Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)

November 29, 2016 updated by: AstraZeneca

Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control

The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

630

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

  • Australia
      • Adelaide South Australia, Australia, 5000
        • Altana Pharma/Nycomed
      • Auchenflower, Australia, QLD 4066
        • Altana Pharma/Nycomed
      • Bracken Ridge, Australia, QLD 4017
        • Altana Pharma/Nycomed
      • Burwood, Australia, NSW 2134
        • Altana Pharma/Nycomed
      • Camperdown, Australia, NSW 2050
        • Altana Pharma/Nycomed
      • Carina Heights, Australia, QLD 4152
        • Altana Pharma/Nycomed
      • Clayton, Australia, VIC 3168
        • Altana Pharma/Nycomed
      • Concord, Australia, 2139
        • Altana Pharma/Nycomed
      • Geelong, Australia, VIC 3220
        • Altana Pharma/Nycomed
      • Inala, Australia, QLD 4077
        • Altana Pharma/Nycomed
      • Kippa-ring, Australia, QLD 4021
        • Altana Pharma/Nycomed
      • Nedlands, Australia, WA 6009
        • Altana Pharma/Nycomed
      • Rosebud, Australia, VIC 3939
        • Altana Pharma/Nycomed
      • South Brisbane, Australia, QLD 4101
        • Altana Pharma/Nycomed
      • Toorak Gardens, Australia, SA 5056
        • Altana Pharma/Nycomed
      • Wayville, Australia, SA 5034
        • Altana Pharma/Nycomed
  • Canada
      • Beaconsfield, QC, Canada, H9W2X3
        • Altana Pharma/Nycomed
      • Coquitlam, Canada, V3K 3P4
        • Altana Pharma/Nycomed
      • Coquitlam, BC, Canada, V3K 3V9
        • Altana Pharma/Nycomed
      • Corner Brook, Canada, NFLD
        • Altana Pharma/Nycomed
      • Cowansville, Canada, J2K2X9
        • Altana Pharma/Nycomed
      • Kingston, Ontario, Canada, K7L 2V6
        • Altana Pharma/Nycomed
      • Langley BC, Canada, V3A 4H9
        • Altana Pharma/Nycomed
      • Laval, Canada, H7V3Y7
        • Altana Pharma/Nycomed
      • Les Saules, QC, Canada, G1P 1J6
        • Altana Pharma/Nycomed
      • Longueuil, PQ, Canada, J4N 1E1
        • Altana Pharma/Nycomed
      • Montreal, Canada, H4J1C5
        • Altana Pharma/Nycomed
      • Montreal, PQ, Canada, H3H 1V4
        • Altana Pharma/Nycomed
      • North Bay, Canada, P1B2H3
        • Altana Pharma/Nycomed
      • North York, Canada, M3H 3S3
        • Altana Pharma/Nycomed
      • Ottawa, Canada, K1Y 4G2
        • Altana Pharma/Nycomed
      • Penticton, BC, Canada, V2A 5C8
        • Altana Pharma/Nycomed
      • Quebec City, Canada, G8T 7A1
        • Altana Pharma/Nycomed
      • Saint John, Canada, E2K2T8
        • Altana Pharma/Nycomed
      • Saint John's, Canada, A1A 3R5
        • Altana Pharma/Nycomed
      • Sainte-Foy, Quebec, Canada, G1V4G5
        • Altana Pharma/Nycomed
      • Saskatoon, SK, Canada, S7K 3H3
        • Altana Pharma/Nycomed
      • St. John's, Canada, A1E 2C2
        • Altana Pharma/Nycomed
      • Ste-Foy PQ, Canada, G1V 4M6
        • Altana Pharma/Nycomed
      • Toronto, Canada, M4P1P2
        • Altana Pharma/Nycomed
      • Toronto, Canada, M4N3N5
        • Altana Pharma/Nycomed
      • Toronto, Canada, M9W 4L6
        • Altana Pharma/Nycomed
      • Toronto ON, Canada, M5S 2A5
        • Altana Pharma/Nycomed
  • Czech Republic
      • Beroun, Czech Republic, 266 01
        • Altana Pharma/Nycomed
      • Ceska Lipa, Czech Republic, 470 01
        • Altana Pharma/Nycomed
      • Cvikov, Czech Republic, 471 54
        • Altana Pharma/Nycomed
      • Havlickuv, Czech Republic, 580 01
        • Altana Pharma/Nycomed
      • Jihlava, Czech Republic, 58601
        • Altana Pharma/Nycomed
      • Jindrichuv Hradec, Czech Republic, 377 01
        • Altana Pharma/Nycomed
      • Karlovy Vary, Czech Republic, 360 00
        • Altana Pharma/Nycomed
      • Kladno, Czech Republic, 272 01
        • Altana Pharma/Nycomed
      • Kutná Hora, Czech Republic, 28401
        • Altana Pharma/Nycomed
      • Ostrava-Marián.Hory, Czech Republic, 70030
        • Altana Pharma/Nycomed
      • Praha 10, Czech Republic, 100 00
        • Altana Pharma/Nycomed
      • Praha 2, Czech Republic, 128 00
        • Altana Pharma/Nycomed
      • Praha 4, Czech Republic, 14046
        • Altana Pharma/Nycomed
      • Praha 8, Czech Republic, 181 00
        • Altana Pharma/Nycomed
      • Praha 9, Czech Republic, 190 61
        • Altana Pharma/Nycomed
      • Pribram VI, Czech Republic, 261 05
        • Altana Pharma/Nycomed
      • Príbram VIII, Czech Republic, 261 01
        • Altana Pharma/Nycomed
      • Rokycany, Czech Republic, 337 01
        • Altana Pharma/Nycomed
      • Strakonice, Czech Republic, 38601
        • Altana Pharma/Nycomed
