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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.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163384
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
  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 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: 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 Takeda:

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
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: NCT00163384

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

No publications provided

ClinicalTrials.gov Identifier: NCT00163384     History of Changes
Other Study ID Numbers: BY9010/M1-136
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Takeda:
Asthma
Ciclesonide
Budesonide

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

ClinicalTrials.gov processed this record on November 25, 2014