NCT02318303

Brief Summary

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,111

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

June 28, 2017

Completed
Last Updated

October 20, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

December 3, 2014

Results QC Date

April 18, 2017

Last Update Submit

September 28, 2020

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Change in rTNSS From Baseline to End of Treatment

    Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching. The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome. The severity scale for each symptom evaluation was defined as follows: * 0 = absent (no sign/symptom evident) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate \[i.e., causes interference with activities of daily living and/or sleeping\])

    14 days

Study Arms (7)

GSP 301 Placebo NS

PLACEBO COMPARATOR
Drug: GSP 301 Placebo NS

GSP 301-1 NS (QD)

EXPERIMENTAL
Drug: GSP 301-1 NS (QD)

GSP 301-2 NS (BID)

EXPERIMENTAL
Drug: GSP 301-2 NS (BID)

Olopatadine HCl-1 NS (QD)

ACTIVE COMPARATOR
Drug: Olopatadine HCl-1 NS (QD)

Olopatadine HCl-2 NS (BID)

ACTIVE COMPARATOR
Drug: Olopatadine HCl-2 NS (BID)

Mometasone Furoate-1 NS (QD)

ACTIVE COMPARATOR
Drug: Mometasone Furoate-1 NS (QD)

Mometasone Furoate-2 NS (BID)

ACTIVE COMPARATOR
Drug: Mometasone Furoate-2 NS (BID)

Interventions

GSP 301-1 NS (QD)DRUG

GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril

GSP 301-1 NS (QD)
GSP 301-2 NS (BID)DRUG

GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril

GSP 301-2 NS (BID)
GSP 301 Placebo NSDRUG

GSP 301 placebo NS administered as 2 sprays/nostril

GSP 301 Placebo NS
Olopatadine HCl-1 NS (QD)DRUG

Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril

Olopatadine HCl-1 NS (QD)
Olopatadine HCl-2 NS (BID)DRUG

Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril

Olopatadine HCl-2 NS (BID)
Mometasone Furoate-1 NS (QD)DRUG

Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril

Mometasone Furoate-1 NS (QD)
Mometasone Furoate-2 NS (BID)DRUG

Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril

Mometasone Furoate-2 NS (BID)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥12 years and older inclusive of either sex.
  • Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) during the study season for the mountain cedar pollen
  • A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).

You may not qualify if:

  • Pregnant or lactating women.
  • Plans to travel outside the known pollen area for the investigative site for \> 24 hours during the last 7 days of run in period.
  • History of nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
  • History of anaphylaxis and/or other severe local reaction(s) to skin testing.
  • History of positive test for HIV, Hepatitis B or Hepatitis C infection.
  • Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
  • Subjects with an active pulmonary disorder or infection.
  • Subjects with posterior subcapsular cataracts or glaucoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Glenmark Investigational Site 10

Austin, Texas, United States

Location

Glenmark Investigational Site 5

Austin, Texas, United States

Location

Glenmark Investigational Site 6

Austin, Texas, United States

Location

Glenmark Investigational Site 2

Kerrville, Texas, United States

Location

Glenmark Investigational Site 7

New Braunfels, Texas, United States

Location

Glenmark Investigational Site 3

San Antonio, Texas, United States

Location

Glenmark Investigational Site 4

San Antonio, Texas, United States

Location

Glenmark Investigational Site 8

San Antonio, Texas, United States

Location

Glenmark Investigational Site 9

San Antonio, Texas, United States

Location

Glenmark Investigational Site 1

Waco, Texas, United States

Location

Related Publications (1)

  • Andrews CP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 10.1016/j.anai.2019.11.007. Epub 2019 Nov 15.

    PMID: 31734334DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Cathy Tyrrell
Organization
Glenmark Pharmaceuticals Ltd
clinicaltrialsdisclosuredesk@glenmarkpharma.com
91 2267720000

Study Officials

  • Sudeesh Tantry, Ph.D

    Glenmark Pharmaceuticals Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 17, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 20, 2020

Results First Posted

June 28, 2017

Record last verified: 2020-09

Locations

US(10)