Clinical trial NCT02318303: To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
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) With Seasonal Allergic Rhinitis (SAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 1111
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in rTNSS From Baseline to End of Treatment
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Glenmark Investigational Site 10
state: Texas
city: Austin
country: United States
facility: Glenmark Investigational Site 5
state: Texas
city: Austin
country: United States
facility: Glenmark Investigational Site 6
state: Texas
city: Kerrville
country: United States
facility: Glenmark Investigational Site 2
state: Texas
city: New Braunfels
country: United States
facility: Glenmark Investigational Site 7
state: Texas
city: San Antonio
country: United States
facility: Glenmark Investigational Site 3
state: Texas
city: San Antonio
country: United States
facility: Glenmark Investigational Site 4
state: Texas
city: San Antonio
country: United States
facility: Glenmark Investigational Site 8
state: Texas
city: San Antonio
country: United States
facility: Glenmark Investigational Site 9
state: Texas
city: Waco
country: United States
facility: Glenmark Investigational Site 1
state: Texas
Study officials:
affiliation: Glenmark Pharmaceuticals Ltd
name: Sudeesh Tantry, Ph.D
role: STUDY_DIRECTOR
References:
citation: Andrews CP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 10.1016/j.anai.2019.11.007. Epub 2019 Nov 15.