Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

December 7, 2016 updated by: AstraZeneca

Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

480

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

  • Austria
      • Gmünd, Austria, 3950
        • Altana Pharma/Nycomed
      • Linz, Austria, 4020
        • Altana Pharma/Nycomed
      • Linz, Austria, 4040
        • Altana Pharma/Nycomed
      • Neusiedl/See, Austria, 7100
        • Altana Pharma/Nycomed
      • Perg, Austria, 4320
        • Altana Pharma/Nycomed
      • Steyr, Austria, 4400
        • Altana Pharma/Nycomed
      • Wiener Neustadt, Austria, 2700
        • Altana Pharma/Nycomed
  • Canada
      • Brandon, Canada, R7A 5E7
        • Altana Pharma/Nycomed
      • Hamilton, Canada, L8N 3Z5
        • Altana Pharma/Nycomed
      • London, Canada, N6C 4Y7
        • Altana Pharma/Nycomed
      • London, Canada, N5W 6A2
        • Altana Pharma/Nycomed
      • Mississauga, Canada, L5B 1N1
        • Altana Pharma/Nycomed
      • Montreal, Canada, H2L 4M1
        • Altana Pharma/Nycomed
      • Montreal, Canada, H4J1C5
        • Altana Pharma/Nycomed
      • Montreal, Quebec, Canada, H1V 1X5
        • Altana Pharma/Nycomed
      • Ottawa, Canada, K1Y 4G2
        • Altana Pharma/Nycomed
      • Quebec City, Canada, G8T 7A1
        • Altana Pharma/Nycomed
      • Sainte-Foy, Quebec, Canada, G1V4G5
        • Altana Pharma/Nycomed
      • Sarnia, Canada, N7T 4X3
        • Altana Pharma/Nycomed
      • Ste-Foy PQ, Canada, G1V 4M6
        • Altana Pharma/Nycomed
      • Toronto, Canada, M4P1P2
        • Altana Pharma/Nycomed
      • Woodstock, Canada, N4S 4G3
        • Altana Pharma/Nycomed
  • Germany
      • Geesthacht, Germany, 21502
        • Altana Pharma/Nycomed
      • Hannover, Germany, 30167
        • Altana Pharma/Nycomed
      • Heidelberg, Germany, 69117
        • Altana Pharma/Nycomed
      • Koblenz, Germany, 56068
        • Altana Pharma/Nycomed
      • Mainz, Germany, 55131
        • Altana Pharma/Nycomed
      • Marburg, Germany, 35037
        • Altana Pharma/Nycomed
      • Sinsheim, Germany, 74889
        • Altana Pharma/Nycomed
      • Witten, Germany, 58452
        • Altana Pharma/Nycomed
  • Poland
      • Bielsko-Biala, Poland, 43316
        • Altana Pharma/Nycomed
      • Gdansk, Poland, 80-847
        • Altana Pharma/Nycomed
      • Lodz, Poland, 90-141
        • Altana Pharma/Nycomed
      • Lubin, Poland, 59300
        • Altana Pharma/Nycomed
      • Lublin, Poland, 20-718
        • Altana Pharma/Nycomed
      • Lublin, Poland, 20601
        • Altana Pharma/Nycomed
      • Walbrzych, Poland, 58300
        • Altana Pharma/Nycomed
      • Zgierz, Poland, 95100
        • Altana Pharma/Nycomed
  • South Africa
      • Arcadia, Pretoria, South Africa, 132
        • Altana Pharma/Nycomed
      • Bellville, Cape Town, South Africa, 7530
        • Altana Pharma/Nycomed
      • Cape Town, South Africa, 7764
        • Altana Pharma/Nycomed
      • Cape Town, Tygerberg, South Africa, 7505
        • Altana Pharma/Nycomed
      • Durbanville / Cape Town, South Africa, 7550
        • Altana Pharma/Nycomed
      • Gatesville, Cape Town, South Africa, 7764
        • Altana Pharma/Nycomed
      • Lyttleton, South Africa, 140
        • Altana Pharma/Nycomed
      • Mowbray, Cape Town, South Africa, 7925
        • Altana Pharma/Nycomed
      • Observatory Cape, South Africa, 7925
        • Altana Pharma/Nycomed
      • Pretoria, South Africa, 181
        • Altana Pharma/Nycomed
      • Pretoria, South Africa, 2
        • Altana Pharma/Nycomed
      • Westville, South Africa, 3630
        • Altana Pharma/Nycomed
      • Wynberg, South Africa, 7945
        • 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

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Outpatients
  • Written informed consent
  • History of bronchial asthma for at least 6 months
  • Good health with the exception of asthma
  • Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
  • FEV1 80 - 105% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Current smoking with more than 10 pack-years
  • Previous smoking with more than 10 pack-years
  • Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception

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
time to the first asthma exacerbation.

Secondary Outcome Measures

Outcome Measure
adverse events
physical examination
FVC
vital signs
use of rescue medication
asthma symptom score
AQLQ(S) and EQ-5D
percentage of days on which patients perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
standard laboratory work-up
number of patients with local oropharyngeal adverse events.

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

November 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

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)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY9010/M1-142

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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