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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02394600
Recruitment Status : Completed
First Posted : March 20, 2015
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. Anne Ellis, Queen's University

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Drug: Grastek® Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Grass SLIT Treatment on Birch Pollen Induced Allergic Rhinitis - a Pilot Evaluation
Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: 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.
Drug: Grastek®
one tablet daily for four months

Placebo Comparator: Placebo
48 participants will receive placebo once per day for 120 days.
Drug: Placebo
one tablet daily for four months
Other Name: sugar pill




Primary Outcome Measures :
  1. Change in Total Nasal Symptom Score (TNSS) From Baseline to Post-treatment. [ Time Frame: 4 months ]

    To determine the effect of 4 months of treatment with Grastek® on the symptoms of birch pollen induced AR in participants with both timothy grass pollen-induced and birch pollen-induced allergen rhinitis (AR)

    TNSS is comprised of the sum of 4 symptoms: runny nose, itchy nose sneezing and nasal congestion. Each of these symptoms are evaluated based on a 4 point Likert scale from 0-3. 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. TNSS can therefore have a range from 0 to 12.



Secondary Outcome Measures :
  1. Analysis of Blood Samples for Potential Biomarkers by Comparing Baseline and Post-treatment Samples. [ Time Frame: 4 months ]
    To determine potential biomarkers predictive of clinical efficacy for birch pollen-induced AR following treatment with Grastek®



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  3. Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. This includes a clinically relevant medical or surgical history or presence of other respiratory disease (exceptions made for asthma and allergic rhinitis as defined in further exclusion criteria), or gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, immunological, dermatological, connective tissue diseases or disorders, or a history of malignancy within the past 5 years, with the exception of non-melanoma skin cancer.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394600


Locations
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Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Anne K Ellis, MD Queen's University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Anne Ellis, Chair, Division of Allergy & Immunology, Queen's University
ClinicalTrials.gov Identifier: NCT02394600    
Other Study ID Numbers: EEU-MERCK 001
First Posted: March 20, 2015    Key Record Dates
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018
Last Verified: June 2017
Keywords provided by Dr. Anne Ellis, Queen's University:
rhinitis
allergy
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases