Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00327197 |
To evaluate and compare the expression and change in expression of key severe asthma targets at baseline in mile to moderate asthmatics vs. severe asthmatic subjects. To evaluate and compare the airway pathology at baseline and changes in airway pathology in relation to asthma severity.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Prednisolone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Pharmacodynamics Study |
Official Title: | A Study to Assess Disease Pathology and Key Therapeutic Targets in Severe Asthma |
Estimated Enrollment: | 50 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
In addition, the following additional exclusion criteria must apply to mild to moderate persistent asthmatics on regular inhaled steroids:
In addition, the following additional exclusion criteria must apply to severe persistent asthmatics with clinical controlled asthma symptoms:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United Kingdom, Leicestershire | |
GSK Investigational Site | Recruiting |
Leicester, Leicestershire, United Kingdom, LE3 9QP |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | RES100769 |
Study First Received: | May 17, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00327197 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Prednisolone Asthma bronchoscopy Sputum induction biomarkers |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Bronchial Diseases Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Asthma Methylprednisolone acetate Prednisolone acetate Neuroprotective Agents |
Hormones Glucocorticoids Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Prednisolone Hypersensitivity, Immediate Peripheral Nervous System Agents Respiratory Hypersensitivity Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Bronchial Diseases Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Methylprednisolone Hemisuccinate |
Immune System Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Methylprednisolone acetate Asthma Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Prednisolone Hypersensitivity, Immediate Peripheral Nervous System Agents Central Nervous System Agents Respiratory Hypersensitivity |