Treatment of Ragweed-Allergic Asthma With an Immunostimulatory Drug

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00318747
First received: April 25, 2006
Last updated: February 1, 2013
Last verified: February 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Asthma Immunotherapy With a Ragweed Allergen Immunostimulatory Sequence Conjugate

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Change in average daily asthma medication use between the 2007 and 2008 ragweed seasons

Secondary Outcome Measures:
  • Effect of AIC on selected secondary clinical outcome measures
  • safety of AIC in this population
  • mechanisms through which AIC may induce tolerance to ragweed

Estimated Enrollment: 140
Study Start Date: April 2006
Study Completion Date: November 2006
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 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
Criteria

Inclusion Criteria:

  • History of asthma
  • History of asthma medication use during the 2005 fall ragweed season
  • Suspected ragweed allergy
  • Positive laboratory tests for ragweed allergy

Exclusion Criteria:

  • Received immunotherapy for ragweed or other allergens within the 5 years prior to study entry
  • Received anti-IgE (omalizumab) within the year prior to study entry
  • 3 or more courses of oral corticosteroids for asthma within the year prior to study entry
  • Inpatient hospitalization for asthma within the 5 years prior to study entry
  • History of respiratory failure or intubation for asthma
  • Smoking within the 6 months prior to study entry
  • Greater than 5 pack/year history of smoking
  • Clinically significant acute or chronic illness
  • Chronic immunodeficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318747

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Ohio
Bernstein Clinical Research Center, University of Cincinnati
Cincinnati, Ohio, United States, 452323
Optimed Research, Ohio State University
Columbus, Ohio, United States, 43235
United States, Pennsylvania
Pennsylvania State University
Hershey, Pennsylvania, United States, 71033
Sponsors and Collaborators
Immune Tolerance Network (ITN)
Investigators
Study Chair: David Broide, MD University of California, San Diego
Principal Investigator: Peter Creticos, MD Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00318747     History of Changes
Other Study ID Numbers: DAIT ITN031AD
Study First Received: April 25, 2006
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Amb a 1-Immunostimulatory Oligodeoxyribonucleotide Conjugate
AIC
Amb a I Protein
Ragweed Allergy
Hay Fever
Wheeze
Immunotherapy
Tolerance
Immunostimulatory
Ragweed Season
Asthma
Asthmatics
Asthmatic

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Rhinitis, Allergic, Seasonal
Rhinitis
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014