Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis

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

Sponsors

Lead Sponsor: Abbott

Source Abbott
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.

Overall Status Completed
Start Date October 2014
Completion Date March 2015
Primary Completion Date March 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum baseline versus end of treatment (approx. 60 days)
Secondary Outcome
Measure Time Frame
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment baseline versus end of treatment (approx. 60 days)
Enrollment 107
Condition
Intervention

Intervention Type: Drug

Intervention Name: Phleum pratense grass pollen allergen extract

Description: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days

Arm Group Label: Grass tablet 75,000 SQ-T

Other Name: GRAZAX/GRASTEK

Intervention Type: Drug

Intervention Name: placebo

Description: placebo tablet given once daily over 60 days

Arm Group Label: Placebo

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dmitri Kazei, MD PhD Study Director Abbott
Location
Facility:
Research facility ID ORG-001086 | Moscow, 105077, Russian Federation
Research facility ID ORG-001018 | Moscow, 115446, Russian Federation
Research facility ID ORG-001005 | Moscow, 115478, Russian Federation
Research facility ID ORG-001009 | Moscow, 119333, Russian Federation
Research facility ID ORG-001016 | Moscow, 119991, Russian Federation
Research facility ID ORG-001006 | Moscow, 123182, Russian Federation
Research facility ID ORG-001085 | Moscow, 123182, Russian Federation
Research facility ID ORG-001014 | Moscow, 142190, Russian Federation
Research facility ID ORG-001015 | Samara, 443099, Russian Federation
Research facility ID ORG-001021 | Saratov, 410028, Russian Federation
Research facility ID ORG-001017 | Smolensk, 214019, Russian Federation
Research facility ID ORG-001007 | St. Petersburg, 193231, Russian Federation
Research facility ID ORG-001019 | St. Petersburg, 195030, Russian Federation
Research facility ID ORG-001008 | St. Petersburg, 198216, Russian Federation
Research facility ID ORG-001020 | Ufa, 450000, Russian Federation
Location Countries

Russian Federation

Verification Date

December 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Grass tablet 75,000 SQ-T

Type: Experimental

Description: Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)

Label: Placebo

Type: Placebo Comparator

Description: Placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov