Mechanistic study assessing the immunological response of subjects after treatment with different formulations of sublingual immunotherapy. - Assessing the immunological response after sublingual immunotherapy

Phase 1

• Conditions: Patients with seasonal allergic rhinitis to grass pollen; MedDRA version: 14.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2006-002123-17-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-01-01
• Study Start: 2012-01-23
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Male and female 18-65 years of age
Written informed consent obtained before entering the trial
A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
A clinical history of severe rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep), which remain troublesome despite treatment with anti-allergic drugs during the grass pollen season
Positive Skin Prick Test (SPT) response (wheal diameter = 3 mm) to Phleum pratense
Positive specific IgE against Phleum pratense (= IgE Class 2)
Physical examination with no clinically relevant findings
If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the trial
Willingness to comply with this protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of – and potentially overlapping - the grass pollen season
A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed
History of emergency visit or admission for asthma in the previous 12 months
Use of an investigational drug within 30 days prior to screening
Previous treatment by immunotherapy with grass pollen allergen within the previous 10 years
History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
History of angioedema
Any of the following underlying conditions known or suspected to be present:
Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alcoholism
Ischemic heart disease or angina requiring current daily medication
Or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease)
Immunosuppressive treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the immunological response in subjects with grass pollen induced allergic rhinoconjunctivitis after 8 weeks of once daily dosing with sublingual immunotherapy, either Alutard SQ Phleum pratense, 25,000 SQ-U, ALK Grass tablet Phleum pratense 25,000 SQ-T, or Aquagen Phleum pratense, 25,000 SQ-U. ;Secondary Objective: To evaluate the safety of the three different formulations by assessing adverse events recorded daily by the patient.<br><br>;Primary end point(s): To evaluate the immunological response in subjects with grass pollen induced allergic rhinoconjunctivitis after 8 weeks of once daily dosing with sublingual immunotherapy, either Alutard SQ Phleum pratense, 25,000 SQ-U, ALK Grass tablet Phleum pratense 25,000 SQ-T, or Aquagen Phleum pratense, 25,000 SQ-U.