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Efficacy and safety of D. pteronyssinus immunotherapy in local allergic rhinitis: a double‐blind placebo‐controlled clinical trial
Author(s) -
Rondón C.,
Campo P.,
Salas M.,
Aranda A.,
Molina A.,
González M.,
Galindo L.,
Mayorga C.,
Torres M. J.,
Blanca M.
Publication year - 2016
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/all.12889
Subject(s) - medicine , placebo , provocation test , clinical endpoint , adverse effect , allergen , allergy , randomized controlled trial , nasal provocation test , clinical trial , immunology , gastroenterology , pathology , alternative medicine
The effects of allergen immunotherapy ( AIT ) on local allergic rhinitis ( LAR ) are largely unknown. We conducted the first randomized, double‐blind, placebo‐controlled ( DBPC ), phase II trial of D. pteronyssinus ( DP ) subcutaneous AIT ( DP ‐ AIT ) on LAR (clinicaltrials.gov identifier: NCT 02123316). Thirty‐six LAR patients received Pangramin PLUS DP or placebo for 24 months. The primary endpoints were symptoms, medication scores, and medication‐free days. The secondary included skin test, serum specific IgE and IgG4, nasal allergen provocation test ( NAPT ), and adverse events. AIT ‐ DP produced significant improvements in both primary and secondary endpoints vs placebo. After 12 months of AIT ‐ DP , we detected a significant and marked increase in allergen tolerance with negative NAPT in 50% of patients, and significant increases of serum sIgG 4. Immunotherapy was well tolerated; no systemic reactions were reported. This study demonstrated that AIT ‐ DP is a safe and clinically effective treatment for LAR , confirming that LAR is a new indication for AIT.