Phase 3 N=446 Randomized Quadruple-blind Treatment

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)

Bottom Line

View on ClinicalTrials.gov: NCT03463031 ↗

Enrolled (actual)

446

Serious AEs

0.2%

Results posted

Oct 2019

Primary outcome: 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 — 8.83; 8.84; -2.2; -1.6 units on a scale — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: GSP 301 NS (Drug); GSP 301 Placebo NS (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Glenmark Specialty S.A.
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
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	8.83; 8.84; -2.2; -1.6	0.001 sig
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.	7.89; 7.82; -1.8; -1.1	<0.001 sig
SECONDARY Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)	2.51; 2.42; -0.8; -0.5	< 0.001 sig
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.	3.84; 3.59; -0.8; -0.6	0.233

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03463031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.