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.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163332
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


Further study details as provided by Takeda:

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
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: NCT00163332

Locations
Belgium
Altana Pharma/Nycomed
Genk, Belgium, 3600
Altana Pharma/Nycomed
Ghent, Belgium, 9000
Altana Pharma/Nycomed
Lanaken, Belgium, 3620
Altana Pharma/Nycomed
Liege, Belgium, 4000
Altana Pharma/Nycomed
Liége, Belgium, 4000
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: E. Derom, Professor State University, Ghent, Belgium
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163332     History of Changes
Other Study ID Numbers: BY9010/M1-129
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
Ciclesonide
Fluticasone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 19, 2014