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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163384
• Other study ID #: BY9010/M1-136
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 29, 2016
• Start date: January 2004
• Est. completion date: May 2005

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide

Locations

Country	Name	City	State
Korea, Republic of	Altana Pharma/Nycomed	Busan
Korea, Republic of	Altana Pharma/Nycomed	Chungbuk
Korea, Republic of	Altana Pharma/Nycomed	Chungnam
Korea, Republic of	Altana Pharma/Nycomed	Daegu
Korea, Republic of	Altana Pharma/Nycomed	Daegu
Korea, Republic of	Altana Pharma/Nycomed	Daejeon
Korea, Republic of	Altana Pharma/Nycomed	Gangwon-do
Korea, Republic of	Altana Pharma/Nycomed	Gwangju
Korea, Republic of	Altana Pharma/Nycomed	Gyeonggi-do
Korea, Republic of	Altana Pharma/Nycomed	Gyeonggi-do
Korea, Republic of	Altana Pharma/Nycomed	Jeonju
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 absolute values.
Secondary	FEV1 as percent of predicted
Secondary	FVC
Secondary	PEF absolute values
Secondary	morning and evening PEF from diary
Secondary	diurnal PEF fluctuation
Secondary	asthma symptom score from diary
Secondary	use of rescue medication from diary
Secondary	number of symptom free- and rescue medication free days
Secondary	dropout rate due to asthma exacerbations
Secondary	time until first asthma exacerbation
Secondary	number of days with asthma control
Secondary	onset of effect
Secondary	subgroup analysis for ex/current smokers and non-smokers
Secondary	AQLQ(S).

External Links

•   BY9010-M1-136-RDS-2006-12-03.pdf