Study of AHIST in Seasonal Allergic Rhinitis Patients

• Status: Withdrawn
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

A) To gather pharmacodynamic measurements and assess blood levels of the active ingredients in AHIST over the dosage interval period of 12 hours.

Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic window data);

B) To report subjective scores by subjects rating the efficacy of a single dose AHIST in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a 12-hour dosage interval.

Hypothesis: Greater than 66% of subjects will document clinically significant relief over a 12-hour period from one dose of AHIST;

C) Report any side effects or adverse drug reactions and rate the severity of any incidence.

Hypothesis: Not more than one patient will have an adverse event significant enough to warrant withdrawal; side effects will be mild with the most frequently reported side effect occurring in less than 10% of patients-drowsiness.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Magna Pharmaceuticals, Inc.
• Treatments: Chlorpheniramine

Criteria

Inclusion Criteria:

1. Male and females of any ethnic group between 18 and 60 years of age.

2. History of moderate to severe Seasonal Allergic Rhinitis (SAR) for at least two years.

3. Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms ("S5") that are the focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal drip.

4. Prior to study drug administration, subjects' good health will be confirmed by medical history, physical examination, and urine dip pregnancy test.

5. Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established patient medical history.

Exclusion Criteria:

1. Pregnancy or lactation.

2. Immunotherapy unless at stable maintenance dose.

3. Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems.

4. Alcohol dependence.

5. Use of any other investigational drug in the previous month.

6. Subjects presenting with asthma requiring corticosteroid treatment.

7. Subjects with multiple drug allergies.

8. Subjects known to have an idiosyncratic reaction to any of the ingredients in AHIST.