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Study of AHIST in Seasonal Allergic Rhinitis Patients

Primary Purpose

Rhinitis, Allergic, Seasonal

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AHIST NDC#58407-012-01

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Rhinitis, Allergic, Seasonal

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Family Allergy and Asthma Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AHIST for seasonal allergic rhinitis

Arm Description

AHIST for SAR: each green tablet contains 12mg chlorpheniramine tannate.

Outcomes

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.

Secondary Outcome Measures

To report any side effects or adverse drug reactions and rate the severity of incidence.

Full Information

NCT ID

NCT01008397

First Posted

October 27, 2009

Last Updated

March 4, 2014

Sponsor

Magna Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01008397

Brief Title

Study of AHIST in Seasonal Allergic Rhinitis Patients

Official Title

Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Manufacturer unable to produce

Study Start Date

April 2011 (undefined)

Primary Completion Date

April 2011 (Anticipated)

Study Completion Date

May 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Magna Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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]."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Seasonal

Keywords

Rhinitis, Allergic, Seasonal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AHIST for seasonal allergic rhinitis

Arm Type

Experimental

Arm Description

AHIST for SAR: each green tablet contains 12mg chlorpheniramine tannate.

Intervention Type

Drug

Intervention Name(s)

AHIST NDC#58407-012-01

Intervention Description

Oral tablet containing chlorpheniramine tannate 12mg.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To report any side effects or adverse drug reactions and rate the severity of incidence.

Time Frame

April 2011

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen J Pollard, MD

Organizational Affiliation

Family Allergy and Asthma Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Family Allergy and Asthma Research Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

12. IPD Sharing Statement

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Study of AHIST in Seasonal Allergic Rhinitis Patients

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