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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00163397 |
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 |
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 |
Estimated Enrollment: | 120 |
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:
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 |
Study Chair: | Jeyaindran Sinnadurai, MD | Hospital Kuala Lumpur, Kuala Lumpur, Malaysia |
Study Chair: | Reury-Perng Perng, MD | Veterans General Hospital, Taipei, Taiwan |
Study ID Numbers: | BY9010/M1-137 |
Study First Received: | September 12, 2005 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00163397 History of Changes |
Health Authority: | Taiwan: Department of Health |
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 |