Study of AHIST in Seasonal Allergic Rhinitis Patients

NCT01008397 | Withdrawn Phase 1 DMC

• 1 other identifier: AHIST IND
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Rhinitis, Allergic, Seasonal

Outcome Measures

Primary Outcomes (1)

• To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours.

  April 2011

Secondary Outcomes (1)

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

  April 2011

Study Arms (1)

AHIST for seasonal allergic rhinitis

EXPERIMENTAL

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

Drug: AHIST NDC#58407-012-01

Interventions

AHIST NDC#58407-012-01 DRUG

Oral tablet containing chlorpheniramine tannate 12mg.

AHIST for seasonal allergic rhinitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Magna Pharmaceuticals, Inc.: lead

Study Sites (1)

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40215, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Stephen J Pollard, MD

  Family Allergy and Asthma Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: November 5, 2009
• Study Start: April 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 6, 2014

Record last verified: 2011-02

Locations

US (1)