Clinical Trial: Study of AHIST in Seasonal Allergic Rhinitis Patients
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients
Brief 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.
Detailed Summary:
This Phase 1 clinical trial will be a single dose pharmacokinetics study comprised of 21 individuals with five blood draws over a 12 hour period. Additionally, subjects will subjectively score symptom relief and report any side effects from the single dose of AHIST. Schulman Associates Institutional Review Board (Cincinnati, OH) will approve the study protocol and statement of informed consent. Each study participant will give written informed consent (See Attachment A). Safety will be assured through close observation and physical examination of subjects before, during and at study conclusion. This interventional study will be conducted during the spring allergy season of 2010.
MAGNA plans to show that chlorpheniramine tannate is a safe and effective B.I.D. drug treatment regimen, "indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]."
Sponsor: Magna Pharmaceuticals, Inc.
Current Primary Outcome: To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours. [ Time Frame: April 2011 ]
Original Primary Outcome: To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours. [ Time Frame: April 2010 ]
Current Secondary Outcome: To report any side effects or adverse drug reactions and rate the severity of incidence. [ Time Frame: April 2011 ]
Original Secondary Outcome: To report any side effects or adverse drug reactions and rate the severity of incidence. [ Time Frame: April 2010 ]
Information By: Magna Pharmaceuticals, Inc.
Dates:
Date Received: October 27, 2009
Date Started: April 2011
Date Completion: May 2011
Last Updated: March 4, 2014
Last Verified: February 2011
