Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142) - Full Text View

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163423

Purpose

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; 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 (24 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 Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily) in Patients With Mild to Moderate Asthma

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
time to the first asthma exacerbation.

Secondary Outcome Measures:

FVC
asthma symptom score
use of rescue medication
AQLQ(S) and EQ-5D
percentage of days on which patients perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
physical examination
vital signs
standard laboratory work-up
adverse events
number of patients with local oropharyngeal adverse events.

Estimated Enrollment:	480
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Outpatients
Written informed consent
History of bronchial asthma for at least 6 months
Good health with the exception of asthma
Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
FEV1 80 - 105% of predicted

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
Current smoking with more than 10 pack-years
Previous smoking with more than 10 pack-years
Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
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: NCT00163423

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Locations

Austria
Altana Pharma/Nycomed
Wiener Neustadt, Austria, 2700
Altana Pharma/Nycomed
Gmünd, Austria, 3950
Altana Pharma/Nycomed
Linz, Austria, 4020
Altana Pharma/Nycomed
Steyr, Austria, 4400
Altana Pharma/Nycomed
Perg, Austria, 4320
Altana Pharma/Nycomed
Linz, Austria, 4040
Altana Pharma/Nycomed
Neusiedl/See, Austria, 7100
Canada
Altana Pharma/Nycomed
Ste-Foy PQ, Canada, G1V 4M6
Altana Pharma/Nycomed
Sainte-Foy, Quebec, Canada, G1V4G5
Altana Pharma/Nycomed
Quebec City, Canada, G8T 7A1
Altana Pharma/Nycomed
Montreal, Quebec, Canada, H1V 1X5
Altana Pharma/Nycomed
Montreal, Canada, H2L 4M1
Altana Pharma/Nycomed
Montreal, Canada, H4J1C5
Altana Pharma/Nycomed
Ottawa, Canada, K1Y 4G2
Altana Pharma/Nycomed
Mississauga, Canada, L5B 1N1
Altana Pharma/Nycomed
Hamilton, Canada, L8N 3Z5
Altana Pharma/Nycomed
London, Canada, N5W 6A2
Altana Pharma/Nycomed
Woodstock, Canada, N4S 4G3
Altana Pharma/Nycomed
Toronto, Canada, M4P1P2
Altana Pharma/Nycomed
London, Canada, N6C 4Y7
Altana Pharma/Nycomed
Sarnia, Canada, N7T 4X3
Altana Pharma/Nycomed
Brandon, Canada, R7A 5E7
Germany
Altana Pharma/Nycomed
Geesthacht, Germany, 21502
Altana Pharma/Nycomed
Hannover, Germany, 30167
Altana Pharma/Nycomed
Marburg, Germany, 35037
Altana Pharma/Nycomed
Mainz, Germany, 55131
Altana Pharma/Nycomed
Koblenz, Germany, 56068
Altana Pharma/Nycomed
Witten, Germany, 58452
Altana Pharma/Nycomed
Heidelberg, Germany, 69117
Altana Pharma/Nycomed
Sinsheim, Germany, 74889
Poland
Altana Pharma/Nycomed
Lublin, Poland, 20-718
Altana Pharma/Nycomed
Lublin, Poland, 20601
Altana Pharma/Nycomed
Zgierz, Poland, 95100
Altana Pharma/Nycomed
Walbrzych, Poland, 58300
Altana Pharma/Nycomed
Lubin, Poland, 59300
Altana Pharma/Nycomed
Gdansk, Poland, 80-847
Altana Pharma/Nycomed
Lodz, Poland, 90-141
Altana Pharma/Nycomed
Bielsko-Biala, Poland, 43316
South Africa
Altana Pharma/Nycomed
Wynberg, South Africa, 7945
Altana Pharma/Nycomed
Lyttleton, South Africa, 140
Altana Pharma/Nycomed
Pretoria, South Africa, 181
Altana Pharma/Nycomed
Pretoria, South Africa, 2
Altana Pharma/Nycomed
Westville, South Africa, 3630
Altana Pharma/Nycomed
Cape Town, Tygerberg, South Africa, 7505
Altana Pharma/Nycomed
Bellville, Cape Town, South Africa, 7530
Altana Pharma/Nycomed
Durbanville / Cape Town, South Africa, 7550
Altana Pharma/Nycomed
Cape Town, South Africa, 7764
Altana Pharma/Nycomed
Gatesville, Cape Town, South Africa, 7764
Altana Pharma/Nycomed
Mowbray, Cape Town, South Africa, 7925
Altana Pharma/Nycomed
Observatory Cape, South Africa, 7925
Altana Pharma/Nycomed
Arcadia, Pretoria, South Africa, 132

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Ronald Dahl, Prof.

Aarhus University Hospital, Aarhus, Denmark

More Information

No publications provided

Study ID Numbers:	BY9010/M1-142
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163423 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Fluticasone propionate

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 25, 2009