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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00163384 |
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 |
Estimated Enrollment: | 240 |
Study Start Date: | January 2004 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
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 |
Principal Investigator: | Sung-Hak Park, Prof. | The Catholic University of Korea, Kangnam St. Mary's Hospital, Seoul, Korea |
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) |
Asthma Ciclesonide Budesonide |
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 |
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 |