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Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-304)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02870205
Recruitment Status : Completed
First Posted : August 17, 2016
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Glenmark Specialty S.A.

Brief Summary:
Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis (SAR) Drug: GSP 301 NS Drug: GOM-NS Drug: GMM-2 NS Drug: GSP 301 placebo NS Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)
Actual Study Start Date : August 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: GSP 301 NS Drug: GSP 301 NS
2 spray in each nostril twice daily for 14 days

Active Comparator: GOM-NS Drug: GOM-NS
2 spray in each nostril twice daily for 14 days

Active Comparator: GMM-2 NS Drug: GMM-2 NS
2 spray in each nostril twice daily for 14 days

Placebo Comparator: GSP 301 placebo NS Drug: GSP 301 placebo NS
2 spray in each nostril twice daily for 14 days




Primary Outcome Measures :
  1. Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: Baseline and day 14 ]
    The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and non-pregnant females who are 12 years of age and older.
  • Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
  • A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).

Exclusion Criteria:

  • Pregnant or lactating women.
  • History of anaphylaxis and/or other severe local reaction(s) to skin testing.
  • History of positive test for HIV, Hepatitis B or Hepatitis C infection.
  • Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
  • Subjects with an active pulmonary disorder or infection.
  • Subjects with posterior subcapsular cataracts or glaucoma
  • Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870205


Locations
Show Show 43 study locations
Sponsors and Collaborators
Glenmark Specialty S.A.
Investigators
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Study Director: Sudeesh Tantry, PhD Glenmark Pharmaceuticals Ltd

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Glenmark Specialty S.A.
ClinicalTrials.gov Identifier: NCT02870205    
Other Study ID Numbers: GPL/CT/2015/004/III
Study Number: GSP 301-304 ( Other Identifier: Glenmark Specialty S.A. )
First Posted: August 17, 2016    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases