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

NCT03463031 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GSP 301-305
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 32

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).

Conditions

Seasonal Allergic Rhinitis (SAR)

Keywords

GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.

  Baseline and day 14

• Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)

  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.

  Baseline and day 14

Study Arms (2)

GSP 301 NS

EXPERIMENTAL

Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS

Drug: GSP 301 NS

GSP 301 Placebo NS

PLACEBO COMPARATOR

GSP 301 Placebo nasal spray

Drug: GSP 301 Placebo NS

Interventions

GSP 301 NS DRUG

1 spray in each nostril twice daily for 14 days

GSP 301 NS

GSP 301 Placebo NS DRUG

1 spray in each nostril twice daily for 14 days

GSP 301 Placebo NS

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Glenmark Specialty S.A.: lead

Study Sites (32)

Glenmark Investigational Site 18

Mission Viejo, California, 19406, United States

Location

Glenmark Investigational Site 32

Ontario, California, 910762, United States

Location

Glenmark Investigational Site 30

Paramount, California, 90723, United States

Location

Glenmark Investigational Site 17

San Diego, California, 92108, United States

Location

Glenmark Investigational Site 21

Colorado Springs, Colorado, 80907, United States

Location

Glenmark Investigational Site 13

Marietta, Georgia, 30060, United States

Location

Glenmark Investigational Site 26

Savannah, Georgia, 31312, United States

Location

Glenmark Investigational Site 28

Louisville, Kentucky, 40215, United States

Location

Glenmark Investigational Site 14

Baltimore, Maryland, 21236-5992, United States

Location

Glenmark Investigational Site 19

Bethesda, Maryland, 20814-2672, United States

Location

Glenmark Investigational Site 25

Ypsilanti, Michigan, 48197, United States

Location

Glenmark Investigational Site 12

Columbia, Missouri, 65203, United States

Location

Glenmark Investigational Site 10

Rolla, Missouri, 65401, United States

Location

Glenmark Investigational Site 27

Warrensburg, Missouri, 64093, United States

Location

Glenmark Investigational Site 15

Omaha, Nebraska, 68114, United States

Location

Glenmark Investigational Site 3

High Point, North Carolina, 27262-4320, United States

Location

Glenmark Investigational Site 8

Raleigh, North Carolina, 27607, United States

Location

Glenmark Investigational Site 11

Cincinnati, Ohio, 45231, United States

Location

Glenmark Investigational Site 29

Cincinnati, Ohio, 45242, United States

Location

Glenmark Investigational Site 2

Edmond, Oklahoma, 73034, United States

Location

Glenmark Investigational Site 33

Tulsa, Oklahoma, 74136, United States

Location

Glenmark Investigational Site 4

Medford, Oregon, 97504-9741, United States

Location

Glenmark Investigational Site 6

Spartanburg, South Carolina, 29303, United States

Location

Glenmark Investigational Site 5

Austin, Texas, 78759, United States

Location

Glenmark Investigational Site 24

Kerrville, Texas, 78028-6071, United States

Location

Glenmark Investigational Site 1

New Braunfels, Texas, 78130, United States

Location

Glenmark Investigational Site 7

San Antonio, Texas, 78229-3749, United States

Location

Glenmark Investigational Site 9

San Antonio, Texas, 78229, United States

Location

Glenmark Investigational Site 20

Waco, Texas, 76712, United States

Location

Glenmark Investigational Site 31

Waco, Texas, 76712, United States

Location

Glenmark Investigational Site 22

Draper, Utah, 84020, United States

Location

Glenmark Investigational Site 23

Greenfield, Wisconsin, 53288, United States

Location

Related Publications (1)

• Prenner BM, Amar NJ, Hampel FC Jr, Caracta CF, Wu W. Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2022 Nov;129(5):618-626.e2. doi: 10.1016/j.anai.2022.07.029. Epub 2022 Aug 1.

  PMID: 35926824 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Glenmark Pharmaceuticals Ltd

clinicaltrialsdisclosuredesk@glenmarkpharma.com

201-684 8000

Study Officials

• Sudeesh Tantry, PhD

  Glenmark Pharmaceuticals Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 13, 2018
• Study Start: March 16, 2018
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-09

Locations

US (32)