Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR) (GSP 301-305)
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| ClinicalTrials.gov Identifier: NCT03463031 |
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Recruitment Status :
Completed
First Posted : March 13, 2018
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
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Sponsor:
Glenmark Specialty S.A.
Information provided by (Responsible Party):
Glenmark Specialty S.A.
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Seasonal Allergic Rhinitis (SAR) | Drug: GSP 301 NS Drug: GSP 301 Placebo NS | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 446 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 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) |
| Actual Study Start Date : | March 16, 2018 |
| Actual Primary Completion Date : | November 14, 2018 |
| Actual Study Completion Date : | November 14, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: GSP 301 NS
Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS
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Drug: GSP 301 NS
1 spray in each nostril twice daily for 14 days |
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Placebo Comparator: GSP 301 Placebo NS
GSP 301 Placebo nasal spray
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Drug: GSP 301 Placebo NS
1 spray in each nostril twice daily for 14 days |
Primary Outcome Measures :
- Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period [ 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). 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.
Secondary Outcome Measures :
- Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period. [ Time Frame: Baseline and day 14 ]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.
- Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4) [ Time Frame: Baseline and day 15 ]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.
- Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period. [ Time Frame: Baseline and day 14 ]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.
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| Ages Eligible for Study: | 6 Years to 11 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects aged ≥6 to <12 years
- Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
- Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
- A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
- Signed informed consent/assent form (subject and parent/caregiver/legal guardian)
Exclusion Criteria:
- Females of childbearing potential or pregnant
- 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.
- History of anaphylaxis and/or other severe local reaction(s) to skin testing
- History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip
- Subjects with an active pulmonary disorder or infection.
- Subjects with posterior subcapsular cataracts or glaucoma
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): NCT03463031
Locations
Show 32 study locations
Sponsors and Collaborators
Glenmark Specialty S.A.
Investigators
| Study Director: | Sudeesh Tantry, PhD | Glenmark Pharmaceuticals Ltd. |
Study Documents (Full-Text)
Documents provided by Glenmark Specialty S.A.:
Documents provided by Glenmark Specialty S.A.:
Study Protocol [PDF] July 18, 2018
Statistical Analysis Plan [PDF] December 6, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Glenmark Specialty S.A. |
| ClinicalTrials.gov Identifier: | NCT03463031 |
| Other Study ID Numbers: |
GSP 301-305 |
| First Posted: | March 13, 2018 Key Record Dates |
| Results First Posted: | October 8, 2019 |
| Last Update Posted: | October 8, 2019 |
| Last Verified: | September 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Glenmark Specialty S.A.:
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GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis |
Additional relevant MeSH terms:
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Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Respiratory Tract Infections Infections Nose Diseases |
Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |