Exploratory Study for Allergy Relief Onset

Bayer

Status and phase

Terminated

Phase 2

Conditions

Rhinitis, Allergic

Treatments

Drug: Placebo

Drug: Chlorpheniramine maleate (BAY X002134)

Study type

Interventional

Funder types

Industry

Identifiers

18573

Details and patient eligibility

About

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

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.