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To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

Information source: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: GSP 301-1 NS (Drug); GSP 301-2 NS (Drug); Placebo nasal spray (Drug); Olopatadine hydrochloride NS-1 (Drug); Olopatadine hydrochloride NS-2 (Drug); Mometasone furoate NS-1 (Drug); Mometasone furoate NS-2 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Glenmark Pharmaceuticals Ltd. India

Official(s) and/or principal investigator(s):
Sudeesh Tantry, Ph.D, Study Director, Affiliation: Glenmark Pharmaceuticals Ltd


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

Clinical Details

Official title: 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) and With Seasonal Allergic Rhinitis (SAR)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in rTNSS from baseline to end of treatment

Secondary outcome:

Change from baseline in average AM and PM subject-reported 12-hour instantaneous Total Nasal Symptoms Score (iTNSS)

Change from baseline in 12-hour reflective Total Ocular Symptom Score (rTOSS)

Onset of action will be assessed by comparing change from baseline in post-treatment TNSS

Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


Key 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). Key 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 and Contacts

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

Additional Information

Starting date: December 2014
Last updated: May 15, 2015

Page last updated: August 23, 2015

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