Clinical trial NCT01171664: Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Keywords: Phase 2
SAR
STAHIST
Lead sponsor: Magna Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Total Symptom Scores(TSS)reported and compared between the two study arms
timeFrame: Twice daily over the 2 week study period
Secondary outcomes:
measure: Adverse events--report and assess
timeFrame: Continuous over the two week study period
Other outcomes:
Locations:
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Louisville
country: United States
facility: Family Allergy & Asthma Research Institute
state: Kentucky
Study officials:
affiliation: Family Allergy & Asthma Research Institute
name: Stephen J Pollard, MD
role: PRINCIPAL_INVESTIGATOR
References: