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

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: NCT00163397
• Other study ID #: BY9010/M1-137
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 29, 2016
• Start date: January 2004
• Est. completion date: July 2005

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2005
• Est. primary completion date: July 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 (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

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
Malaysia	Altana Pharma/Nycomed	Kota Bharu / Kelantan
Malaysia	Altana Pharma/Nycomed	Kuala Lumpur
Malaysia	Altana Pharma/Nycomed	Kuala Lumpur
Malaysia	Altana Pharma/Nycomed	Kuala Lumpur
Taiwan	Altana Pharma/Nycomed	Taipei
Taiwan	Altana Pharma/Nycomed	Taipei City 114

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Malaysia,  Taiwan, 

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)
Secondary	physical examination
Secondary	vital signs
Secondary	laboratory work-up
Secondary	adverse events.

External Links

•   BY9010-M1-137-RDS-2006-12-03.pdf