A Phase 3 interventional study of GSP 301 NS and GSP 301 Placebo NS in Seasonal Allergic Rhinitis (SAR), sponsored by Glenmark Specialty S.A.. Completed at 32 sites in United States. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Glenmark Specialty S.A. · Phase 3, Interventional, and Treatment
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).
Exclusion Criteria:
Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS
Drug: GSP 301 NS
GSP 301 Placebo nasal spray
Drug: GSP 301 Placebo NS
1 spray in each nostril twice daily for 14 days
1 spray in each nostril twice daily for 14 days
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.
Time frame: Baseline and day 14
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.
Time frame: Baseline and day 14
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.
Time frame: Baseline and day 15
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.
Time frame: Baseline and day 14
| Milestone | GSP 301 NS | Placebo NS |
|---|---|---|
| Started | 225 | 221 |
| Completed | 215 | 216 |
| Not completed | 10 | 5 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: Investigator/sponsor decision | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Use of prohibited medication by subject | 1 | 0 |
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.
| units on a scale | GSP 301 NS | Placebo NS |
|---|---|---|
| Baseline | 8.83 ± 1.41 | 8.84 ± 1.66 |
| Mean Change from baseline to end of treatment | -2.2 ± 0.17 | -1.6 ± 0.18 |
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.
| units on a scale | GSP 301 NS | Placebo NS |
|---|---|---|
| Baseline | 7.89 ± 1.93 | 7.82 ± 2.04 |
| Mean Change from baseline to end of treatment | -1.8 ± 0.17 | -1.1 ± 0.17 |
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.
| units on a scale | GSP 301 NS | Placebo NS |
|---|---|---|
| Baseline | 2.51 ± 1.078 | 2.42 ± 1.001 |
| Mean Change from baseline to end of treatment | -0.8 ± 0.08 | -0.5 ± 0.08 |
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.
| units on a scale | GSP 301 NS | Placebo NS |
|---|---|---|
| Baseline | 3.84 ± 2.45 | 3.59 ± 2.52 |
| Mean Change from baseline to end of treatment | -0.8 ± 0.14 | -0.6 ± 0.13 |
Collected over AEs and SAEs were collected from the time of signing the informed consent form (ICF) until the follow up contact which was approximately 22 days and up to 27 days with 7 to 10 days of a placebo run-in period and 14 days of treatment period, with allowable window periods for the study visits.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSP 301 NS | 0/225 (0%) | 0/225 (0%) | 0/225 (0%) |
| Placebo NS | 0/221 (0%) | 1/221 (0.5%) | 0/221 (0%) |
| Event | GSP 301 NS | Placebo NS |
|---|---|---|
| Meningitis viralInfections and infestations | 0/225 | 1/221 |
| Age, Continuous(years) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| Mean | 8.7 ± 1.6 | 8.6 ± 1.7 | 8.7 ± 1.7 |
| Age, Customized(Participants) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| 6 - < 9 | 100 | 99 | 199 |
| 9 - < 12 | 125 | 122 | 247 |
| Sex: Female, Male(Participants) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| Female | 99 | 109 | 208 |
| Male | 126 | 112 | 238 |
| Ethnicity (NIH/OMB)(Participants) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| Hispanic or Latino | 67 | 85 | 152 |
| Not Hispanic or Latino | 158 | 135 | 293 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 5 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 46 | 44 | 90 |
| White | 168 | 169 | 337 |
| More than one race | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 1 | 1 |
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Glenmark Specialty S.A.