Status:
COMPLETED
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Lead Sponsor:
Abbott
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 al...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT02245360
Start Date
October 1 2014
End Date
March 1 2015
Last Update
January 11 2016
Active Locations (15)
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1
Research facility ID ORG-001086
Moscow, Russia, 105077
2
Research facility ID ORG-001018
Moscow, Russia, 115446
3
Research facility ID ORG-001005
Moscow, Russia, 115478
4
Research facility ID ORG-001009
Moscow, Russia, 119333