Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206) - Full Text View

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163462

Purpose

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; 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 (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Ciclesonide (80 Mcg or 160 Mcg Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

FEV1 absolute values
PD20FEV1 from methacholine challenge.

Secondary Outcome Measures:

FEV1 as % of predicted
PEF from spirometry
morning and evening PEF from diary
asthma symptom score from diary
salbutamol MDI use from diary
diurnal PEF fluctuation from diary
dropout rate due to asthma exacerbations and time to the first asthma exacerbation
percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
interview administered PAQLQ(S), self-administered PACQLQ
physical examination and vital signs
laboratory investigation
AEs
HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.

Estimated Enrollment:	750
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

History of persistent bronchial asthma for at least 6 months
FEV1 50-90% of predicted

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 lung function
Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
History of life-threatening asthma
Premature birth
Current smoking
Smoking history with either equal or more than 10 pack-years
Pregnancy
Intention to become pregnant during the course of the study
Breast feeding
Lack of safe contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163462

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Locations

Brazil
Altana Pharma/Nycomed
São Paulo-SP, Brazil, 1221020
Altana Pharma/Nycomed
Campinas - SP, Brazil, 13081970
Altana Pharma/Nycomed
Rio de Janeiro-RJ, Brazil, 21941590
Altana Pharma/Nycomed
Sao Paulo - SP, Brazil, 5437000
Altana Pharma/Nycomed
Salvador - Bahia, Brazil, 41920000
Altana Pharma/Nycomed
São Paulo-SP, Brazil, 5403900
Altana Pharma/Nycomed
Sao Paulo-SP, Brazil, 4025002
Altana Pharma/Nycomed
Curitiba-PR, Brazil, 80060900
Altana Pharma/Nycomed
Florianópolis-SC, Brazil, 88040970
Altana Pharma/Nycomed
Porto Alegre-RS, Brazil, 90035003
Altana Pharma/Nycomed
Santo André-SP, Brazil, 9060650
Altana Pharma/Nycomed
Porto Alegre-RS, Brazil, 90610000
Germany
Altana Pharma/Nycomed
Geesthacht, Germany, 21502
Altana Pharma/Nycomed
Wiefelstede, Germany, 26215
Altana Pharma/Nycomed
Wesel, Germany, 46483
Altana Pharma/Nycomed
Mainz, Germany, 55101
Altana Pharma/Nycomed
Frankfurt, Germany, 60590
Altana Pharma/Nycomed
München, Germany, 80337
Altana Pharma/Nycomed
München, Germany, 80939
Altana Pharma/Nycomed
Gaißach bei Bad Tölz, Germany, 83674
Hungary
Altana Pharma/Nycomed
Budapest, Hungary, 1083
Altana Pharma/Nycomed
Mosdos, Hungary, 7257
Altana Pharma/Nycomed
Budapest, Hungary, 1121
Altana Pharma/Nycomed
Törökbalint, Hungary, 2045
Altana Pharma/Nycomed
Miskolc, Hungary, 3501
Altana Pharma/Nycomed
Debrecen, Hungary, 4012
Altana Pharma/Nycomed
Jaszbereny, Hungary, 5100
Altana Pharma/Nycomed
Budapest, Hungary, 1089
Altana Pharma/Nycomed
Pecs, Hungary, 7624
Poland
Altana Pharma/Nycomed
Warszawa, Poland, 01-211
Altana Pharma/Nycomed
Warszawa, Poland, 03-924
Altana Pharma/Nycomed
Lublin, Poland, 20-093
Altana Pharma/Nycomed
Inowroclaw, Poland, 88-100
Altana Pharma/Nycomed
Zawadzkie, Poland, 46-059
Altana Pharma/Nycomed
Poznan, Poland, 60-214
Altana Pharma/Nycomed
Rzeszow, Poland, 35-301
Altana Pharma/Nycomed
Lodz, Poland, 90-141
Portugal
Altana Pharma/Nycomed
Lisboa, Portugal, 1269-098
Altana Pharma/Nycomed
Lisboa, Portugal, 1649035
Altana Pharma/Nycomed
Lisboa, Portugal, 1990050
Altana Pharma/Nycomed
Oliveira de Azemeis, Portugal, 3720000
Altana Pharma/Nycomed
Setúbal, Portugal, 2910446
Altana Pharma/Nycomed
Amadora, Portugal, 2720276
Altana Pharma/Nycomed
Porto, Portugal, 4099-001
Altana Pharma/Nycomed
Porto, Portugal, 4200319
Altana Pharma/Nycomed
Vila Nova de Gaia, Portugal, 4400-123
Altana Pharma/Nycomed
Matosinhos, Portugal, 4450024
Altana Pharma/Nycomed
Faro, Portugal, 8000-386
Altana Pharma/Nycomed
Viana do Castelo, Portugal, 4901858
Altana Pharma/Nycomed
Guimaraes, Portugal, 4800055
South Africa
Altana Pharma/Nycomed
Wynberg, South Africa, 7945
Altana Pharma/Nycomed
Westville, South Africa, 3630
Altana Pharma/Nycomed
Panorama / RSA-Cape Town, South Africa, 7500
Altana Pharma/Nycomed
Bellville - Cape Town -, South Africa, 7530
Altana Pharma/Nycomed
Mowbray, Cape Town, South Africa, 7925
Altana Pharma/Nycomed
Cape Town, South Africa, 7937
Altana Pharma/Nycomed
Morningside, Sandton, South Africa, 2196

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Søren Pedersen, Prof.

Odense University Hospital, Kolding, Denmark

More Information

No publications provided

Study ID Numbers:	BY9010/M1-206
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163462 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Child
Fluticasone propionate
Pediatric

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Ciclesonide
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 22, 2009