Exploratory Study for Allergy Relief Onset

A Single-blind, Randomized, Placebo Controlled, Crossover Pilot Study to Evaluate the Onset of Action of an Antihistamine in Subjects Following Allergen Exposure in an Allergen Chamber

The purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment.

Study Overview

• Status: Terminated
• Conditions: Rhinitis, Allergic
• Intervention / Treatment: Drug: Chlorpheniramine maleate (BAY X002134); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Germantown, Tennessee, United States, 38138

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ambulatory healthy male and female subjects between 18 to 65 years of age inclusive;
• Self-reported to have seasonal allergic rhinitis for at least 2 years prior
• Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal > 4mm larger than the diluent within the previous 12 months
• Total Symptom Score (TSS) ≥ 40 mm at the 90 or 120 minute time point during one of the Priming Visits and at 90 or 120 minute time points during ragweed challenge Symptom Induction Phase of each Treatment Visit;
• Body Mass Index (BMI) in the range of 18 to 30 kg/m2
• Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera®), or a double barrier and have a negative pregnancy test at Screening and prior to IMP administration on Day 1 and Day 7 ± 1 day. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy

Exclusion Criteria:

• Evidence or self-reported history of significant medical condition which, in the judgment of the investigator, is a contraindication to the use of chlorpheniramine, or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease , symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, narrow-angle glaucoma, pyloroduodenal obstruction, or stenosing peptic ulcer;
• Known allergy to chlorpheniramine, dexchlorpheniramine, or any of its inactive ingredients
• Self-reported non-responders (lack of therapeutic effect) to antihistamines
• Administration of epinephrine is contra-indicated;
• Current use of oral steroids, including prednisone and prednisolone;
• Females who are pregnant or lactating
• A history of anaphylaxis to ragweed allergen
• Subjects with a history of asthma, lower respiratory tract disease, emphysema or chronic bronchitis; At the discretion of the investigator, subjects with self-reported mild intermittent asthma or exercise induced asthma may be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BAY X002134; Subjects will be given BAY X002134	Drug: Chlorpheniramine maleate (BAY X002134); 4 mg tablet, single dose, orally
PLACEBO_COMPARATOR: Placebo; Subjects will be given a placebo	Drug: Placebo; placebo tablet, single dose, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS)	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events as a measure of safety	3 month

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2016
• Primary Completion (ACTUAL): May 27, 2016
• Study Completion (ACTUAL): July 13, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (ESTIMATE): March 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Chlorpheniramine
• Other Study ID Numbers: 18573

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No