Exploratory Study for Allergy Relief Onset

NCT02722083 | Terminated Phase 2

• 1 other identifier: 18573
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

• The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS)

  4 hours

Secondary Outcomes (1)

• Number of patients with adverse events as a measure of safety

  3 month

Study Arms (2)

BAY X002134

EXPERIMENTAL

Subjects will be given BAY X002134

Drug: Chlorpheniramine maleate (BAY X002134)

Placebo

PLACEBO COMPARATOR

Subjects will be given a placebo

Drug: Placebo

Interventions

Chlorpheniramine maleate (BAY X002134) DRUG

4 mg tablet, single dose, orally

BAY X002134

Placebo DRUG

placebo tablet, single dose, orally

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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Chlorpheniramine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 29, 2016
• Study Start: May 7, 2016
• Primary Completion: May 27, 2016
• Study Completion: July 13, 2016
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)