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Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)
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: NCT00163384
  Purpose

This trial will compare the effectiveness of one dose of ciclesonide against one dose of budesonide in patients with asthma. The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset of action and the safety and tolerability of ciclesonide in comparison to budesonide will also be investigated.


Condition Intervention Phase
Asthma
Drug: Ciclesonide
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo 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

Resource links provided by NLM:


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).

Estimated Enrollment: 240
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 (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: NCT00163384

Locations
Korea, Republic of
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 120-749
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 133-792
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 134-701
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 135-710
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 137-701
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 138-736
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 140-757
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 158-710
Altana Pharma/Nycomed
Gangwon-do, Korea, Republic of, 220-701
Altana Pharma/Nycomed
Daegu, Korea, Republic of, 700-721
Altana Pharma/Nycomed
Chungnam, Korea, Republic of, 330-715
Altana Pharma/Nycomed
Chungbuk, Korea, Republic of, 361-711
Altana Pharma/Nycomed
Gyeonggi-do, Korea, Republic of, 420-767
Altana Pharma/Nycomed
Gyeonggi-do, Korea, Republic of, 442-721
Altana Pharma/Nycomed
Gwangju, Korea, Republic of, 501-757
Altana Pharma/Nycomed
Jeonju, Korea, Republic of, 561-712
Altana Pharma/Nycomed
Busan, Korea, Republic of, 602-715
Altana Pharma/Nycomed
Daegu, Korea, Republic of, 700-712
Altana Pharma/Nycomed
Daejeon, Korea, Republic of, 301-721
Sponsors and Collaborators
ALTANA Pharma
Investigators
Principal Investigator: Sung-Hak Park, Prof. The Catholic University of Korea, Kangnam St. Mary's Hospital, Seoul, Korea
  More Information

No publications provided

Study ID Numbers: BY9010/M1-136
Study First Received: September 12, 2005
Last Updated: July 16, 2008
ClinicalTrials.gov Identifier: NCT00163384     History of Changes
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by ALTANA Pharma:
Asthma
Ciclesonide
Budesonide

Study placed in the following topic categories:
Anti-Inflammatory Agents
Bronchial Diseases
Hormone Antagonists
Ciclesonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Hormones
Glucocorticoids
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009