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Efficacy of Sublingual Immunotherapy in Polysensitized Allergic Rhinitis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247259
First Posted: November 24, 2010
Last Update Posted: November 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
  Purpose

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.


Condition Intervention
Allergic Rhinitis Drug: Pangramin®

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Sublingual Immunotherapy With House Dust Mite Extract in Poly-allergen-sensitized Allergic Rhinitis Patients

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • total nasal symptom score (TNSS) and anti-allergic medication score (AMS) [ Time Frame: 1 year ]

Enrollment: 134
Study Start Date: November 2007
Study Completion Date: October 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SLIT-mono Drug: Pangramin®
During a 4-week increasing-dose phase, the patients increased the daily dose from 1 to 5 drops of 1.6 STU/mL solution from day 1 to 10, 1 to 5 drops of 8 STU/mL solution from day 11 to 15, 1 to 5 drops of 40 STU/mL solution from day 16 to 20, 1 to 5 drops of 200 STU/mL solution from day 21 to 25, and 1 to 5 drops of 1000 STU/mL solution from day 26 to 30. After reaching the maintenance dose, 5 drops of 1000 STU/mL solution, the patients took the allergen three times per week during the maintenance phase.
Active Comparator: SLIT-poly Drug: Pangramin®
During a 4-week increasing-dose phase, the patients increased the daily dose from 1 to 5 drops of 1.6 STU/mL solution from day 1 to 10, 1 to 5 drops of 8 STU/mL solution from day 11 to 15, 1 to 5 drops of 40 STU/mL solution from day 16 to 20, 1 to 5 drops of 200 STU/mL solution from day 21 to 25, and 1 to 5 drops of 1000 STU/mL solution from day 26 to 30. After reaching the maintenance dose, 5 drops of 1000 STU/mL solution, the patients took the allergen three times per week during the maintenance phase.

  Eligibility

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Ages Eligible for Study:   4 Years to 53 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247259


Locations
Korea, Republic of
Department of Otorhinolaryngology, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Dong-Young Kim, MD, PhD Seoul National University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01247259     History of Changes
Other Study ID Numbers: SLIT-POLYSENSITIZATION
First Submitted: November 18, 2010
First Posted: November 24, 2010
Last Update Posted: November 24, 2010
Last Verified: November 2010

Keywords provided by Seoul National University Hospital:
allergic rhinitis
immunotherapy
sublingual

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases