Safety of Lymph Node Injection for Allergen Immunotherapy
Status unconfirmed · Phase 1 · Has a placebo group
Conditions studied: Allergic Rhinitis
In brief
The purpose of this study is to determine safety of allergy immunotherapy lymph node injections for grass pollen allergies.
Key facts
- Study ID
- NCT01982474
- Run by
- Amber Patterson
- People needed
- 18
- Starts
- 2013-10-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2016-02-09
Who can join
Age: 15 and older, up to 24. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 15-24 years
- Bothersome nasal, ocular, and/or respiratory symptoms correlating with grass pollen season (summer)
- Grass pollen allergic (+ skin prick test [wheal ≥ 3 mm larger than negative control] or specific IgE [minimum 0.35 kU/L] to grass pollen [Timothy or a northern pasture grass mix containing Timothy])
- Informed consent obtained and signed
- Informed assent (as appropriate) obtained and signed
- Understanding of study procedures
- Ability to comply with study procedures for the entire length of the study
- For inclusion in observational group (arm 3), must have initiated SCIT containing grass pollen 12 - 18 months prior to grass pollen season 2014 (ex. started SCIT any time Dec 2012 - May 2013). This group was included for comparison between traditional IT and ILIT, and these subjects will continue SCIT during this study. Since patients undergoing SCIT may not see clinical response to therapy until 12 months, we selected this time point to better compare with the more rapid immunologic and clinical changes expected with ILIT.
You may not qualify if…
- Significant year-round allergy symptoms and year-round symptoms without worsening during grass pollen season (summer). (Exception: intermittent year-round symptoms with significant worsening during summer is acceptable for inclusion).
- Blood donation or surgery within the previous 30 days of baseline/enrollment, visit #1.
- Use of investigational drugs within the previous 90 days
- Pregnancy or nursing
- Mastocytosis
- Significant cardiovascular, hepatic, renal, autoimmune, hematological, or active infectious disease
- History of malignancy, hypertension, use of immunosuppressive agents, beta-blockers, ACE inhibitors, or tricyclic antidepressants
- Pulmonary disease, including moderate to severe, perennial asthma (FEV1 < 80% predicted) and perennial use of inhaled corticosteroids (exception: seasonal allergic asthma will not be excluded)
- Previous IT (exception: those in observational arm currently on grass SCIT).
- No readily accessible inguinal lymph nodes
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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