Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
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.
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.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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