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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.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163319
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
History of Changes
  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 3

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:

U.S. FDA Resources

Further study details as provided by Takeda:

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
Takeda
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: May 4, 2012
Health Authority: Belgium: Ministère fédéral des Affaires sociales, de la Santé publique et de l'Environnement

Keywords provided by Takeda:
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 June 18, 2013