AllergyNCT00405899
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
An observational study of Allergy and Seasonal Allergic Rhinitis, run by West Penn Allegheny Health System at 1 site in United States.
Trial summary
The objective of this study is to determine whether there is a relationship between interferon-gamma levels and the incidence of viral respiratory infections in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care (nasal steroids, antihistamines) over a 1-year… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Allergy, Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2009
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and Female patients aged 6 to 18 years being treated for allergies.
Who may be able to join
- Age 6-18 years of age
- History of allergic rhinitis as confirmed by previous allergy skin testing conducted within the past year
- Subjects assigned to the allergy immunotherapy must be prescribed therapy according to national recommendations using FDA-approved allergy extracts supplied by Greer Laboratories
Who cannot join
- Concurrent difficult to control asthma or an underlying immune deficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
The objective of this study is to determine whether there is a relationship between interferon-gamma levels and the incidence of viral respiratory infections in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care, 2) the incidence of viral respiratory infections will be reduced at 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care.
Read the detailed description
This study will consist of five visits. Visit 1 will occur after subjects complete an initial clinical evaluation for allergy at this site. Subjects will select their treatment (allergy immunotherapy as compared to standard medical care) prior to enrollment in this study.
Visit 1 will include informed consent, review of inclusion and exclusion criteria and phlebotomy for the determination of serum interferon-gamma levels. At the end of this visit, diary cards to capture the frequency of symptoms of viral respiratory infections will be distributed. Visits 2-5 will occur 3, 6, 9 and 12 months after visit 1 and will include review/exchange of diary cards, and phlebotomy for determination of serial serum interferon-gamma levels.
- Keywords
- Allergy, Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy | Patients starting immunotherapy | |
| Non-immunotherapy | Patients being treated using methods other than immunotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startOct 2006
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Allergy and Asthma Research Foundation
- Investigators
- Deborah Gentile, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405899
- Sponsor's protocol ID
- RC - 4064
- Status last verified
- May 2010
- First submitted
- 28 Nov 2006
- Last updated
- 31 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
- ClinicalTrials.gov ID
- NCT00405899
- Acronym / sponsor ID
- RC - 4064
- Keywords
- Allergy, Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Collaborators
- Pennsylvania Allergy and Asthma Research Foundation
- Study start
- Oct 2006
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Nov 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.
The objective of this study is to determine whether there is a relationship between interferon-gamma levels and the incidence of viral respiratory infections in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care, 2) the incidence of viral respiratory infections will be reduced at 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care.
Detailed description
This study will consist of five visits. Visit 1 will occur after subjects complete an initial clinical evaluation for allergy at this site. Subjects will select their treatment (allergy immunotherapy as compared to standard medical care) prior to enrollment in this study.
Visit 1 will include informed consent, review of inclusion and exclusion criteria and phlebotomy for the determination of serum interferon-gamma levels. At the end of this visit, diary cards to capture the frequency of symptoms of viral respiratory infections will be distributed. Visits 2-5 will occur 3, 6, 9 and 12 months after visit 1 and will include review/exchange of diary cards, and phlebotomy for determination of serial serum interferon-gamma levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy | – | –Patients starting immunotherapy |
| Non-immunotherapy | – | –Patients being treated using methods other than immunotherapy |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and Female patients aged 6 to 18 years being treated for allergies.
Key inclusion criteria (3 listed)
- Age 6-18 years of age
- History of allergic rhinitis as confirmed by previous allergy skin testing conducted within the past year
- Subjects assigned to the allergy immunotherapy must be prescribed therapy according to national recommendations using FDA-approved allergy extracts supplied by Greer Laboratories
Key exclusion criteria (1 listed)
- Concurrent difficult to control asthma or an underlying immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2010.
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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.
Deborah Gentile, MD principal investigator
West Penn Allegheny Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy and Seasonal Allergic Rhinitis, run by West Penn Allegheny Health System at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 31 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 31 May 2010.