Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients

STAHIST IND 105781 Phase 1 Clinical Trial

MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase 1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements and blood levels of active ingredients over 12 hours; 2) To report subjective scores by subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse drug reactions and rate the severity of incidence.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Seasonal
• Intervention / Treatment: Drug: STAHIST NDC #58407-536-01

Detailed Description

No procedure will be performed until Informed Consent has been obtained. Inclusion and exclusion criteria will be verified. Subjects will be required to stop using oral nasal decongestants or first generation antihistamines for 48 hours, second generation antihistamines and Singulair for seven days, systemic corticosteroids for 30 days, and nasal or ocular corticosteroid medications for two weeks. Use of these drugs will not be allowed during the study.

Blood samples will be drawn at specific time points: baseline fasting blood draw just before 7AM, then at 9 AM, 11AM, 3PM, and 7PM. A single oral dose of STAHIST will be administered at 7AM.

During the study a diary of the five study symptoms (S5 Diary) will be scored hourly over the 12-hour period as follows: 0 none, 1 mild, 2 moderate, 3 severe. The S5 symptoms are 1. Nasal Congestion (Stuffiness); 2. Sneezing; 3. Rhinorrhea (runny nose); 4. Nasal Itching; 5. Post-nasal drip. Post nasal drip is defined for the patient as "you can feel accumulated mucus dripping down the back of your throat from your sinuses, also possibly including a tickly cough or sore throat due to this sensation of mucus."

Side effects or adverse drug reactions will be scored if they occur and hourly as 1 mild, 2 moderate, and 3 severe. Any adverse events will be recorded. Any subject who is not able or who is unwilling to continue keeping a diary or participate in blood draws will be permitted to withdraw from the study. Safety will be assured by the frequent visible assessment and questioning of subjects as well as monitoring of subjects' vital signs by Dr. Pollard and his nursing staff. Subjects will remain in the clinic during the 12-hour dosage interval. Thereafter, Dr. Pollard and selected staff will be on call 24 hours to answer any subject phone calls.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Family Allergy and Asthma Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females of any ethnic group between the ages of 18 and 60 years of age.
• History of moderate to severe SAR for at least one year.

• Subjects' symptoms will include the five symptoms ("S5") that are the focus of this study:

  • nasal congestion;
  • rhinorrhea;
  • nasal itching;
  • sneezing;
  • post nasal drip.
• Prior to study subjects' good health will be confirmed by medical history and physical examination.
• Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established 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 STAHIST.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAHIST for seasonal allergic rhinitis; STAHIST for seasonal allergic rhinitis: each white, scored tablet contains pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, and atropine sulfate .24mg	Drug: STAHIST NDC #58407-536-01; Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.; Other Names: STAHIST NDC#58407-536-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredients in STAHIST over the dosage interval period of 12 hours.	August 2009

Secondary Outcome Measures

Outcome Measure	Time Frame
To report any side effects or adverse drug reactions and rate the severity of incidence.	August 2009

Collaborators and Investigators

• Sponsor: Magna Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Stephen J Pollard, MD, Family Allergy and Asthma Research Institute

Publications and helpful links

General Publications

• Moffitt EM. Symptomatic management of upper respiratory allergies. J Miss State Med Assoc. 1968 Apr;9(4):159-61. No abstract available.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 30, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (Estimate): July 3, 2009

Study Record Updates

• Last Update Posted (Estimate): December 8, 2010
• Last Update Submitted That Met QC Criteria: December 6, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Rhinitis, Allergic, Seasonal
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: STAHIST IND 105781