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

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163319

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Comparison of Inhaled Ciclesonide (640 Mcg/Day) and Fluticasone Propionate (1000 Mcg/Day) in Patients With Moderate and Severe Persistent Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Yeast Infections

Drug Information available for: Fluticasone propionate Fluticasone Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

number of patients with candidiasis of the oropharynx or hoarseness.

Secondary Outcome Measures:

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

Estimated Enrollment:	500
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163319

Show 89 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Daniel Dusser, MD, PhD

Hospital COCHIN, Paris, France

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00163319 History of Changes
Other Study ID Numbers:	BY9010/IT-101
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
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:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Ciclesonide

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012