Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)

December 7, 2016 updated by: AstraZeneca

BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients

The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. 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 (Anticipated)

1000

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

  • Brazil
      • Campinas - SP, Brazil, 13081970
        • Altana Pharma/Nycomed
      • Curitiba-PR, Brazil, 80060900
        • Altana Pharma/Nycomed
      • Paraná, Brazil, 80060900
        • Altana Pharma/Nycomed
      • Pinheiros Sao Paulo - SP, Brazil, 1246-000
        • Altana Pharma/Nycomed
      • Porto Alegre-RS, Brazil, 90035003
        • Altana Pharma/Nycomed
      • Porto Alegre-RS, Brazil, 90610000
        • Altana Pharma/Nycomed
      • Recife-PE, Brazil, 50670901
        • Altana Pharma/Nycomed
      • Rio Grande, Brazil, 90610000
        • Altana Pharma/Nycomed
      • Rio de Janeiro-RJ, Brazil, 21941590
        • Altana Pharma/Nycomed
      • Salvador - Bahia, Brazil, 41920000
        • Altana Pharma/Nycomed
      • Santo André-SP, Brazil, 9060650
        • Altana Pharma/Nycomed
      • Sao Paulo, Brazil, 1277900
        • Altana Pharma/Nycomed
      • Sao Paulo, Brazil, 5403900
        • Altana Pharma/Nycomed
      • Sao Paulo, Brazil, 5651
        • Altana Pharma/Nycomed
      • Sao Paulo, Brazil
        • Altana Pharma/Nycomed
      • Sao Paulo - SP, Brazil, 5437000
        • Altana Pharma/Nycomed
      • Sao Paulo-SP, Brazil, 4025002
        • Altana Pharma/Nycomed
      • São Paulo-SP, Brazil, 1221020
        • Altana Pharma/Nycomed
  • Germany
      • Berlin, Germany, 13353
        • Altana Pharma/Nycomed
      • Dresden, Germany, 1307
        • Altana Pharma/Nycomed
      • Düsseldorf, Germany, 40225
        • Altana Pharma/Nycomed
      • Frankfurt, Germany, 60590
        • Altana Pharma/Nycomed
      • Heidelberg, Germany, 69120
        • Altana Pharma/Nycomed
      • Köln, Germany, 50924
        • Altana Pharma/Nycomed
      • Mannheim, Germany, 68167
        • Altana Pharma/Nycomed
      • München, Germany, 80939
        • Altana Pharma/Nycomed
      • Rosenheim, Germany, 83026
        • Altana Pharma/Nycomed
      • Wesel, Germany, 46483
        • Altana Pharma/Nycomed
      • Wiefelstede, Germany, 26215
        • Altana Pharma/Nycomed
  • Hungary
      • Baja, Hungary, 6500
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1083
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1089
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1121
        • Altana Pharma/Nycomed
      • Debrecen, Hungary, 4012
        • Altana Pharma/Nycomed
      • Jaszbereny, Hungary, 5100
        • Altana Pharma/Nycomed
      • Kaposvár, Hungary, 7400
        • Altana Pharma/Nycomed
      • Kiskunhalas, Hungary, 6400
        • Altana Pharma/Nycomed
      • Miskolc, Hungary, 3501
        • Altana Pharma/Nycomed
      • Mosdós, Hungary, 7257
        • Altana Pharma/Nycomed
      • Mosonmagyaróvár, Hungary, 9200
        • Altana Pharma/Nycomed
      • Nyíregyháza, Hungary, 4400
        • Altana Pharma/Nycomed
      • Pecs, Hungary, 7624
        • Altana Pharma/Nycomed
      • Szeged, Hungary, 6720
        • Altana Pharma/Nycomed
      • Szekszárd, Hungary, 7100
        • Altana Pharma/Nycomed
      • Törökbalint, Hungary, 2045
        • Altana Pharma/Nycomed
  • India
      • Chandanwadi, Thane, India, 400061
        • 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
      • Gulbarga, India, 585104
        • Altana Pharma/Nycomed
      • Mumbai, India, 400 004
        • Altana Pharma/Nycomed
      • Mumbai, India, 400008
        • Altana Pharma/Nycomed
      • Mumbai, Dadar (E), India, 400 014
        • Altana Pharma/Nycomed
      • Nagpur, India, 12
        • Altana Pharma/Nycomed
      • Noida, India, 201301
        • Altana Pharma/Nycomed
      • Pune, India, 411 001
        • Altana Pharma/Nycomed
      • Pune, India, 411 033
        • Altana Pharma/Nycomed
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Altana Pharma/Nycomed
      • Enschede, Netherlands, 7511 JX
        • Altana Pharma/Nycomed
      • Hoofddorp, Netherlands, 2134 TM
        • Altana Pharma/Nycomed
      • Leeuwarden, Netherlands, 8901 BR
        • Altana Pharma/Nycomed
      • Nijmegen, Netherlands, 6532 SZ
        • Altana Pharma/Nycomed
      • Zwolle, Netherlands, 8025 AB
        • Altana Pharma/Nycomed
  • Poland
      • Karpacz, Poland, 58-540
        • Altana Pharma/Nycomed
      • Lublin, Poland, 20-093
        • Altana Pharma/Nycomed
      • Opole, Poland, 45401
        • Altana Pharma/Nycomed
      • Poznan, Poland, 60-214
        • Altana Pharma/Nycomed
      • Poznan, Poland, 60-693
        • Altana Pharma/Nycomed
      • Zawadzkie, Poland, 46-059
        • Altana Pharma/Nycomed
  • South Africa
      • Bellville - Cape Town -, South Africa, 7530
        • Altana Pharma/Nycomed
      • Cape Town, South Africa, 7937
        • Altana Pharma/Nycomed
      • Durban, South Africa, 3630
        • Altana Pharma/Nycomed
      • Morningside, Sandton, South Africa, 2196
        • Altana Pharma/Nycomed
      • Mowbray, Cape Town, South Africa, 7925
        • Altana Pharma/Nycomed
      • New Redruth, Alberton, South Africa, 1450
        • Altana Pharma/Nycomed
      • Overport, Durban, South Africa, 4091
        • Altana Pharma/Nycomed
      • Panorama / RSA-Cape Town, South Africa, 7500
        • Altana Pharma/Nycomed
      • Pietermaritzburg, South Africa, 3201
        • Altana Pharma/Nycomed
      • Westville, South Africa, 3630
        • Altana Pharma/Nycomed
      • Wynberg, South Africa, 7945
        • Altana Pharma/Nycomed
  • Spain
      • Barcelona, Spain, 8222
        • Altana Pharma/Nycomed
      • Barcelona, Spain, 8003
        • Altana Pharma/Nycomed
      • Barcelona, Spain, 8023
        • Altana Pharma/Nycomed
      • El Palmar (Murcia), Spain, 30120
        • Altana Pharma/Nycomed
      • Elche - Alicante, Spain, 3203
        • Altana Pharma/Nycomed
      • Leganes (Madrid), Spain, 28911
        • Altana Pharma/Nycomed
      • Madrid, Spain, 28006
        • Altana Pharma/Nycomed
      • Madrid, Spain, 28009
        • Altana Pharma/Nycomed
      • Madrid, Spain, 28041
        • Altana Pharma/Nycomed
      • Sabadell, Spain, 8208
        • Altana Pharma/Nycomed
      • Sevilla, Spain, 41071
        • Altana Pharma/Nycomed
      • Valencia, Spain, 46009
        • Altana Pharma/Nycomed
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Altana Pharma/Nycomed
      • Trimbach, Switzerland, 4632
        • Altana Pharma/Nycomed
      • Zürich, Switzerland, 8032
        • 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

