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Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)

This study has been completed.

Sponsored by: ALTANA Pharma
Information provided by: ALTANA Pharma
ClinicalTrials.gov Identifier: NCT00163397
  Purpose

The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Condition Intervention Phase
Asthma
Drug: Ciclesonide
Phase III

MedlinePlus related topics:   Asthma   

ChemIDplus related topics:   Ciclesonide    Budesonide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Comparative Study of Inhaled Ciclesonide 160 Mcg/Day vs Budesonide 400 Mcg/Day in Patients With Asthma

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:
  • FEV1 absolute values.

Secondary Outcome Measures:
  • FEV1 as percent of predicted
  • FVC
  • PEF absolute values
  • morning and evening PEF from diary
  • diurnal PEF fluctuation
  • asthma symptom score from diary
  • use of rescue medication from diary
  • number of symptom free- and rescue medication free days
  • dropout rate due to asthma exacerbations
  • time until first asthma exacerbation
  • number of days with asthma control
  • onset of effect
  • subgroup analysis for ex/current smokers and non-smokers
  • AQLQ(S)
  • physical examination
  • vital signs
  • laboratory work-up
  • adverse events.

Estimated Enrollment:   120
Study Start Date:   January 2004

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

Criteria

Main Inclusion Criteria:

  • During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
  • FEV1 80 - 105% of predicted
  • Healthy with the exception of asthma
  • Written informed consent has been obtained
  • Outpatients
  • Patients who have a history of persistent bronchial asthma for at least 6 months

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
  • Patient is current smoker with 10 or more pack-years
  • Patient is ex-smoker with 10 or more pack-years
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163397

Locations
Malaysia
Altana Pharma/Nycomed    
      Kota Bharu / Kelantan, Malaysia, 16150
Altana Pharma/Nycomed    
      Kuala Lumpur, Malaysia, 50586
Altana Pharma/Nycomed    
      Kuala Lumpur, Malaysia, 50603
Altana Pharma/Nycomed    
      Kuala Lumpur, Malaysia, 56000
Taiwan
Altana Pharma/Nycomed    
      Taipei, Taiwan
Altana Pharma/Nycomed    
      Taipei City 114, Taiwan, 886-114

Sponsors and Collaborators
ALTANA Pharma

Investigators
Study Chair:     Jeyaindran Sinnadurai, MD     Hospital Kuala Lumpur, Kuala Lumpur, Malaysia    
Study Chair:     Reury-Perng Perng, MD     Veterans General Hospital, Taipei, Taiwan    
  More Information


Study ID Numbers:   BY9010/M1-137
First Received:   September 12, 2005
Last Updated:   July 16, 2008
ClinicalTrials.gov Identifier:   NCT00163397
Health Authority:   Taiwan: Department of Health

Keywords provided by ALTANA Pharma:
Asthma  
Ciclesonide  
Budesonide  

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Ciclesonide
Lung Diseases
Budesonide
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 19, 2008




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