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.
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ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
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
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:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Sponsors and Collaborators
Principal Investigator: Daniel Dusser, MD, PhD Hospital COCHIN, Paris, France
  More Information

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:
Fluticasone propionate

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016