AsthmaPhase 2NCT00318747
Treatment of Ragweed-Allergic Asthma With an Immunostimulatory Drug
A Phase 2 study testing Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC) in people with Asthma and Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Allergy, Allergic Rhinitis
- What is being tested?
- Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2006to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of asthma
- History of asthma medication use during the 2005 fall ragweed season
- Suspected ragweed allergy
- Positive laboratory tests for ragweed allergy
Who cannot join
- 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
Show all 9Show fewer
- Greater than 5 pack/year history of smoking
- Clinically significant acute or chronic illness
- Chronic immunodeficiency
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Bernstein Clinical Research Center, University of Cincinnati
Cincinnati, Ohio, 452323
Optimed Research, Ohio State University
Columbus, Ohio, 43235
Pennsylvania State University
Hershey, Pennsylvania, 71033
About this study
Official title: Asthma Immunotherapy With a Ragweed Allergen Immunostimulatory Sequence Conjugate
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.
Read the 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.
- Conditions
- Asthma, Allergy, Allergic Rhinitis, Rhinitis, Allergic, Seasonal
- Being tested
- Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)
- Keywords
- Amb a 1-Immunostimulatory Oligodeoxyribonucleotide Conjugate, AIC, Amb a I Protein, Ragweed Allergy, Hay Fever, Wheeze, Immunotherapy, Tolerance, Immunostimulatory, Ragweed Season, Asthma, Asthmatics, Asthmatic
- Medical subject headings
- Asthma, Hypersensitivity, Rhinitis, Allergic, Rhinitis, Allergic, Seasonal, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2006
- Study completionNov 2006
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- David Broide, MD, Study chair, University of California, San DiegoPeter Creticos, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318747
- Sponsor's protocol ID
- DAIT ITN031AD
- Status last verified
- Feb 2013
- First submitted
- 25 Apr 2006
- Last updated
- 5 Feb 2013
- Results posted
- No
Publications
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.
PubMed 15208597Tulic 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.
PubMed 14767435
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Immunotherapy With a Ragweed Allergen Immunostimulatory Sequence Conjugate
- ClinicalTrials.gov ID
- NCT00318747
- Acronym / sponsor ID
- DAIT ITN031AD
- Conditions
- Asthma, Allergy, Allergic Rhinitis, Rhinitis, Allergic, Seasonal
- Keywords
- Amb a 1-Immunostimulatory Oligodeoxyribonucleotide Conjugate, AIC, Amb a I Protein, Ragweed Allergy, Hay Fever, Wheeze, Immunotherapy, Tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 140 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- Apr 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of asthma
- History of asthma medication use during the 2005 fall ragweed season
- Suspected ragweed allergy
- Positive laboratory tests for ragweed allergy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC) | Drug | – |
Primary outcome
Change in average daily asthma medication use between the 2007 and 2008 ragweed seasons
3 secondary outcomes
Effect of AIC on selected secondary clinical outcome measures
safety of AIC in this population
mechanisms through which AIC may induce tolerance to ragweed
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Background: PubMed 15208597Simons 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.
- Background: PubMed 14767435Tulic 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.
- Click here for the Immune Tolerance Network Web siteLink provided by the sponsor.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Broide, MD study chair
University of California, San Diego
Peter Creticos, MD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC) in people with Asthma and Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average daily asthma medication use between the 2007 and 2008 ragweed seasons. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00318747, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.