Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021931
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2001-08-10
Brief Title:
Modification of Allergic Immunologic Response by Leukotriene Antagonists - Ancillary to ACRN IMPACT
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-07
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:
To examine the cellular and molecular mechanisms of corticosteroid and leukotriene receptor antagonists focusing on their effects on T lymphocytes during both chronic 18 months and acute therapy
Detailed Description:
BACKGROUND
Asthma is a chronic inflammatory disease T lymphocytes are essential for initiating and maintaining the asthmatic inflammatory immune response Corticosteroid treatment targets several inflammatory responses including T lymphocytemediated responses In addition leukotriene receptor antagonists LTRA may influence T cell activation To investigate the effects of these two controller agents in the treatment of asthma on airway function is the goal of the IMPACT clinical trial in mild chronic adult asthmatics The Improving Asthma Control Trial IMPACT is one of the trials within the NHLBI-supported Asthma Clinical Research Network ACRN IMPACT is a double-blind randomized parallel group design clinical trial to determine the best long-term strategy for treating adults with mild asthma who experience symptoms more than occasionally The trial will test whether these patients should be taking anti-inflammatory medications on a daily basis and whether a newer class of medications provides the same benefit as older drugs In the IMPACT study 234 adults with mild asthma who have more than occasional symptoms will be enrolled in six clinical research centers Following an initial evaluation patients will be randomized to receive either a twice daily inhaled corticosteroid a twice daily anti-leukotriene or a placebo All patients will receive treatment for symptoms if and when they occur The results should demonstrate whether medication is required on a daily basis by these patients and if so whether inhaled corticosteroids and leukotriene modifiers are equally effective Recruitment began in May 2000 The trial is expected to be completed in 2003
The study is in response to an initiative Ancillary Studies in Heart Lung and Blood Disease Trials released by the National Heart Lung and Blood Institute in June 2000
DESIGN NARRATIVE
A total of 39 patients 13 in each arm will be randomized to inhaled steroid leukotriene receptor antagonist or placebo and followed for 18 months for changes in T-cell costimulatory pathways
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Asthma is a chronic inflammatory disease T lymphocytes are essential for initiating and maintaining the asthmatic inflammatory immune response Corticosteroid treatment targets several inflammatory responses including T lymphocytemediated responses In addition leukotriene receptor antagonists LTRA may influence T cell activation To investigate the effects of these two controller agents in the treatment of asthma on airway function is the goal of the IMPACT clinical trial in mild chronic adult asthmatics The Improving Asthma Control Trial IMPACT is one of the trials within the NHLBI-supported Asthma Clinical Research Network ACRN IMPACT is a double-blind randomized parallel group design clinical trial to determine the best long-term strategy for treating adults with mild asthma who experience symptoms more than occasionally The trial will test whether these patients should be taking anti-inflammatory medications on a daily basis and whether a newer class of medications provides the same benefit as older drugs In the IMPACT study 234 adults with mild asthma who have more than occasional symptoms will be enrolled in six clinical research centers Following an initial evaluation patients will be randomized to receive either a twice daily inhaled corticosteroid a twice daily anti-leukotriene or a placebo All patients will receive treatment for symptoms if and when they occur The results should demonstrate whether medication is required on a daily basis by these patients and if so whether inhaled corticosteroids and leukotriene modifiers are equally effective Recruitment began in May 2000 The trial is expected to be completed in 2003
The study is in response to an initiative Ancillary Studies in Heart Lung and Blood Disease Trials released by the National Heart Lung and Blood Institute in June 2000
DESIGN NARRATIVE
A total of 39 patients 13 in each arm will be randomized to inhaled steroid leukotriene receptor antagonist or placebo and followed for 18 months for changes in T-cell costimulatory pathways
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL067684 | NIH | None | httpsreporternihgovquickSearchR01HL067684 |