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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245360
• Other study ID #: GRAS3001
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2014
• Last updated: December 9, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Phleum pratense grass pollen allergen extract
Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
• placebo
placebo tablet given once daily over 60 days

Locations

Country	Name	City	State
Russian Federation	Research facility ID ORG-001005	Moscow
Russian Federation	Research facility ID ORG-001006	Moscow
Russian Federation	Research facility ID ORG-001009	Moscow
Russian Federation	Research facility ID ORG-001014	Moscow
Russian Federation	Research facility ID ORG-001016	Moscow
Russian Federation	Research facility ID ORG-001018	Moscow
Russian Federation	Research facility ID ORG-001085	Moscow
Russian Federation	Research facility ID ORG-001086	Moscow
Russian Federation	Research facility ID ORG-001015	Samara
Russian Federation	Research facility ID ORG-001021	Saratov
Russian Federation	Research facility ID ORG-001017	Smolensk
Russian Federation	Research facility ID ORG-001007	St. Petersburg
Russian Federation	Research facility ID ORG-001008	St. Petersburg
Russian Federation	Research facility ID ORG-001019	St. Petersburg
Russian Federation	Research facility ID ORG-001020	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum	measurement of IgG4 in serum	baseline versus end of treatment (approx. 60 days)	No
Secondary	Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment	measurement of IgE in serum	baseline versus end of treatment (approx. 60 days)	No