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Sponsored by: |
Nitec Pharma AG |
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Information provided by: | Nitec Pharma AG |
ClinicalTrials.gov Identifier: | NCT00686335 |
The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: modified release tablet formulation of prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma |
Estimated Enrollment: | 10 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Poorly controlled asthma, defined as meeting at least one of the following within the 4 weeks prior to Visit V0:
Contact: Nitec Pharma | mona@nitecpharma.com |
France | |
Hôpital Bichat | Recruiting |
Paris, France, 75018 |
Principal Investigator: | Michel Aubier, Prof. Dr. | Hôpital Bichat, Paris, France |
Responsible Party: | Nitec Pharma GmbH ( Chief Medical Officier ) |
Study ID Numbers: | NP01-201, EudraCT-Number: 2007-007316-29 |
Study First Received: | May 26, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00686335 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
asthma nocturnal asthma glucocorticoid dependent persistent asthma |
signs and symptoms lung function prednisone |
Prednisone Signs and Symptoms Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Immune System Diseases Bronchial Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |