Trial of STAHIST in Seasonal Allergic Rhinitis
Information source: Magna Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: STAHIST (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Magna Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Stephen J Pollard, MD, Principal Investigator, Affiliation: Family Allergy and Asthma Research Institute
Summary
The overall development plan is to show that the combination of tried-and-proven
decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine
maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a
comprehensive, safe and effective B. I.D. drug treatment regimen, indicated for the relief of
symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age
and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose,
itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or
chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the
favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to
assess and compare the safety and efficacy of the study drug in a larger group comparatively
with a placebo control group. Objectives: A) To report and compare total symptom scores
(TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal
congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study
period. B) Report any side effects or adverse drug reactions and rate the severity of any
incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and
post-nasal drip symptom scores (PND-S) between the two study arms.
Clinical Details
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult and Adolescent Subjects With a History of Seasonal Allergic Rhinitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Total Symptom Scores (TSS)
Secondary outcome: Adverse Events (AEs) Assessment
Detailed description:
Phase 3 clinical trial will be conducted in conformance with Good Clinical Practices and is
a multi-center, double-blind, randomized, placebo-controlled, parallel-group study
evaluating the safety and efficacy of STAHIST (IMP) in 300 adult and adolescent subjects
12-60 years of age, of either sex or any race with a minimum 2-year history of seasonal
allergic rhinitis (SAR) and a baseline minimum total symptom score (TSS) of not less than 8
on the S5 Subject Diary. Subjects will be treated twice daily with IMP or placebo for a
period of two weeks. Subjects will visit the study site for at least 4 visits: screening,
randomization/study inception, end-of-week one, final visit, and unscheduled visits as
appropriate.
Run In (washout period): 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 also not be allowed during the study.
The first dose will be administered at the study site and subjects will be monitored on-site
for one hour following dosing. There will be 24-hour on-call telephone access between
physician/office staff and study subjects.
A Study Flow Chart will be used to facilitate trial management, record completed tasks as
well as document their time of completion (See Study Flow Chart and Source
Documents—Appendix D).
Safety evaluations will include monitoring of subject-reported AEs, measurement of vital
signs, and assessment of safety laboratory data. Qualified independent, non-study
administration individuals will be selected prior to the start of treatment for the purpose
of safety monitoring.
300 subjects will be randomized. Assuming a screen failure test rate of approximately 33%,
approximately 450 subjects will be screened.
At the conclusion of the study, the CSR will be prepared by the Sponsor, reviewed and
approved by the Principal/Coordinator Investigator before submission.
Eligibility
Minimum age: 12 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male and females of any ethnic group between 12 and 60 years of age.
2. History of moderate to severe Seasonal Allergic Rhinitis (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 ("S5") that are the focus of
this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal
drip. Subjects must have an average 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 & 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 the individual will be
confirmed by the investigator/designee.
Exclusion Criteria:
1. Pregnancy or lactation.
2. Immunotherapy unless at 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.
9. Subject who has used any investigational drugs within 30 days of the screening visit.
10. Subject who is participating in any other clinical study.
11. Subject who is unable to meet washout requirements.
12. Subject with clinically significant abnormal vital sign or laboratory value that
precludes participation.
13. Subjects with any family relationship to Sponsor, Investigator, or staff of Sponsor
or Investigator.
14. A URI within 4 weeks of study inception.
15. Subjects taking beta blockers or tri-cyclic antidepressants will not be allowed to
participate in the study.
Locations and Contacts
Clinical Research Atlanta, Stockbridge, Georgia 30281, United States
The South Bend Clinic, South Bend, Indiana 46617, United States
Family Allergy and Asthma Institute, Louisville, Kentucky 40215, United States
Family Allergy and Asthma, Somerset, Kentucky 42501, United States
New Horizons Clinical Research, Cincinnati, Ohio 45242, United States
National Allergy, Asthma & Urticaria Centers of Charleston, PA, Charleston, South Carolina 29406, United States
Pharmaceutical Research and Consulting, Inc, Dallas, Texas 75231, United States
Central Texas Health Research, New Braunfels, Texas 78130, United States
Additional Information
Starting date: March 2011
Last updated: August 31, 2011
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