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Can Epinephrine Coated Syringe for Subcutaneous Immunotherapy (SCIT) Reduce Large Local Reaction?

NCT03963115 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-02-20

No results posted yet for this study

Summary

Allergen immunotherapy is effective in the management of allergic asthma, allergic rhinitis/conjunctivitis, and stinging insect hypersensitivity. The most common side effect of subcutaneous allergen specific immunotherapy (SCIT) is local reactions (LR). Although some studies indicated that LR did not predict systemic reaction (SR), patients with higher frequency of large local reaction (LLR) were reported to have higher risk for SR. Epinephrine may decrease LLR due to its vasoconstrictive effect . The objective of this study was to compare the size of LLR in patients receiving SCIT with epinephrine or normal saline coated syringe. The patients who complained of frequent LLR despite pre-medication and local treatment were recruited.

Conditions

  • Injection Reactions Site
  • Systemic Reactions

Interventions

DRUG

Epinephrine or normal saline

epinephreine or normal saline coated syringe before drawing allergen for injection.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Orathai Piboonpocanun, MD · Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2019-08-25
Completion
2019-09-01

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963115 on ClinicalTrials.gov