Seasonal Allergic Rhinitis Clinical Trial
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01337323 -
Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
|
N/A | |
| Completed |
NCT01171664 -
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects
|
Phase 2 | |
| Completed |
NCT00784732 -
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
|
Phase 2 | |
| Completed |
NCT00578929 -
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
|
Phase 3 | |
| Completed |
NCT00619827 -
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
|
Phase 1 | |
| Completed |
NCT00209365 -
The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit
|
N/A | |
| Terminated |
NCT00223587 -
Seasonal Allergic Rhinitis and Driving Ability
|
Phase 4 | |
| Completed |
NCT00637455 -
Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
|
Phase 4 | |
| Completed |
NCT00963599 -
Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
|
Phase 3 | |
| Recruiting |
NCT05346718 -
Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis
|
N/A | |
| Completed |
NCT06126952 -
Azelastine Allergen Chamber - Onset of Action Study
|
Phase 2 | |
| Completed |
NCT01940146 -
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
|
Phase 2 | |
| Completed |
NCT02245360 -
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
|
Phase 3 | |
| Completed |
NCT01230619 -
Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
|
Phase 2 | |
| Completed |
NCT00561717 -
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis
|
Phase 4 | |
| Completed |
NCT00574210 -
PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)
|
Phase 2 | |
| Completed |
NCT00443495 -
Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis
|
Phase 1/Phase 2 | |
| Completed |
NCT00420082 -
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
|
Phase 2 | |
| Completed |
NCT00405899 -
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
|
N/A | |
| Completed |
NCT03097432 -
Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment
|
N/A |