Study of AHIST in Seasonal Allergic Rhinitis Patients

Withdrawn before enrolling · Phase 1

Conditions studied: Rhinitis, Allergic, Seasonal

In brief

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.

Key facts

Study ID

NCT01008397

Run by

Magna Pharmaceuticals, Inc.

People needed

0

Starts

2011-04-01

Expected to finish

2011-05-01

Last updated by the study team

2014-03-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and females of any ethnic group between 18 and 60 years of age.
• History of moderate to severe Seasonal Allergic Rhinitis (SAR) for at least two years.
• 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.
• Prior to study drug administration, subjects' good health will be confirmed by medical history, physical examination, and urine dip pregnancy test.
• Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established patient medical history.

You may not qualify if…

• Pregnancy or lactation.
• Immunotherapy unless at stable maintenance dose.
• 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.
• Alcohol dependence.
• Use of any other investigational drug in the previous month.
• Subjects presenting with asthma requiring corticosteroid treatment.
• Subjects with multiple drug allergies.
• Subjects known to have an idiosyncratic reaction to any of the ingredients in AHIST.

Where it is running

• Family Allergy and Asthma Research Institute — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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