Perennial Allergic Rhinitis With Seasonal VariationNCT01699659
The Efficacy & Safety of the UAS Immunotherapy Protocol
An observational study of Perennial Allergic Rhinitis With Seasonal Variation, run by United Allergy Services at 1 site in United States.
Trial summary
Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Perennial Allergic Rhinitis With Seasonal Variation
- What is being tested?
- allergen immunotherapy
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2012
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with allergic rhinitis pre and post immunotherapy (1 to 2 years).
Who may be able to join
- Allergic rhinitis between 18 and 65 years old who have chosen to undergo immunotherapy.
Who cannot join
- No beta blocker use,
- no pregnancy,
- no systemic steroids,
- no severe asthma/copd,
- no severe collagen vascular disorders,
- no neoplastic or uncontrolled seizure activity,
- no previous anaphylaxis, no significant cardiovsacular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol
Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature.
Read the detailed description
Patients will be assessed for efficacy of the immunotherapy protocol by completing Consented-IRB approved clinical, medication, quality of life survey questions comparing current status while on therapy in contrast to 12 months before the inception of therapy.
- Being tested
- allergen immunotherapy
- Keywords
- Allergic Rhinitis, Allergen Immunotherapy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allergen immunotherapyOther
Also called allergy shots
allergy shots
What is being measured
The primary outcome is the main question the study is designed to answer.
change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective).
Enrolled patients completed surveys pertinent to symptom scores, contrasting current status on immunotherapy compared (by recall) to a 12 month time point prior to initiation of therapy.
Measured: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.
Secondary outcomes (1)
Changes in medication plus symptom aggregate score.
Aggregate Medication and Symptom surveys were compared to determine changes from a 12 month time point prior to inception of therapy to current time point of 1 to 2 years of therapy.
Measured: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic Rhinitis With Seasonal VariationStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Allergy Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Frederick M. Schaffer, MD, United Allergy Services
- Investigators
- Frederick M Schaffer, M.D., Principal investigator, United Allergy Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699659
- Sponsor's protocol ID
- UAS protocol #1
- Other IDs
- UAS protocol #1
- Status last verified
- Oct 2012
- First submitted
- 10 Sep 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol
- ClinicalTrials.gov ID
- NCT01699659
- Acronym / sponsor ID
- UAS protocol #1
- Keywords
- Allergic Rhinitis, Allergen Immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- United Allergy ServicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Oct 2012 (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.
Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature.
Detailed description
Patients will be assessed for efficacy of the immunotherapy protocol by completing Consented-IRB approved clinical, medication, quality of life survey questions comparing current status while on therapy in contrast to 12 months before the inception of therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with allergic rhinitis pre and post immunotherapy (1 to 2 years).
Key inclusion criteria (1 listed)
- Allergic rhinitis between 18 and 65 years old who have chosen to undergo immunotherapy.
Key exclusion criteria (7 listed)
- No beta blocker use,
- no pregnancy,
- no systemic steroids,
- no severe asthma/copd,
- no severe collagen vascular disorders,
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 |
|---|---|---|
| allergen immunotherapyAlso: allergy shotsallergy shots | Other | – |
Primary outcome
change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective).
Time frame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.
Enrolled patients completed surveys pertinent to symptom scores, contrasting current status on immunotherapy compared (by recall) to a 12 month time point prior to initiation of therapy.
1 secondary outcome
Changes in medication plus symptom aggregate score.
Time frame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.
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 4 Oct 2012.
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.
Frederick M Schaffer, M.D. principal investigator
United Allergy Services
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 Perennial Allergic Rhinitis With Seasonal Variation, run by United Allergy Services 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 1 inclusion and 7 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 4 Oct 2012. 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.
What does the primary outcome measure?
change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective). (time frame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.). It is what the study was designed to measure, not a finding.
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 4 Oct 2012.