Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): STAHIST NDC #58407-536-01
Intervention type(s): Drug
Intervention description(s): Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.
Other intervention name(s): STAHIST NDC#58407-536-01
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rhinitis, Allergic, Seasonal