Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001408
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Role of T-Cells in Asthma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cytokine Expression in Allergic Asthma
Status:
COMPLETED
Status Verified Date:
2009-06-25
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:
This study will examine the movement of T cells a type of white blood cell from the blood to the lungs in patients with asthma after exposure to an allergen such as cat dander or pollen Asthma is in large part due to inflammation of the bronchi the breathing tubes of the lungs causing heat swelling and redness T cells play a major role in the inflammatory reaction A better understanding of T cell migration to the lungs after allergen exposure may lead to improved therapies for asthma
Patients between 18 and 50 years of age with mild allergic asthma may be eligible for this study In addition patients and healthy normal volunteers between 18 and 65 years of age may participate in a sub-study blood draw of this protocol Participants will undergo the following procedures
Visit 1 screening visit
Blood tests for blood counts and HIV
Urine pregnancy test for women of childbearing potential
Visit 2
Physical examination and electrocardiogram EKG
Prick skin testing - A drop of allergen extract is put on the skin and the underlying skin is scratched with a needle A positive test resembles an insect bite and may itch
Intradermal skin tests - Increasing concentrations of a drop of diluted allergen are injected into the skin and the allergic response is monitored until a 5-mm swelling 14 inch swelling develops
Methacholine challenge - The subject has repeated pulmonary function breathing tests after breathing methacholine a drug that temporarily for 5 to 10 minutes worsens asthma symptoms
Physician evaluation and repeat pulmonary function test
Visit 3
- Allergen bronchoprovocation - This test will be done in patients whose physical evaluation and breathing test permit them to continue with the study A heparin lock needle device that stays in a vein to allow multiple blood draws without repeated sticks is placed The subject breathes 5 breaths of allergen through a nebulizer device that creates a mist followed by a breathing test This procedure will be repeated with increasingly higher allergen doses until lung function significantly declines or for a maximum of 6 doses Subjects are monitored for 8 hours after the last dose Blood samples of 50 ml each 35 tablespoons are collected at 1 3 5 and 8 hours and a physician evaluation is done at the end of the 8 hours Additional 50-mm blood samples are collected the following two mornings
Visit 4
Physician evaluation blood test for anemia and pulmonary function test
Serial blood draws - 50 ml of blood will be drawn followed by salt-water nebulization and another 50-ml blood draw after 1 hour Additional 50-ml blood samples will be drawn 7 hours later and then on the next two mornings
Participants in the sub-study portion of this protocol will undergo the screening blood test prick skin testing breathing test after methacholine inhalation and a 100 ml-blood draw These tests will be done in three sessions
Patients between 18 and 50 years of age with mild allergic asthma may be eligible for this study In addition patients and healthy normal volunteers between 18 and 65 years of age may participate in a sub-study blood draw of this protocol Participants will undergo the following procedures
Visit 1 screening visit
Blood tests for blood counts and HIV
Urine pregnancy test for women of childbearing potential
Visit 2
Physical examination and electrocardiogram EKG
Prick skin testing - A drop of allergen extract is put on the skin and the underlying skin is scratched with a needle A positive test resembles an insect bite and may itch
Intradermal skin tests - Increasing concentrations of a drop of diluted allergen are injected into the skin and the allergic response is monitored until a 5-mm swelling 14 inch swelling develops
Methacholine challenge - The subject has repeated pulmonary function breathing tests after breathing methacholine a drug that temporarily for 5 to 10 minutes worsens asthma symptoms
Physician evaluation and repeat pulmonary function test
Visit 3
- Allergen bronchoprovocation - This test will be done in patients whose physical evaluation and breathing test permit them to continue with the study A heparin lock needle device that stays in a vein to allow multiple blood draws without repeated sticks is placed The subject breathes 5 breaths of allergen through a nebulizer device that creates a mist followed by a breathing test This procedure will be repeated with increasingly higher allergen doses until lung function significantly declines or for a maximum of 6 doses Subjects are monitored for 8 hours after the last dose Blood samples of 50 ml each 35 tablespoons are collected at 1 3 5 and 8 hours and a physician evaluation is done at the end of the 8 hours Additional 50-mm blood samples are collected the following two mornings
Visit 4
Physician evaluation blood test for anemia and pulmonary function test
Serial blood draws - 50 ml of blood will be drawn followed by salt-water nebulization and another 50-ml blood draw after 1 hour Additional 50-ml blood samples will be drawn 7 hours later and then on the next two mornings
Participants in the sub-study portion of this protocol will undergo the screening blood test prick skin testing breathing test after methacholine inhalation and a 100 ml-blood draw These tests will be done in three sessions
Detailed Description:
In the last 10 years it has become generally accepted that asthma is an inflammatory disease of the airways T lymphocytes play a key role in regulating this inflammatory response through the elaboration of cytokines such as IL-4 IL-5 and IFN-gamma IL-5 is of particular interest because it is the major eosinophil survival factor in vivo Eosinophils are felt to be the major effector cells in asthma causing damage to various airway structures
The pulmonary late phase response a worsening of airflow seen 4-8 hours after allergen inhalation is associated with many of the inflammatory changes seen in chronic asthma Current studies suggest that during the late phase response peripheral blood T cells traffic to the lungs and express cytokines specifically IL-4 and IL-5
We propose to investigate this trafficking by determining the frequencies and phenotype of cells capable of producing the above cytokines in the peripheral blood in subjects with mild allergic asthma These studies should lead to a clearer understanding of the cells and processes that lead to T cell trafficking to the lung and may yield a tool to evaluate the proposed anti-inflammatory therapies for asthma
The pulmonary late phase response a worsening of airflow seen 4-8 hours after allergen inhalation is associated with many of the inflammatory changes seen in chronic asthma Current studies suggest that during the late phase response peripheral blood T cells traffic to the lungs and express cytokines specifically IL-4 and IL-5
We propose to investigate this trafficking by determining the frequencies and phenotype of cells capable of producing the above cytokines in the peripheral blood in subjects with mild allergic asthma These studies should lead to a clearer understanding of the cells and processes that lead to T cell trafficking to the lung and may yield a tool to evaluate the proposed anti-inflammatory therapies for asthma
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 |
|---|---|---|---|
| 94-I-0203 | None | None | None |