEF from diary
diurnal PEF fluctuation
asthma symptom score from diary
use of rescue medication from diary
number of symptom free- and rescue medication free days
dropout rate due to asthma exacerbations
time until first asthma exacerbation
number of days with asthma control
onset of effect
subgroup analysis for ex/current smokers and non-smokers
AQLQ(S)
physical examination
vital signs
laboratory work-up
adverse events.

Descriptive Information

Brief Title ^†

Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)

Official Title ^†

A Comparative Study of Inhaled Ciclesonide 160 Mcg/Day vs Budesonide 400 Mcg/Day in Patients With Asthma

Brief Summary

The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 weeks). 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, Active 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 ^†

120

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Main Inclusion Criteria:

During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
FEV1 80 - 105% of predicted
Healthy with the exception of asthma
Written informed consent has been obtained
Outpatients
Patients who have a history of persistent bronchial asthma for at least 6 months

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
Pregnancy
Intention to become pregnant during the course of the study
Breast feeding
Lack of safe contraception
Patient is current smoker with 10 or more pack-years
Patient is ex-smoker with 10 or more pack-years

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Malaysia, Taiwan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00163397

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

ALTANA Pharma

Collaborators ^††

Investigators ^†

Study Chair:	Jeyaindran Sinnadurai, MD	Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
Study Chair:	Reury-Perng Perng, MD	Veterans General Hospital, Taipei, Taiwan

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.