Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
This study has been completed.
First Received: September 12, 2005   Last Updated: July 16, 2008   History of Changes
Sponsored by: 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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Bronchial Diseases
Ciclesonide
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Lung Diseases, Obstructive
Hypersensitivity
 Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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 July 02, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services