Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)

November 29, 2016 updated by: AstraZeneca

Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma

The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Drug: Ciclesonide

Study Type

Interventional

Enrollment

450

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

Canada
- - La Malbaie, Quebec, Canada, G5A 1W7
    - Altana Pharma/Nycomed
  - London, Canada, N6A 5R9
    - Altana Pharma/Nycomed
  - London,ON, Canada, N6A1V2
    - Altana Pharma/Nycomed
  - Mississauga, Canada, L5B 1N1
    - Altana Pharma/Nycomed
  - Montreal, Quebec, Canada, H1V 1X5
    - Altana Pharma/Nycomed
  - Quebec City, Canada, G8T 7A1
    - Altana Pharma/Nycomed
  - Richmond Hill, Canada, L4S 1P3
    - Altana Pharma/Nycomed
  - Sainte-Foy, Quebec, Canada, G1V4G5
    - Altana Pharma/Nycomed
  - Saskatoon,SK, Canada, S7H 0W2
    - Altana Pharma/Nycomed
  - Scarborough,ON, Canada, M1B 4Z8
    - Altana Pharma/Nycomed
  - Toronto, Canada, M4P1P2
    - Altana Pharma/Nycomed
  - Vancouver, BC, Canada, V5Z 4E1
    - Altana Pharma/Nycomed
  - Winnipeg, Canada, R2M 5L9
    - Altana Pharma/Nycomed
  - Winnipeg MB, Canada, R3C 0N2
    - Altana Pharma/Nycomed
  - Woodstock, Canada, N4S 4G3
    - Altana Pharma/Nycomed
France
- - Aix En Provence, France, 13090
    - Altana Pharma/Nycomed
  - Chauny CEDEX, France, 2303
    - Altana Pharma/Nycomed
  - Ferolles-Attily, France, 77150
    - Altana Pharma/Nycomed
  - Grasse, France, 6130
    - Altana Pharma/Nycomed
  - La Rochelle, France, 17000
    - Altana Pharma/Nycomed
  - La Teste de Buch, France, 33260
    - Altana Pharma/Nycomed
  - Libourne, France, 33500
    - Altana Pharma/Nycomed
  - Lille, France, 59000
    - Altana Pharma/Nycomed
  - Martigues Cedex, France, 13695
    - Altana Pharma/Nycomed
  - Montbrison, France, 42600
    - Altana Pharma/Nycomed
  - Montpellier Cedex, France, 34070
    - Altana Pharma/Nycomed
  - Nice, France, 6000
    - Altana Pharma/Nycomed
  - Nimes, France, 30900
    - Altana Pharma/Nycomed
  - Saint Laurent Du Var, France, 6700
    - Altana Pharma/Nycomed
  - Saint-Quentin, France, 2100
    - Altana Pharma/Nycomed
Germany
- - Berlin, Germany, 10717
    - Altana Pharma/Nycomed
  - Berlin, Germany, 13597
    - Altana Pharma/Nycomed
  - Oschersleben, Germany, 39387
    - Altana Pharma/Nycomed
  - Rüdersdorf, Germany, 15562
    - Altana Pharma/Nycomed
  - Schwetzingen, Germany, 68723
    - Altana Pharma/Nycomed
  - Weinheim, Germany, 69469
    - Altana Pharma/Nycomed
Hungary
- - Balassagyarmat, Hungary, 2660
    - Altana Pharma/Nycomed
  - Budapest, Hungary, 1121
    - Altana Pharma/Nycomed
  - Budapest, Hungary, 1134
    - Altana Pharma/Nycomed
  - Budapet, Hungary, 1529
    - Altana Pharma/Nycomed
  - Gyula, Hungary, 5703
    - Altana Pharma/Nycomed
  - Komárom, Hungary, 2900
    - Altana Pharma/Nycomed
  - Miskolc, Hungary, 3501
    - Altana Pharma/Nycomed
  - Mosdós, Hungary, 7257
    - Altana Pharma/Nycomed
  - Nyiregyháza, Hungary, 4412
    - Altana Pharma/Nycomed
  - Pécs, Hungary, 7621
    - Altana Pharma/Nycomed
  - Szeged, Hungary, 6722
    - Altana Pharma/Nycomed
  - Székesfehérvár, Hungary, 8000
    - Altana Pharma/Nycomed
  - Érd, Hungary, 2030
    - Altana Pharma/Nycomed
India
- - Bangalore, India, 560 034
    - Altana Pharma/Nycomed
  - Chennai, India, 600 034
    - Altana Pharma/Nycomed
  - Coimbatore, India, 641004
    - Altana Pharma/Nycomed
  - Coimbatore, India, 641 014
    - Altana Pharma/Nycomed
  - Coimbatore, Tamilnadu, India, 641 044
    - Altana Pharma/Nycomed
  - Goa, India, 403 002
    - Altana Pharma/Nycomed
  - Gulbarga, India, 585105
    - Altana Pharma/Nycomed
  - Mumbai, India, 400008
    - Altana Pharma/Nycomed
  - Mumbai, Dadar (E), India, 400 014
    - Altana Pharma/Nycomed
  - Pune, India
    - Altana Pharma/Nycomed
Italy
- - Firenze, Italy, 50134
    - Altana Pharma/Nycomed
  - Milano, Italy, 20122
    - Altana Pharma/Nycomed
  - Milano, Italy, 20142
    - Altana Pharma/Nycomed
  - Milano, Italy, 20153
    - Altana Pharma/Nycomed
  - Napoli, Italy, 80131
    - Altana Pharma/Nycomed
  - Pordenone, Italy, 33170
    - Altana Pharma/Nycomed
  - Verona, Italy, 30012
    - 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

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

Written informed consent
History of persistent bronchial asthma for at least 6 months
Good health with the exception of asthma

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Smoking history with ≥10 cigarette pack years
Pregnancy
Intention to become pregnant
Breast feeding
Lack of safe contraception
Previous enrolment into the current study

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
FEV1.

Secondary Outcome Measures

Outcome Measure
adverse events
physical examination
FVC
vital signs
use of rescue medication
asthma symptom score
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
standard laboratory work-up
morning and evening PEF from diaries
number of patients with an asthma exacerbation
time to the first asthma exacerbation
percentage of days on which patient perceived asthma control
8 am serum cortisol.

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

BY9010-MI-145-RDS-2007-05-21.pdf

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, 2005

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)

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/M1-145

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.