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Written informed consent by the parents or legal guardians of the patient
  • Outpatients
  • Good health with the exception of asthma
  • Documented diagnosis of asthma for more than 6 months
  • Use of rescue medication only or pretreatment with a controller drug

Main Exclusion Criteria:

  • Concomitant severe diseases
  • Diseases contraindicated for the use of inhaled steroids
  • Other relevant lung diseases causing impairment in pulmonary function
  • Recurrent, episodic wheezing only
  • History of life-threatening asthma
  • History of any mechanical ventilation
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
  • Premature birth (< 32 weeks gestation)

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Placebo
Drug: Placebo
Placebo
Active Comparator: 1
Ciclesonide 40 µg
Drug: Ciclesonide
Efficacy and Safety of Ciclesonide
Active Comparator: 2
Ciclesonide 80 µg
Drug: Ciclesonide
Efficacy and Safety of Ciclesonide
Active Comparator: 3
Ciclesonide 160 µg
Drug: Ciclesonide
Efficacy and Safety of Ciclesonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to first moderate or severe asthma exacerbation.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 24 weeks
24 weeks
rate of patients with moderate or severe asthma exacerbation
Time Frame: 24 weeks
24 weeks
rate of patients with moderate asthma exacerbation
Time Frame: 24 weeks
24 weeks
rate of patients with severe asthma exacerbation
Time Frame: 24 weeks
24 weeks
time to first moderate asthma exacerbation
Time Frame: 24 weeks
24 weeks
time to first severe asthma exacerbation
Time Frame: 24 weeks
24 weeks
asthma symptom score from diary
Time Frame: 24 weeks
24 weeks
use of rescue medication
Time Frame: 24 weeks
24 weeks
patient perceived asthma control
Time Frame: 24 weeks
24 weeks
quality of life data (PACQLQ)
Time Frame: 24 weeks
24 weeks
morning and evening PEF from diary
Time Frame: 24 weeks
24 weeks
pulmonary function variables measured at the investigational sites
Time Frame: 24 weeks
24 weeks
physical examination
Time Frame: 24 weeks
24 weeks
vital signs
Time Frame: 24 weeks
24 weeks
laboratory work-up
Time Frame: 24 weeks
24 weeks
serum cortisol
Time Frame: 24 weeks
24 weeks
urine cortisol variables
Time Frame: 24 weeks
24 weeks
body growth determined by stadiometry.
Time Frame: 24 weeks
24 weeks

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

November 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

May 1, 2007

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/M1-207

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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