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To Study GSP 301 in Patients With Seasonal Allergic Rhinitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)

NCT02318303•Glenmark Pharmaceuticals Ltd. India

View on ClinicalTrials.gov

Summary

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥12 years and older inclusive of either sex.
•2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) during the study season for the mountain cedar pollen
•3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).

Exclusion Criteria

•1. Pregnant or lactating women.
•2. Plans to travel outside the known pollen area for the investigative site for \> 24 hours during the last 7 days of run in period.
•3. History of nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
•4. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
•5. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
•6. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
•7. Subjects with an active pulmonary disorder or infection.
•8. Subjects with posterior subcapsular cataracts or glaucoma.

Locations (10)

Glenmark Investigational Site 10

Austin, Texas, United States

Glenmark Investigational Site 5

Austin, Texas, United States

Glenmark Investigational Site 6

Austin, Texas, United States

Glenmark Investigational Site 2

Kerrville, Texas, United States

Glenmark Investigational Site 7

New Braunfels, Texas, United States

Glenmark Investigational Site 3

San Antonio, Texas, United States

Glenmark Investigational Site 4

San Antonio, Texas, United States

Glenmark Investigational Site 8

San Antonio, Texas, United States

Glenmark Investigational Site 9

San Antonio, Texas, United States

Glenmark Investigational Site 1

Waco, Texas, United States

Key Dates

Start Date

December 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

October 20, 2020

Enrollment

1,111

ACTUAL participants

Conditions

Seasonal Allergic Rhinitis

Interventions

GSP 301-1 NS (QD)

DRUG

GSP 301-2 NS (BID)

DRUG

GSP 301 Placebo NS

DRUG

Olopatadine HCl-1 NS (QD)

DRUG

Olopatadine HCl-2 NS (BID)

DRUG

Mometasone Furoate-1 NS (QD)

DRUG

Mometasone Furoate-2 NS (BID)

DRUG

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

NCT06837233

Seasonal Allergic Rhinitis

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COMPLETEDPHASE1

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

NCT03570957

Seasonal Allergic Rhinitis

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COMPLETEDPHASE3

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray

Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.