Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects - Full Text View

Purpose

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.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Placebo Drug: STAHIST	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

U.S. FDA Resources

Further study details as provided by Magna Pharmaceuticals, Inc.:

Primary Outcome Measures:

Total Symptom Scores(TSS)reported and compared between the two study arms [ Time Frame: Twice daily over the 2 week study period ] [ Designated as safety issue: No ]
TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip

Secondary Outcome Measures:

Adverse events--report and assess [ Time Frame: Continuous over the two week study period ] [ Designated as safety issue: Yes ]
Any/all adverse events will be recorded and scored, reported, evaluated, and results will be clinically and statistically compared between the placebo and active drug arms.

Enrollment:	100
Study Start Date:	September 2010
Study Completion Date:	January 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo containing no active pharmaceutical ingredients	Drug: Placebo Tablet, one BID
Experimental: STAHIST STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis	Drug: STAHIST STAHIST in tablet form dosed one BID

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females of any ethnic group between 18 and 60 years of age.
History of moderate to severe SAR for at least two years.
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.
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.
Allergic hypersensitivity will be confirmed by the physician or well established patient medical history.
Subject's compliance with requisite run-in period for each subject will be confirmed by investigator/designee.

Exclusion Criteria:

Pregnancy or lactation.
Immunotherapy unless at a stable maintenance dose.
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.
Alcohol dependence.
Use of any other investigational drug in the previous month.
Subjects presenting with asthma requiring corticosteroid treatment.
Subjects with multiple drug allergies.
Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP (STAHIST).
Subject who is participating in any other clinical study.
Subject who is unable to meet washout requirements.
Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.
Subject with any family relationship to the sponsor, investigator, or staff of sponsor or investigator.
A URI within 4 weeks of study inception.
Subjects taking beta blockers or try-cyclic antidepressants. -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171664

Locations

United States, Indiana
The South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Kentucky
Family Allergy & Asthma Research Institute
Louisville, Kentucky, United States, 40215

Sponsors and Collaborators

Magna Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Stephen J Pollard, MD

Family Allergy & Asthma Research Institute

More Information

No publications provided

Responsible Party:	Warren P. Lesser, President/CEO, MAGNA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01171664 History of Changes
Other Study ID Numbers:	105781-2
Study First Received:	July 27, 2010
Last Updated:	February 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Magna Pharmaceuticals, Inc.:

Phase 2
SAR
STAHIST

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity

Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 16, 2013

Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects (STA-2)