Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

This study has been completed.

First Received: September 12, 2005 Last Updated: July 16, 2008 History of Changes

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163332

Purpose

The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 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, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Comparison of Inhaled Ciclesonide (160 Mcg b.i.d. or 320 Mcg b.i.d.) and Fluticasone Propionate (250 Mcg b.i.d. or 500 Mcg b.i.d.) in Pretreated 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:

AUC(0-24h)/24 h of serum cortisol level
24 h urinary cortisol excretion adjusted for creatinine.

Secondary Outcome Measures:

8 am measurement of bone formation markers
PC20FEV1 to methacholine
PC20FEV1 to AMP
lung function (FEV1, FVC)
pharmacokinetics
safety and tolerability.

Estimated Enrollment:	30
Study Start Date:	March 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Patients who have had a history of bronchial asthma for at least 6 months
FEV1 >60% of predicted for at least 24 h
Patients who are hyperresponsive to methacholine and to AMP
Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Patients suffering from COPD and/or other relevant lung diseases except asthma
Current smokers and ex-smokers both with ≥10 pack years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163332

Locations

Belgium
Altana Pharma/Nycomed
Genk, Belgium, 3600
Altana Pharma/Nycomed
Lanaken, Belgium, 3620
Altana Pharma/Nycomed
Liege, Belgium, 4000
Altana Pharma/Nycomed
Liége, Belgium, 4000
Altana Pharma/Nycomed
Ghent, Belgium, 9000

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

E. Derom, Professor

State University, Ghent, Belgium

More Information

No publications provided

Study ID Numbers:	BY9010/M1-129
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163332 History of Changes
Health Authority:	Belgium: Ministère fédéral des Affaires sociales, de la Santé publique et de l'Environnement

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 February 08, 2010