Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||STAHIST IND 105781 Phase 1 Clinical Trial|
- To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredients in STAHIST over the dosage interval period of 12 hours. [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]
- To report any side effects or adverse drug reactions and rate the severity of incidence. [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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 Name: STAHIST NDC#58407-536-01
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932256
|United States, Kentucky|
|Family Allergy and Asthma Research Institute|
|Louisville, Kentucky, United States, 40215|
|Principal Investigator:||Stephen J Pollard, MD||Family Allergy and Asthma Research Institute|