Clinical trial NCT02245360: Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Official title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the SQ Grass SLIT-tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: GRAZAX
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.


Eligibility criteria: Inclusion Criteria:

* clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.
* Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.
* Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.
* If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent
* Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))

Exclusion Criteria:

* Reduced lung function (defined as FEV1 \< 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
* Clinical history of uncontrolled asthma within 3 months prior to the screening visit

Primary outcomes:
measure: The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
timeFrame: baseline versus end of treatment (approx. 60 days)
Secondary outcomes:
measure: Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
timeFrame: baseline versus end of treatment (approx. 60 days)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001086
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001018
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001005
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001009
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001016
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001006
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001085
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001014
city: Samara
country: Russian Federation
facility: Research facility ID ORG-001015
city: Saratov
country: Russian Federation
facility: Research facility ID ORG-001021
city: Smolensk
country: Russian Federation
facility: Research facility ID ORG-001017
city: St. Petersburg
country: Russian Federation
facility: Research facility ID ORG-001007
city: St. Petersburg
country: Russian Federation
facility: Research facility ID ORG-001019
city: St. Petersburg
country: Russian Federation
facility: Research facility ID ORG-001008
city: Ufa
country: Russian Federation
facility: Research facility ID ORG-001020
Study officials:
affiliation: Abbott
name: Dmitri Kazei, MD PhD
role: STUDY_DIRECTOR
References: