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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Russian Federation,
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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