      • Trutnov, Czech Republic, 54101
        • Altana Pharma/Nycomed
      • Usti nad Labem, Czech Republic, 401 13
        • Altana Pharma/Nycomed
  • Hungary
      • Budapest, Hungary, 1529
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1134
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1046
        • Altana Pharma/Nycomed
      • Budapest XI, Hungary, 1117
        • Altana Pharma/Nycomed
      • Budapet, Hungary, 1529
        • Altana Pharma/Nycomed
      • Kecskemet, Hungary, 6000
        • Altana Pharma/Nycomed
      • Nyíregyháza, Hungary, 4400
        • Altana Pharma/Nycomed
      • Szarvas, Hungary, 5540
        • Altana Pharma/Nycomed
      • Tatabanya, Hungary, 2800
        • Altana Pharma/Nycomed
  • Poland
      • Bydgoszcz, Poland, 85-681
        • Altana Pharma/Nycomed
      • Bydgoszcz, Poland, 85-091
        • Altana Pharma/Nycomed
      • Lodz, Poland, 91-520
        • Altana Pharma/Nycomed
      • Lódz', Poland, 90-153
        • Altana Pharma/Nycomed
      • Rzeszow, Poland, 35-068
        • Altana Pharma/Nycomed
      • Rzeszow, Poland, 35-302
        • Altana Pharma/Nycomed
      • Warszawa, Poland, 01-138
        • Altana Pharma/Nycomed
      • Wroclaw, Poland, 50-417
        • Altana Pharma/Nycomed
      • Wroclaw, Poland, 53-674
        • Altana Pharma/Nycomed
  • South Africa
      • Arcadia, Pretoria, South Africa, 132
        • Altana Pharma/Nycomed
      • Bellville, Cape Town, South Africa, 7530
        • Altana Pharma/Nycomed
      • Berea, Durban, South Africa, 4000
        • Altana Pharma/Nycomed
      • Bloemfontein, South Africa, 9300
        • Altana Pharma/Nycomed
      • Bloemfontein, South Africa, 9301
        • Altana Pharma/Nycomed
      • Cape Town, South Africa, 7764
        • Altana Pharma/Nycomed
      • Centurion, Pretoria, South Africa, 157
        • Altana Pharma/Nycomed
      • Daveyton, South Africa, 1520
        • Altana Pharma/Nycomed
      • Durban, Amanzimtoti, South Africa, 4126
        • Altana Pharma/Nycomed
      • George, South Africa, 6539
        • Altana Pharma/Nycomed
      • Midrand, South Africa, 1685
        • Altana Pharma/Nycomed
      • Mowbray, Cape Town, South Africa, 7925
        • Altana Pharma/Nycomed
      • Paarl, South Africa, 7646
        • Altana Pharma/Nycomed
      • Panorama / RSA-Cape Town, South Africa, 7500
        • Altana Pharma/Nycomed
      • Pretoria, South Africa, 186
        • Altana Pharma/Nycomed
  • Spain
      • Alcorcón (Madrid), Spain, 28922
        • Altana Pharma/Nycomed
      • Alicante, Spain, 3001
        • Altana Pharma/Nycomed
      • Alicante, Spain, 3540
        • Altana Pharma/Nycomed
      • Barcelona, Spain, 8222
        • Altana Pharma/Nycomed
      • Campdevanol (Girona), Spain, 17530
        • Altana Pharma/Nycomed
      • Elda (Alicante), Spain, 3600
        • Altana Pharma/Nycomed
      • Guadalajara, Spain, 19002
        • Altana Pharma/Nycomed
      • Leganes (Madrid), Spain, 28914
        • Altana Pharma/Nycomed
      • Palma de Mallorca, Spain, 7014
        • Altana Pharma/Nycomed
      • Peralada (Girona), Spain, 17491
        • Altana Pharma/Nycomed
      • Petrer (Alicante), Spain, 3610
        • Altana Pharma/Nycomed
      • San Vicente del Raspeig (Alicante), Spain, 3187
        • Altana Pharma/Nycomed
      • Santiago de Compostela, Spain, 15706
        • Altana Pharma/Nycomed
      • Valencia, Spain, 46017
        • 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:

  • Clinical diagnosis of mild persistent asthma
  • Pre-treatment with SABAs only
  • FEV1 ≥80% predicted
  • Good health with the exception of asthma

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
  • Current smokers ≥10 pack-years and ex-smokers with ≥10 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
time until the first severe asthma exacerbation occurs
number of poorly controlled asthma days.

Secondary Outcome Measures

Outcome Measure
vital signs
asthma symptom score
laboratory work-up
adverse events.
percentage of days with asthma control
percentage of days with asthma symptoms
percentage of nocturnal awakenings due to asthma
number of inhalations of rescue medication
proportion of patients with severe asthma exacerbations
differences in morning PEF from diary
differences in FEV1 and FVC from spirometry
blood eosinophils
AQLQ(S)
health economic data

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.

General Publications

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

September 1, 2003

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 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/M1-132

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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