Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients

NCT ID: NCT00932256

Last Updated: 2010-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Rhinitis, Allergic, Seasonal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

STAHIST NDC #58407-536-01

Intervention Type: DRUG

Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.

Interventions

STAHIST NDC #58407-536-01

Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.

Intervention Type: DRUG

Other Intervention Names

STAHIST NDC#58407-536-01

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magna Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

MAGNA Pharmaceuticals, Inc.

Principal Investigators

Stephen J Pollard, MD

Role: PRINCIPAL_INVESTIGATOR

Family Allergy and Asthma Research Institute

Locations

Family Allergy and Asthma Research Institute

Louisville, Kentucky, United States

Countries

United States

References

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

Reference Type: RESULT

PMID: 5640510 (View on PubMed)

Other Identifiers

STAHIST IND 105781

Identifier Type: -

Identifier Source: org_study_id

NCT00931658

Identifier Type: -

Identifier Source: nct_alias