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

NCT02394600 | Completed Phase 4 Results

• 1 other identifier: EEU-MERCK 001
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Keywords

rhinitis; allergy

Outcome Measures

Primary Outcomes (1)

• Change in Total Nasal Symptom Score (TNSS) From Baseline to Post-treatment.

  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.

  4 months

Secondary Outcomes (1)

• Analysis of Blood Samples for Potential Biomarkers by Comparing Baseline and Post-treatment Samples.

  4 months

Study Arms (2)

Grastek®

EXPERIMENTAL

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®

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Grastek® DRUG

one tablet daily for four months

Grastek®

Placebo DRUG

one tablet daily for four months

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant demonstrates understanding and has provided an appropriately signed and dated informed consent.
• Male or Female, 18 to 65 years of age, at time of the Screening visit.
• Participant has a history of at least moderate allergic rhinoconjunctivitis due to hypersensitivity to birch pollen for a minimum of 2 years.
• 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.
• Participant understands and is willing, able and likely to comply with study procedures and restrictions.
• 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

You may not qualify if:

• Has significant current nasal or ocular symptoms that the study doctor associates with perennial allergic or non-allergic rhinitis.
• Female participant who is pregnant or lactating.
• Has any significant abnormalities found during physical exam as determined by the investigator.
• 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.
• Has received an investigational drug within the last thirty (30) days.
• Has had use of immunotherapy containing grass or birch within the last 3 years.
• Has significant nasal polyps, nasal septal perforation, or nasal tract malformations as noted on physical exam.
• Administration of adrenaline (epinephrine) is contraindicated (e.g. participants with acute or chronic symptomatic coronary heart disease or concomitant beta-blocker therapy).
• Is unlikely to cooperate with the requirements of the study including having the ability to communicate with the investigator appropriately.

Sponsors & Collaborators

• Queen's University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• 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.

  PMID: 29432967 DERIVED

MeSH Terms

Conditions

Rhinitis; Hypersensitivity

Interventions

Sugars

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Anne Ellis
• Organization: Kingston General Hospital

ellisa@kgh.kari.net

613-548-2336

Study Officials

• Anne K Ellis, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Division of Allergy & Immunology

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 20, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 29, 2018
• Results First Posted: January 29, 2018

Record last verified: 2017-06

Locations

CA (1)