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| Sponsor: | Horizon Pharma, Inc. |
|---|---|
| Information provided by: | Horizon Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT00686335 |
Purpose
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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma |
| Enrollment: | 12 |
| Study Start Date: | June 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | Chief Medical Officier, Horizon Pharma |
| ClinicalTrials.gov Identifier: | NCT00686335 History of Changes |
| Other Study ID Numbers: | NP01-201, EudraCT-Number: 2007-007316-29 |
| Study First Received: | May 26, 2008 |
| Last Updated: | March 15, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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asthma nocturnal asthma glucocorticoid dependent persistent asthma |
signs and symptoms lung function prednisone |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Prednisone |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |