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Efficacy of Sublingual Immunotherapy in Polysensitized Allergic Rhinitis Patients

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Seoul National University

Status

Completed

Conditions

Allergic Rhinitis

Treatments

Drug: Pangramin®

Study type

Interventional

Funder types

Other

Identifiers

NCT01247259
SLIT-POLYSENSITIZATION

Details and patient eligibility

About

Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic rhinitis. It is often suggested that polysensitized patients might not benefit from specific immunotherapy as much as monosensitized patients, although further research on this subject is needed. This study compared the efficacy of SLIT with standardized house dust mite extract in mono- and polysensitized allergic rhinitis patients.

Patients who were sensitized to house dust mites and treated with SLIT for house dust mites for at least 1 year between November 2007 and March 2010 were included. The mono-allergen sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was defined as the patients who were simultaneously sensitized to house dust mites and other allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy. Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea, sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.

This study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups, while the change in the TNSS did not differ significantly between the groups. The anti-allergic medication scores also decreased significantly in both groups, but there was no significant difference between the groups.

In polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in both nasal symptoms and rescue medication scores to those in monosensitized patients, regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized allergic rhinitis patients.

Enrollment

134 patients

Sex

All

Ages

4 to 53 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who had sneezing, itching, rhinorrhea, and nasal congestion with or without eye symptoms
  • patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df), as confirmed by skin prick testing (A/H ratio ≥ 1) or MAST

Exclusion criteria

  • Patients who had immunotherapy in the preceding 3 years
  • Patients who had systemic immunological disorders

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

134 participants in 2 patient groups

SLIT-mono
Active Comparator group
Treatment:
Drug: Pangramin®
SLIT-poly
Active Comparator group
Treatment:
Drug: Pangramin®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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