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Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis

Efficacy and Safety of Single Doses of Norketotifen in Adult Subjects With Allergen-Induced Allergic Rhinitis in an Allergen Challenge Chamber

NCT03887026•Emergo Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 2a study to evaluate the efficacy and safety of Norketotifen (NKT) in subjects with allergic rhinitis.

Detailed Description

This is a single-center, double-blind, randomized, placebo-controlled, 3-way crossover study evaluating the efficacy and safety of NKT in adult subjects with allergen-induced allergic rhinitis in an allergen challenge chamber.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability and willingness to provide informed consent and comply with the protocol procedures
•Males and females, age 18 to 45 years, inclusive
•Other than seasonal allergic rhinitis, participant is healthy as determined by pre-study medical history, physical examination and vital signs. Any chronic conditions that may interfere with the study outcomes or the subject's safety will be considered clinically significant and a reason for exclusion.
•History of seasonal allergic rhinitis to mountain cedar pollen for at least the past 2 consecutive seasons
•Positive mountain cedar pollen skin prick test at Screening or within 12 months prior to Screening (wheal diameter ≥5 mm larger than the negative control)
•For females, negative serum pregnancy test. Females of childbearing potential and males must agree to use required contraception as outlined in the protocol

Exclusion Criteria

•Female subjects who are pregnant or lactating
•Any history of epilepsy, diabetes mellitus, blood pressure abnormalities or cardiac arrhythmias
•Presence of any uncontrolled medical or psychiatric illness
•Treatment for controlled concurrent medical conditions has not been stable in terms of either doses or medications for at least 30 days prior to the baseline visit or is anticipated to change during the study
•Current use of or expected use of any of the prohibited medications within the indicated withholding timeframes as outlined in the protocol
•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 subject by their participation in the study
•Any history of malignancy within the past 5 years, with the exception of non-melanoma skin cancer
•History of 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
•Any infection or inflammatory condition within the 2 weeks prior to screening
•Positive human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) antibody screen
+7 more criteria

Locations (1)

Biogenics Research Chamber

San Antonio, Texas, United States

Key Dates

Start Date

April 1, 2019

Primary Completion Date

May 18, 2019

Completion Date

May 29, 2019

Last Updated

August 21, 2020

Enrollment

ACTUAL participants

Conditions

Allergic RhinitisAllergic Rhinoconjunctivitis

Interventions

Norketotifen

DRUG

Placebo

DRUG

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

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Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a

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RECRUITINGNA

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

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Acute RhinitisNasal Obstruction+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis

Inclusion Criteria

Exclusion Criteria

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

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