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Efficacy of Sublingual Immunotherapy in Polysensitized Allergic Rhinitis Patients

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01247259
First received: November 18, 2010
Last updated: November 22, 2010
Last verified: November 2010
History of Changes

November 18, 2010
November 22, 2010
November 2007
February 2010   (final data collection date for primary outcome measure)
total nasal symptom score (TNSS) and anti-allergic medication score (AMS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01247259 on ClinicalTrials.gov Archive Site
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Efficacy of Sublingual Immunotherapy in Polysensitized Allergic Rhinitis Patients
Efficacy of Sublingual Immunotherapy With House Dust Mite Extract in Poly-allergen-sensitized Allergic Rhinitis Patients

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.
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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Allergic Rhinitis
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-mono
    Intervention: Drug: Pangramin®
  • Active Comparator: SLIT-poly
    Intervention: Drug: Pangramin®
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
October 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
4 Years to 53 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01247259
SLIT-POLYSENSITIZATION
No
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Seoul National University Hospital
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Principal Investigator: Dong-Young Kim, MD, PhD Seoul National University Hospital
Seoul National University Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP