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

November 29, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Altana Pharma/Nycomed
      • Chungbuk, Korea, Republic of, 361-711
        • Altana Pharma/Nycomed
      • Chungnam, Korea, Republic of, 330-715
        • Altana Pharma/Nycomed
      • Daegu, Korea, Republic of, 700-712
        • Altana Pharma/Nycomed
      • Daegu, Korea, Republic of, 700-721
        • Altana Pharma/Nycomed
      • Daejeon, Korea, Republic of, 301-721
        • Altana Pharma/Nycomed
      • Gangwon-do, Korea, Republic of, 220-701
        • Altana Pharma/Nycomed
      • Gwangju, Korea, Republic of, 501-757
        • Altana Pharma/Nycomed
      • Gyeonggi-do, Korea, Republic of, 420-767
        • Altana Pharma/Nycomed
      • Gyeonggi-do, Korea, Republic of, 442-721
        • Altana Pharma/Nycomed
      • Jeonju, Korea, Republic of, 561-712
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 135-710
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 138-736
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 137-701
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 140-757
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 158-710
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 120-749
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 133-792
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 134-701
        • Altana Pharma/Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
FEV1 absolute values.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY9010/M1-136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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