Study of AHIST in Seasonal Allergic Rhinitis Patients
Information source: Magna Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Seasonal
Intervention: AHIST NDC#58407-012-01 (Drug)
Phase: Phase 1
Status: Withdrawn
Sponsored by: Magna Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Stephen J Pollard, MD, Principal Investigator, Affiliation: Family Allergy and Asthma Research Institute
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.
Clinical Details
Official title: Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Secondary outcome: To report any side effects or adverse drug reactions and rate the severity of incidence.
Detailed description:
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]."
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Family Allergy and Asthma Research Institute, Louisville, Kentucky 40215, United States
Additional Information
Starting date: April 2011
Last updated: March 4, 2014
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