Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Seasonal Allergic Rhinitis (SAR) Clinical Trial

— GSP 301-305  

Official title:

A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463031
• Other study ID #: GSP 301-305
• Status: Completed
• Phase: Phase 3
• Start date: March 16, 2018
• Est. completion date: November 14, 2018

Study information

• Verified date: September 2019
• Source: Glenmark Specialty S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: November 14, 2018
• Est. primary completion date: November 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

1. Male and female subjects aged =6 to <12 years

2. Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)

3. Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening

4. A 12-hour rTNSS value =6 out of a possible 12 for the morning assessment at screening

5. Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

Exclusion Criteria:

1. Females of childbearing potential or pregnant

2. 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.

3. History of anaphylaxis and/or other severe local reaction(s) to skin testing

4. History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip

5. Subjects with an active pulmonary disorder or infection.

6. Subjects with posterior subcapsular cataracts or glaucoma

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis (SAR)

Intervention

Drug:
• GSP 301 NS
1 spray in each nostril twice daily for 14 days
• GSP 301 Placebo NS
1 spray in each nostril twice daily for 14 days

Locations

Country	Name	City	State
United States	Glenmark Investigational Site 5	Austin	Texas
United States	Glenmark Investigational Site 14	Baltimore	Maryland
United States	Glenmark Investigational Site 19	Bethesda	Maryland
United States	Glenmark Investigational Site 11	Cincinnati	Ohio
United States	Glenmark Investigational Site 29	Cincinnati	Ohio
United States	Glenmark Investigational Site 21	Colorado Springs	Colorado
United States	Glenmark Investigational Site 12	Columbia	Missouri
United States	Glenmark Investigational Site 22	Draper	Utah
United States	Glenmark Investigational Site 2	Edmond	Oklahoma
United States	Glenmark Investigational Site 23	Greenfield	Wisconsin
United States	Glenmark Investigational Site 3	High Point	North Carolina
United States	Glenmark Investigational Site 24	Kerrville	Texas
United States	Glenmark Investigational Site 28	Louisville	Kentucky
United States	Glenmark Investigational Site 13	Marietta	Georgia
United States	Glenmark Investigational Site 4	Medford	Oregon
United States	Glenmark Investigational Site 18	Mission Viejo	California
United States	Glenmark Investigational Site 1	New Braunfels	Texas
United States	Glenmark Investigational Site 15	Omaha	Nebraska
United States	Glenmark Investigational Site 32	Ontario	California
United States	Glenmark Investigational Site 30	Paramount	California
United States	Glenmark Investigational Site 8	Raleigh	North Carolina
United States	Glenmark Investigational Site 10	Rolla	Missouri
United States	Glenmark Investigational Site 7	San Antonio	Texas
United States	Glenmark Investigational Site 9	San Antonio	Texas
United States	Glenmark Investigational Site 17	San Diego	California
United States	Glenmark Investigational Site 26	Savannah	Georgia
United States	Glenmark Investigational Site 6	Spartanburg	South Carolina
United States	Glenmark Investigational Site 33	Tulsa	Oklahoma
United States	Glenmark Investigational Site 20	Waco	Texas
United States	Glenmark Investigational Site 31	Waco	Texas
United States	Glenmark Investigational Site 27	Warrensburg	Missouri
United States	Glenmark Investigational Site 25	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 From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period	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). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the rTNSS is summed. The total score of the rTNSS ranged from 0 to 12.	Baseline and day 14
Secondary	Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.	The instantaneous Total Nasal Symptom Score (iTNSS) was assessed by instantaneous (ie, an evaluation of the symptom severity just before taking study medication [within 10 minutes]) of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the iTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the iTNSS is summed. The total score of the iTNSS ranged from 0 to 12.	Baseline and day 14
Secondary	Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)	The PRQLQ is a validated, disease-specific, quality-of-life (QOL) questionnaire developed to measure the physical, emotional, and social impairments that are experienced by children (aged =6 to <12 years) with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation and other symptoms). Subjects recall how they have been during the previous week and respond to each question on a 7-point scale with scores ranging from 6 (extremely bothered), 5 (very bothered), 4 (quite bothered), 3 (somewhat bothered), 2 (bothered a bit), 1 (hardly bothered at all), 0 (not bothered). The Overall PRQLQ score is the mean of all 23 subject-reported responses. The Overall PRQLQ score range from 0 to 6 where 0 represents no impairment and 6 represents maximum impairment.	Baseline and day 15
Secondary	Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.	The Total Ocular Symptom Score (TOSS) will be calculated using the 3 eye-related non-nasal symptoms: itching/burning eyes, tearing/watering eyes, and redness of eyes. The subject will assess and report his/her non-nasal symptoms twice (AM and PM assessments). Scores ranged from 0 (No sign/symptom evident), 1 (Sign/symptom clearly present but minimal awareness; easily tolerated), 2 (Definite awareness of sign/symptom that is bothersome but tolerable) and 3 (Sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The Total Ocular Symptom Score (TOSS) ranged from 0 to 9.	Baseline and day 14