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NCT02245360 Clinical Trial

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
Secondary ID
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

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
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