NCT00318747

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

First QC Date

April 25, 2006

Last Update Submit

February 1, 2013

Conditions

AsthmaAllergyAllergic RhinitisRhinitis, Allergic, Seasonal

Keywords

Amb a 1-Immunostimulatory Oligodeoxyribonucleotide ConjugateAICAmb a I ProteinRagweed AllergyHay FeverWheezeImmunotherapyToleranceImmunostimulatoryRagweed SeasonAsthmaAsthmaticsAsthmatic

Outcome Measures

Primary Outcomes (1)

  • Change in average daily asthma medication use between the 2007 and 2008 ragweed seasons

Secondary Outcomes (3)

  • Effect of AIC on selected secondary clinical outcome measures

  • safety of AIC in this population

  • mechanisms through which AIC may induce tolerance to ragweed

Interventions

Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Bernstein Clinical Research Center, University of Cincinnati

Cincinnati, Ohio, 452323, United States

Location

Optimed Research, Ohio State University

Columbus, Ohio, 43235, United States

Location

Pennsylvania State University

Hershey, Pennsylvania, 71033, United States

Location

Related Publications (2)

  • Simons FE, Shikishima Y, Van Nest G, Eiden JJ, HayGlass KT. Selective immune redirection in humans with ragweed allergy by injecting Amb a 1 linked to immunostimulatory DNA. J Allergy Clin Immunol. 2004 Jun;113(6):1144-51. doi: 10.1016/j.jaci.2004.03.003.

    PMID: 15208597BACKGROUND

  • Tulic MK, Fiset PO, Christodoulopoulos P, Vaillancourt P, Desrosiers M, Lavigne F, Eiden J, Hamid Q. Amb a 1-immunostimulatory oligodeoxynucleotide conjugate immunotherapy decreases the nasal inflammatory response. J Allergy Clin Immunol. 2004 Feb;113(2):235-41. doi: 10.1016/j.jaci.2003.11.001.

    PMID: 14767435BACKGROUND

Related Links

MeSH Terms

Conditions

AsthmaHypersensitivityRhinitis, AllergicRhinitis, Allergic, SeasonalRespiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Broide, MD

    University of California, San Diego

    STUDY CHAIR

  • Peter Creticos, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

April 1, 2006

Study Completion

November 1, 2006

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(4)