Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects
| Status: | Completed |
|---|---|
| Conditions: | Allergy |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/14/2017 |
| Start Date: | September 2010 |
| End Date: | January 2011 |
A Bi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult Subjects With a History of Seasonal Allergic Rhinitis
To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom
scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on
placebo.
scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on
placebo.
This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST
vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two
years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR
symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching,
sneezing, and post-nasal drip.
vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two
years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR
symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching,
sneezing, and post-nasal drip.
Inclusion Criteria:
1. Males and females of any ethnic group between 18 and 60 years of age.
2. History of moderate to severe SAR for at least two years.
3. Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory
tract tissues will include the five symptoms that are th focus of this study: nasal
congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip. Subjects must
have a TSS baseline score of at least 8 on the S5 Subject Diary.
4. Prior to study drug administration, subjects' good health will be confirmed by medical
history and physical examination, including pregnancy test (urine dip) before study
inception.
5. Allergic hypersensitivity will be confirmed by the physician or well established
patient medical history.
6. Subject's compliance with requisite run-in period for each subject will be confirmed
by investigator/designee.
Exclusion Criteria:
1. Pregnancy or lactation.
2. Immunotherapy unless at a stable maintenance dose.
3. 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.
4. Alcohol dependence.
5. Use of any other investigational drug in the previous month.
6. Subjects presenting with asthma requiring corticosteroid treatment.
7. Subjects with multiple drug allergies.
8. Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP
(STAHIST).
9. Subject who is participating in any other clinical study.
10. Subject who is unable to meet washout requirements.
11. Subject with clinically significant abnormal vital sign or laboratory value that
precludes participation.
12. Subject with any family relationship to the sponsor, investigator, or staff of sponsor
or investigator.
13. A URI within 4 weeks of study inception.
14. Subjects taking beta blockers or try-cyclic antidepressants. -
We found this trial at
2
sites
South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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