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NCT02631551 Clinical Trial

Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)

Seasonal Allergic Rhinitis Clinical Trial

— GSP 301-301  

Official title:
A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02631551
Other study ID # GPL/CT/2014/016/III
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2016
Est. completion date July 2016

Study information
Verified date August 2018
Source Glenmark Specialty S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

Recruitment information / eligibility
Status Completed
Enrollment 1180
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 spring allergy season (tree/grass 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 anaphylaxis and/or other severe local reaction(s) to skin testing.

4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

5. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.

6. Subjects with an active pulmonary disorder or infection.

7. Subjects with posterior subcapsular cataracts or glaucoma

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GSP 301 NS
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
• Olopatadine HCl NS
2 sprays in each nostril twice daily for 14 days
• Mometasone furoate NS
2 sprays in each nostril twice daily for 14 days
• GSP 301 Placebo NS
2 sprays in each nostril twice daily for 14 days

Locations
Country Name City State
United States Investigational Site 3 Austin Texas
United States Investigational Site 5 Austin Texas
United States Investigational Site 8 Austin Texas
United States Investigational Site 14 Baltimore Maryland
United States Investigational Site 16 Bellevue Nebraska
United States Investigational Site 25 Centennial Colorado
United States Investigational Site 27 Cincinnati Ohio
United States Investigational Site 22 Colorado Springs Colorado
United States Investigational Site 24 Draper Utah
United States Investigational Site 10 Jupiter Florida
United States Investigational Site 1 Kerrville Texas
United States Investigational Site 11 Louisville Kentucky
United States Investigational Site 37 Marietta Georgia
United States Investigational Site 32 Medford Oregon
United States Investigational Site 30 Miami Florida
United States Investigational Site 34 Middleburg Heights Ohio
United States Investigational Site 19 Minneapolis Minnesota
United States Investigational Site 20 Mission Viejo California
United States Investigational Site 7 New Braunfels Texas
United States Investigational Site 13 Orangeburg South Carolina
United States Investigational Site 35 Portland Oregon
United States Investigational Site 18 Raleigh North Carolina
United States Investigational Site 36 Rochester New York
United States Investigational Site 21 Saint Louis Missouri
United States Investigational Site 2 San Antonio Texas
United States Investigational Site 4 San Antonio Texas
United States Investigational Site 6 San Antonio Texas
United States Investigational Site 9 San Antonio Texas
United States Investigational Site 31 San Diego California
United States Investigational Site 29 San Jose California
United States Investigational Site 12 Skillman New Jersey
United States Investigational Site 17 Spartanburg South Carolina
United States Investigational Site 15 Stockbridge Georgia
United States Investigational Site 23 Stockbridge Georgia
United States Investigational Site 28 Waco Texas
United States Investigational Site 33 Wheaton Maryland
United States Investigational Site 26 Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
Glenmark Specialty S.A.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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). 14 days
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