Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

December 1, 2016 updated by: AstraZeneca

Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma

The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Drug: Ciclesonide

Study Type

Interventional

Enrollment

500

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

Belgium
- - Bruxelles, Belgium, 1040
    - Altana Pharma/Nycomed
  - Bruxelles, Belgium, 1000
    - Altana Pharma/Nycomed
  - Bruxelles, Belgium, 1190
    - Altana Pharma/Nycomed
  - Halen, Belgium, 3545
    - Altana Pharma/Nycomed
  - Jette, Belgium, 1090
    - Altana Pharma/Nycomed
  - Maison-Saint-Gérard, Belgium, 5640
    - Altana Pharma/Nycomed
  - Namur, Belgium, 5000
    - Altana Pharma/Nycomed
  - Oostende, Belgium, 8400
    - Altana Pharma/Nycomed
  - Turnhout, Belgium, 2300
    - Altana Pharma/Nycomed
  - Veurne, Belgium, 8630
    - Altana Pharma/Nycomed
France
- - Aix En Provence, France, 13090
    - Altana Pharma/Nycomed
  - Beziers, France, 34500
    - Altana Pharma/Nycomed
  - Chauny CEDEX, France, 2303
    - Altana Pharma/Nycomed
  - Grasse, France, 6130
    - Altana Pharma/Nycomed
  - La Rochelle, France, 17000
    - Altana Pharma/Nycomed
  - Marseille, France, 13008
    - Altana Pharma/Nycomed
  - Martigues Cedex, France, 13695
    - Altana Pharma/Nycomed
  - Metz, France, 57000
    - Altana Pharma/Nycomed
  - Montfermeil, France, 93370
    - Altana Pharma/Nycomed
  - Montpellier Cedex, France, 34070
    - Altana Pharma/Nycomed
  - Nice, France, 6000
    - Altana Pharma/Nycomed
  - Nimes, France, 30900
    - Altana Pharma/Nycomed
  - Paris, France, 75014
    - Altana Pharma/Nycomed
  - Perpignan CEDEX, France, 66046
    - Altana Pharma/Nycomed
  - Vieux Conde, France, 59690
    - Altana Pharma/Nycomed
Italy
- - Ancona, Italy, 60100
    - Altana Pharma/Nycomed
  - Brescia, Italy, 25123
    - Altana Pharma/Nycomed
  - Chieti, Italy, 66100
    - Altana Pharma/Nycomed
  - Firenze, Italy, 50134
    - Altana Pharma/Nycomed
  - Livorno, Italy, 57124
    - Altana Pharma/Nycomed
  - Milano, Italy, 20122
    - Altana Pharma/Nycomed
  - Milano, Italy, 20142
    - Altana Pharma/Nycomed
  - Milazzo (ME), Italy, 98057
    - Altana Pharma/Nycomed
  - Napoli, Italy, 80131
    - Altana Pharma/Nycomed
  - Pavia, Italy, 27100
    - Altana Pharma/Nycomed
  - Pirri-Cagliari, Italy, 9134
    - Altana Pharma/Nycomed
  - Pordenone, Italy, 33170
    - Altana Pharma/Nycomed
  - Roma, Italy, 100
    - Altana Pharma/Nycomed
  - Verona, Italy, 30012
    - Altana Pharma/Nycomed
Netherlands
- - Almere, Netherlands, 1315 RA
    - Altana Pharma/Nycomed
  - Haarlem, Netherlands, 2012 CE
    - Altana Pharma/Nycomed
  - Harderwijk, Netherlands, 3844 DG
    - Altana Pharma/Nycomed
  - Heerlen, Netherlands, 6419 PC
    - Altana Pharma/Nycomed
  - Helmond, Netherlands, 5707 HA
    - Altana Pharma/Nycomed
  - Schiedam, Netherlands, 3116 BA
    - Altana Pharma/Nycomed
  - Utrecht, Netherlands, 3584 CX
    - Altana Pharma/Nycomed
  - Veldhoven, Netherlands, 5504 DB
    - Altana Pharma/Nycomed
Spain
- - Almeria, Spain, 4009
    - Altana Pharma/Nycomed
  - Barcelona, Spain, 8222
    - Altana Pharma/Nycomed
  - Córdoba, Spain, 14004
    - Altana Pharma/Nycomed
  - Elche, Spain, 3203
    - Altana Pharma/Nycomed
  - Guadalajara, Spain, 19002
    - Altana Pharma/Nycomed
  - Madrid, Spain, 28006
    - Altana Pharma/Nycomed
  - Madrid, Spain, 28040
    - Altana Pharma/Nycomed
  - Madrid, Spain, 28001
    - Altana Pharma/Nycomed
  - Madrid, Spain, 28047
    - Altana Pharma/Nycomed
  - Requena, Spain, 46340
    - Altana Pharma/Nycomed
  - San Sebastián, Spain, 20014
    - Altana Pharma/Nycomed
  - Valencia, Spain, 46014
    - Altana Pharma/Nycomed
  - Valencia, Spain, 46017
    - Altana Pharma/Nycomed
Switzerland
- - Basel, Switzerland, 4031
    - Altana Pharma/Nycomed
  - Bellinzona, Switzerland, 6500
    - Altana Pharma/Nycomed
  - Bern, Switzerland, 3012
    - Altana Pharma/Nycomed
  - Bruderholz, Switzerland, 4101
    - Altana Pharma/Nycomed
  - La Chauxe-de-Fonds, Switzerland, 2300
    - Altana Pharma/Nycomed
  - Lugano, Switzerland, 6900
    - Altana Pharma/Nycomed
  - Münchenstein, Switzerland, 4142
    - Altana Pharma/Nycomed
  - Münsingen, Switzerland, 3110
    - Altana Pharma/Nycomed
  - Münsterlingen, Switzerland, 8596
    - Altana Pharma/Nycomed
  - Zürich, Switzerland, 8050
    - Altana Pharma/Nycomed
  - Zürich, Switzerland, 8048
    - Altana Pharma/Nycomed
  - Zürich, Switzerland, 8063
    - Altana Pharma/Nycomed
United Kingdom
- - Belfast, United Kingdom, BT7 1DA
    - Altana Pharma/Nycomed
  - Belfast, Irland, United Kingdom, BT15 3LL
    - Altana Pharma/Nycomed
  - Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
    - Altana Pharma/Nycomed
  - Chesterfield Derbyshire, United Kingdom, S40 4TF
    - Altana Pharma/Nycomed
  - Chippenham, Wiltshire, United Kingdom, SN15 2SB
    - Altana Pharma/Nycomed
  - Co. Antrim, United Kingdom, BT38 8TP
    - Altana Pharma/Nycomed
  - Downpatrick, Northern Ireland, United Kingdom, BT30 6HY
    - Altana Pharma/Nycomed
  - Dronfield, United Kingdom, S18 1RU
    - Altana Pharma/Nycomed
  - Glengormley, United Kingdom, BT36 4PP
    - Altana Pharma/Nycomed
  - Glengormley Newtownabbey, United Kingdom, BT36 5EQ
    - Altana Pharma/Nycomed
  - Hastings, United Kingdom, TN34 3EY
    - Altana Pharma/Nycomed
  - Maidenhead, Berks, United Kingdom, SI6 2LH
    - Altana Pharma/Nycomed
  - Nottingham, United Kingdom, NG3 7DQ
    - Altana Pharma/Nycomed
  - Nottingham, United Kingdom, NG5 1PB
    - Altana Pharma/Nycomed
  - Solihull, United Kingdom, B91 2JL
    - Altana Pharma/Nycomed
  - Warminster Wiltshire, United Kingdom, BA12 9AA
    - Altana Pharma/Nycomed
  - Watford, United Kingdom, WD25 0EA
    - 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

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

Written informed consent
History of bronchial asthma for at least 6 months
Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
FEV1 ≥ 80% of predicted

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
COPD
Smoking with ≥10 pack-years
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
number of patients with candidiasis of the oropharynx or hoarseness.

Secondary Outcome Measures

Outcome Measure
adverse events
use of rescue medication
asthma symptom score
standard laboratory work-up
morning and evening PEF from diaries
number of patients with an asthma exacerbation
diurnal PEF fluctuation
inhaled Corticosteroids Questionnaire (ICQ)
proportion of cases of candidiasis of the oropharynx or
hoarseness at each visit Secondary variables
FEV1, FVC, PEF from spirometry
onset of treatment effect
percent days on which patient perceived asthma control
percent of nocturnal awakening-free days
percent of rescue medication free days
percent symptom free days
time to first asthma exacerbation
AQLQ
number of patients with candidiasis of the oropharynx or hoarseness by severity
physical examination, ECG
vital sings
morning serum cortisol
skin bruising.

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-IT-101-RDS-2006-09-21.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

November 1, 2004

Study Completion (Actual)

November 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)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BY9010/IT-101

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.