Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00163384

Collaborator

(none)

240

Enrollment

Locations

Duration (Months)

12.6

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will compare the effectiveness of one dose of ciclesonide against one dose of budesonide in patients with asthma.

The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset of action and the safety and tolerability of ciclesonide in comparison to budesonide will also be investigated.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Ciclesonide	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

FEV1 absolute values. []

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 (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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Altana Pharma/Nycomed	Busan	Korea, Republic of	602-715
2	Altana Pharma/Nycomed	Chungbuk	Korea, Republic of	361-711
3	Altana Pharma/Nycomed	Chungnam	Korea, Republic of	330-715
4	Altana Pharma/Nycomed	Daegu	Korea, Republic of	700-712
5	Altana Pharma/Nycomed	Daegu	Korea, Republic of	700-721
6	Altana Pharma/Nycomed	Daejeon	Korea, Republic of	301-721
7	Altana Pharma/Nycomed	Gangwon-do	Korea, Republic of	220-701
8	Altana Pharma/Nycomed	Gwangju	Korea, Republic of	501-757
9	Altana Pharma/Nycomed	Gyeonggi-do	Korea, Republic of	420-767
10	Altana Pharma/Nycomed	Gyeonggi-do	Korea, Republic of	442-721
11	Altana Pharma/Nycomed	Jeonju	Korea, Republic of	561-712
12	Altana Pharma/Nycomed	Seoul	Korea, Republic of	120-749
13	Altana Pharma/Nycomed	Seoul	Korea, Republic of	133-792
14	Altana Pharma/Nycomed	Seoul	Korea, Republic of	134-701
15	Altana Pharma/Nycomed	Seoul	Korea, Republic of	135-710
16	Altana Pharma/Nycomed	Seoul	Korea, Republic of	137-701
17	Altana Pharma/Nycomed	Seoul	Korea, Republic of	138-736
18	Altana Pharma/Nycomed	Seoul	Korea, Republic of	140-757
19	Altana Pharma/Nycomed	Seoul	Korea, Republic of	158-710