Clinical Trials Logo

Clinical Trial Summary

This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept study which will evaluate the effect of a preparation of FDA approved allergens (PMA) used as a sub-cutaneously administered immunotherapy for the management of allergic rhinitis (perennial and seasonal).


Clinical Trial Description

This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept study which will evaluate the effect of a proprietory mixed preparation of FDA approved allergens (PMA) used as a sub-cutaneously administered immunotherapy for the management of allergic rhinitis (perennial and seasonal). Participating study subjects will be required to manifest the signs and symptoms of allergic rhinitis and test positive to at least six allergens using a multi aeroallergen screen at the time of study recruitment . All subjects will undergo standard allergen skin prick testing using six Multi-Test® PC skin prick test devices (Lincoln Diagnostics, Decator, IL) or comparable skin testing technique for a total of 48 Skin Prick Test (SPT). Approximately 36 total subjects will be enrolled.

Following a successful screening study visit and two week medication washout period, a 8 week treatment period will be initiated with bi-weekly study visits being undertaken, through to the end of immunotherapy, for assessment of therapeutic response and safety evaluations. Efficacy evaluation will be monitored using validated instruments that assess study subject clinical response, physician global assessment, and medication use. A safety assessment will be undertaken one month following completion of treatment.

At the screening visit (Screening Visit) a potential study subject will be required to fulfill the requirements of the study inclusion and exclusion criteria, will have a clinical evaluation including medical history and physical examination, blood draw and performance of skin testing. The study subject will then abstain from using intranasal steroids and antihistamines for two weeks and then return to the clinic for administration of sub-cutaneous PMA and post-treatment in-clinic safety evaluation. The latter evaluation period will comprise approximately 60 minutes to assess the study subject's response to PMA immunotherapy. Follow up clinic study visits will continue bi-weekly through 8 weeks and at each of these visits the study subject will receive increasing doses of PMA immunotherapy and will be evaluated for safety. Twice weekly clinical evaluation will also be performed. Following the final administration of PMA immunotherapy, a one month follow-up safety and clinical efficacy evaluation will be conducted by telephone or in the clinic. The duration of the study will be approximately 14 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03360071
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 2
Start date December 19, 2016
Completion date November 1, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT05080322 - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis Phase 4
Recruiting NCT06028490 - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis. Phase 2
Completed NCT04388358 - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation N/A
Recruiting NCT04202263 - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline Phase 2
Completed NCT04078009 - Standardising Nasal Allergen Challenge in Adult With Hay Fever N/A
Completed NCT03644680 - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study N/A
Completed NCT04541004 - Adolescent Mite Allergy Safety Evaluation Phase 3
Recruiting NCT05378594 - HDM and Silver Birch NAC Standardisation N/A
Not yet recruiting NCT05684380 - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER) Phase 3
Completed NCT02910401 - Clinical Response to Rhinovirus Challenge Phase 2
Completed NCT02943720 - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen Phase 2
Not yet recruiting NCT01014325 - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy Phase 3
Completed NCT02556801 - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy Phase 2
Completed NCT02352168 - Airway Inflammation in Children With Allergic Rhinitis and Intervention N/A
Not yet recruiting NCT02233426 - Effect of Hypertonic Solutions on Allergic Rhinitis Patients N/A
Completed NCT01918956 - PURETHAL Birch RUSH Study Phase 4
Completed NCT01946035 - Alpha-Blockers in Allergic Rhinitis (MAN 01) Phase 4
Completed NCT01682070 - SUBLIVAC FIX Phleum Pratense DT/DRF Phase 2
Recruiting NCT01454492 - The Relationship Between Allergic Rhinitis and Geographic Tongue N/A
Completed NCT01439815 - An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo Phase 4