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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00318747 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Allergy Allergic Rhinitis Rhinitis, Allergic, Seasonal |
Drug: Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Asthma Immunotherapy With a Ragweed Allergen Immunostimulatory Sequence Conjugate |
| Estimated Enrollment: | 140 |
| Study Start Date: | April 2006 |
| Study Completion Date: | November 2006 |
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 patient's 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Ohio | |
| Optimed Research, Ohio State University | |
| Columbus, Ohio, United States, 43235 | |
| Bernstein Clinical Research Center, University of Cincinnati | |
| Cincinnati, Ohio, United States, 452323 | |
| United States, Pennsylvania | |
| Pennsylvania State University | |
| Hershey, Pennsylvania, United States, 71033 | |
| Study Chair: | David Broide, MD | University of California, San Diego |
| Principal Investigator: | Peter Creticos, MD | Johns Hopkins University |
More Information
| Study ID Numbers: | ITN031AD |
| Study First Received: | April 25, 2006 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00318747 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Amb a 1-Immunostimulatory Oligodeoxyribonucleotide Conjugate AIC Amb a I Protein Ragweed Allergy Hay Fever Wheeze Immunotherapy |
Tolerance Immunostimulatory Ragweed Season Asthma Asthmatics Asthmatic |
|
Otorhinolaryngologic Diseases Bronchial Diseases Asthma Rhinitis Fever Hypersensitivity Lung Diseases, Obstructive |
Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |
|
Otorhinolaryngologic Diseases Bronchial Diseases Immune System Diseases Asthma Rhinitis Nose Diseases Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Seasonal Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |
