The Impact of Grass SLIT Treatment on Birch Pollen Induced Allergic Rhinitis - a Pilot Evaluation

NCT ID: NCT02394600

Last Updated: 2018-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-06-30

Brief Summary

This pilot study is a Phase IV, single center, placebo-controlled, parallel study design conducted using the Environmental Exposure Unit (EEU). The study will aim to be determine whether there are any benefits from Grastek® for the treatment of birch-pollen induced allergic rhinoconjunctivitis. Grastek® is a Health Canada and FDA approved sublingual immunotherapy (SLIT) for the treatment of grass-pollen induced allergic rhinoconjunctivitis. The EEU provides a closed environment in which participants are exposed to a predetermined, controlled, constant level of airborne pollen. 96 participants will complete this study and will either receive Grastek® or placebo in a 1:1 ratio. The study will consist of a screening visit, a pre-treatment pollen exposure visit, 60 days of treatment with Grastek® or placebo, two treatment visits and a follow-up pollen exposure visit.

Conditions

Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Grastek®

48 participants will receive Grastek® once per day for 120 days. Grastek® is a standardized sublingual immunotherapy (SLIT) tablet containing 2800 BAU of standardized allergen extract from Timothy grass (Phleum pretense). This SLIT product is approved by Health Canada and the Food and Drug Administration (FDA) for the treatment of grass-pollen induced allergic rhinoconjunctivitis (AR) in Canada and the United States respectively.

Group Type: EXPERIMENTAL

Grastek®

Intervention Type: DRUG

one tablet daily for four months

Placebo

48 participants will receive placebo once per day for 120 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one tablet daily for four months

Interventions

Grastek®

one tablet daily for four months

Intervention Type: DRUG

Placebo

one tablet daily for four months

Intervention Type: DRUG

Other Intervention Names

sugar pill

Eligibility Criteria

Inclusion Criteria

1. Participant demonstrates understanding and has provided an appropriately signed and dated informed consent.

2. Male or Female, 18 to 65 years of age, at time of the Screening visit.

3. Participant has a history of at least moderate allergic rhinoconjunctivitis due to hypersensitivity to birch pollen for a minimum of 2 years.

4. Participant responds to the birch pollen and timothy grass pollen through a standard skin prick test administered at the Screening visit. A positive test will be defined as a wheal diameter at least 5mm or larger than the negative control (normal saline) wheal. A historical skin-prick test performed within three-hundred sixty-five (365) days or one (1) year at the site will be accepted in lieu of performing a new skin prick test.

5. Participant understands and is willing, able and likely to comply with study procedures and restrictions.

6. Participant, if female, has a negative urine pregnancy test at Visit 1 and is willing to use a medically acceptable form of birth control. Acceptable methods of birth control for this study include:

• oral, patch, or intra-vaginal hormonal contraceptives
• Norplant System®
• Depo-Provera®
• IUD
• double barrier method
• abstinence
• surgically sterile females (hysterectomy or tubal ligation)
• > 1 year post-menopausal females
• same sex partner
• partner vasectomy (> 3 months)

7. Participant is healthy as determined by pre-study medical history, physical examination and vital signs.

8. Participant is able to read, comprehend, and record all information in English.

9. Participant has a serum specific IgE level to both birch and timothy grass of ≥0.7 ku/L.

Exclusion Criteria

1. Has significant current nasal or ocular symptoms that the study doctor associates with perennial allergic or non-allergic rhinitis.

2. Female participant who is pregnant or lactating.

4. Has any significant abnormalities found during physical exam as determined by the investigator.

5. Has a current medical history of significant pulmonary disease and/or active asthma requiring daily drug therapy. Mild, intermittent asthma is permitted (managed with short acting beta-agonist less than 3 times per week). Isolated exercise-induced bronchospasm is also permitted.

6. Has received an investigational drug within the last thirty (30) days.

7. Has had use of immunotherapy containing grass or birch within the last 3 years.

8. Has significant nasal polyps, nasal septal perforation, or nasal tract malformations as noted on physical exam.

9. Administration of adrenaline (epinephrine) is contraindicated (e.g. participants with acute or chronic symptomatic coronary heart disease or concomitant beta-blocker therapy).

10. Is unlikely to cooperate with the requirements of the study including having the ability to communicate with the investigator appropriately.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anne Ellis

Chair, Division of Allergy & Immunology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne K Ellis, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Kingston General Hospital

Kingston, Ontario, Canada

Countries

Canada

References

Ellis AK, Tenn MW, Steacy LM, Adams DE, Day AG, Walker TJ, Nolte H. Lack of effect of Timothy grass pollen sublingual immunotherapy tablet on birch pollen-induced allergic rhinoconjunctivitis in an environmental exposure unit. Ann Allergy Asthma Immunol. 2018 May;120(5):495-503.e2. doi: 10.1016/j.anai.2018.02.003. Epub 2018 Feb 9.

Reference Type: DERIVED

PMID: 29432967 (View on PubMed)

Other Identifiers

EEU-MERCK 001

Identifier Type: -

Identifier Source: org_study_id