Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217854
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2005-09-19
Brief Title:
Inflammatory Processes in the Airway of Asthmatics With Persistent Bronchial Hyperreactivity
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Mechanisms of Airway Inflammation Natural Exacerbation of Asthma Induced by Glucocorticoid Withdrawal
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine inflammatory processes in the airway of moderate to severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic administration of inhaled glucocorticoids
Detailed Description:
BACKGROUND
The Inhaled Glucocorticoid Withdrawal Protocol will investigate abnormalities in the asthmatic airway that occur in the setting of a natural endogenous exacerbation It is known that chronic treatment with inhaled glucocorticoids causes a nearly complete disappearance of inflammatory cells from the airway and improvement in bronchial hyperreactivity yet such patients have persistent bronchial hyperreactivity Withdrawal of inhaled glucocorticoids causes a worsening of bronchial hyperreactivity These observations suggest that a chronic derangement in the asthmatic airway might exist which is unmasked by withdrawal of inhaled glucocorticoids and which reinitiates the inflammatory process These persistent abnormalities in the asthmatic airway may be seen during quiescent stages of chronic asthma even when airway inflammatory changes are not evident The abnormalities may be seen during the period of treatment with inhaled glucocorticoids or they may appear as one of the first signs after the withdrawal of inhaled glucocorticoids thereby initiating the recurrence of asthma and promoting inflammation
DESIGN NARRATIVE
The purpose of this study is to examine inflammatory processes in the airway of moderate to severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic administration of inhaled glucocorticoids Each participant will undergo bronchoscopic procedures and have assessment of bronchial hyperreactivity at the following two time points 1 during treatment with inhaled fluticasone and 2 after acute withdrawal of inhaled fluticasone
The primary outcome of this study is the change in CD3 positive T cells in the airway submucosa
The key secondary outcomes are as follows 1 other inflammatory cell markers in the airway eg CD4 CD8 CD68 CD45 EG2MBP tryptase and neutrophil elastase 2 RANTES regulated on activation normal T expressed and secreted expression in airway 3 FEV1 peak expiratory flows 4 methacholine PC20 and 5 asthma symptom score
The Inhaled Glucocorticoid Withdrawal Protocol will investigate abnormalities in the asthmatic airway that occur in the setting of a natural endogenous exacerbation It is known that chronic treatment with inhaled glucocorticoids causes a nearly complete disappearance of inflammatory cells from the airway and improvement in bronchial hyperreactivity yet such patients have persistent bronchial hyperreactivity Withdrawal of inhaled glucocorticoids causes a worsening of bronchial hyperreactivity These observations suggest that a chronic derangement in the asthmatic airway might exist which is unmasked by withdrawal of inhaled glucocorticoids and which reinitiates the inflammatory process These persistent abnormalities in the asthmatic airway may be seen during quiescent stages of chronic asthma even when airway inflammatory changes are not evident The abnormalities may be seen during the period of treatment with inhaled glucocorticoids or they may appear as one of the first signs after the withdrawal of inhaled glucocorticoids thereby initiating the recurrence of asthma and promoting inflammation
DESIGN NARRATIVE
The purpose of this study is to examine inflammatory processes in the airway of moderate to severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic administration of inhaled glucocorticoids Each participant will undergo bronchoscopic procedures and have assessment of bronchial hyperreactivity at the following two time points 1 during treatment with inhaled fluticasone and 2 after acute withdrawal of inhaled fluticasone
The primary outcome of this study is the change in CD3 positive T cells in the airway submucosa
The key secondary outcomes are as follows 1 other inflammatory cell markers in the airway eg CD4 CD8 CD68 CD45 EG2MBP tryptase and neutrophil elastase 2 RANTES regulated on activation normal T expressed and secreted expression in airway 3 FEV1 peak expiratory flows 4 methacholine PC20 and 5 asthma symptom score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL056419 | NIH | None | httpsreporternihgovquickSearchP50HL056419 |