Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318747
Status:
TERMINATED
Last Update Posted:
2013-02-05
First Post:
2006-04-25
Brief Title:
Treatment of Ragweed-Allergic Asthma With an Immunostimulatory Drug
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Asthma Immunotherapy With a Ragweed Allergen Immunostimulatory Sequence Conjugate
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the effectiveness of an investigational treatment for patients with ragweed-induced asthma sometimes called fall seasonal asthma The treatment being tested is a series of anti-ragweed shots The purpose of the study is to determine whether a short series of injections with Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate AIC can cause a long-lasting reduction in the symptoms of asthma that are caused by fall hay fever allergies
Detailed Description:
Ragweed allergy is a common trigger of asthmatic flare-ups in people with asthma Individuals with ragweed allergy suffer increased asthma symptoms during the fall allergy season which generally runs from August to November These flare-ups can significantly impact an asthma patients quality of life AIC is an investigational medicine that combines special DNA sequences that can modify the way the immune system responds In AIC these sequences are linked to a piece of the ragweed pollen molecule known as Amb a 1 that causes hay fever symptoms Injections of AIC have been shown to change the way the immune system responds to ragweed pollen in both animals and humans in a way that may lead to reduced hay fever symptoms
In a previous study AIC was safe and well tolerated and patients exhibited a decrease in allergy symptoms lasting up to 2 years after treatment on average This study will evaluate whether short-term use of AIC during the spring can cause long-term immune tolerance to ragweed reduce asthma symptoms and decrease use of asthma medications for future allergy seasons
During the 2007 fall ragweed allergy season participants will be observed and be asked to keep a diary of their asthma symptoms and medication use In the spring of 2008 participants will be randomly assigned to receive six weekly doses of either the experimental medicine or placebo Participants will be observed again for the 2008 fall ragweed season Another series of three weekly doses of the assigned study treatment will be given in spring 2009 with observation through the 2009 fall ragweed allergy season and possibly the 2010 season During the observation periods participants will be asked to track their asthma symptoms and medication use and report this information to study staff Study visits will be weekly during the spring and biweekly during the ragweed season with a maximum of 16 visits per year Allergy and lung tests as well as blood and urine collection will occur at selected study visits these tests are designed to measure the participants immune response
In a previous study AIC was safe and well tolerated and patients exhibited a decrease in allergy symptoms lasting up to 2 years after treatment on average This study will evaluate whether short-term use of AIC during the spring can cause long-term immune tolerance to ragweed reduce asthma symptoms and decrease use of asthma medications for future allergy seasons
During the 2007 fall ragweed allergy season participants will be observed and be asked to keep a diary of their asthma symptoms and medication use In the spring of 2008 participants will be randomly assigned to receive six weekly doses of either the experimental medicine or placebo Participants will be observed again for the 2008 fall ragweed season Another series of three weekly doses of the assigned study treatment will be given in spring 2009 with observation through the 2009 fall ragweed allergy season and possibly the 2010 season During the observation periods participants will be asked to track their asthma symptoms and medication use and report this information to study staff Study visits will be weekly during the spring and biweekly during the ragweed season with a maximum of 16 visits per year Allergy and lung tests as well as blood and urine collection will occur at selected study visits these tests are designed to measure the participants immune response
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