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Study of AHIST in Seasonal Allergic Rhinitis Patients

This study has suspended participant recruitment.
(Manufacturer unable to produce)
Sponsor:
Information provided by:
Magna Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01008397
First received: October 27, 2009
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
 Drug: AHIST NDC#58407-012-01
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by Magna Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To report any side effects or adverse drug reactions and rate the severity of incidence. [ Time Frame: April 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 21
Study Start Date: April 2011
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AHIST for seasonal allergic rhinitis
AHIST for SAR: each green tablet contains 12mg chlorpheniramine tannate.
 Drug: AHIST NDC#58407-012-01
Oral tablet containing chlorpheniramine tannate 12mg.
Other Name: AHIST NDC#58407-012-01

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008397

Locations
United States, Kentucky
Family Allergy and Asthma Research Institute
Louisville, Kentucky, United States, 40215
Sponsors and Collaborators
Magna Pharmaceuticals, Inc.
Investigators
Principal Investigator: Stephen J Pollard, MD Family Allergy and Asthma Research Institute
  More Information

No publications provided

Responsible Party: Warren P. Lesser/President, MAGNA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01008397     History of Changes
Other Study ID Numbers: AHIST IND
Study First Received: October 27, 2009
Last Updated: February 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Magna Pharmaceuticals, Inc.:
Rhinitis, Allergic, Seasonal

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Chlorpheniramine
 Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013