Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: GSP 301 NS; Drug: GSP 301 Placebo NS pH 7.0; Drug: GSP 301 Placebo NS pH 3.7

• Registration Number: NCT02709538
• Lead Sponsor: Glenmark Specialty S.A.

Brief Summary

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-16
• Study Start: 2016-04
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2018-07-23
• Results First Submitted QC: 2018-08-17
• Results First Posted: 2018-09-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

Inclusion Criteria

1. Aged ≥12 years and older inclusive of either sex.
2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.

Exclusion Criteria

1. Pregnant or lactating women.
2. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
3. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
4. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
5. Subjects with an active pulmonary disorder or infection.
6. Subjects with posterior subcapsular cataracts or glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSP 301 NS	GSP 301 NS	-
GSP 301 Placebo NS pH 7.0	GSP 301 Placebo NS pH 7.0	-
GSP 301 Placebo NS pH 3.7	GSP 301 Placebo NS pH 3.7	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs).	52 weeks	All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.

Trial Locations

Locations (34)

Investigational Site 2; 🇺🇸 Hot Springs, Arkansas, United States

Investigational Site 28; 🇺🇸 Encinitas, California, United States

Investigational Site 27; 🇺🇸 San Diego, California, United States

Investigational Site 29; 🇺🇸 San Diego, California, United States

Investigational Site 32; 🇺🇸 Denver, Colorado, United States

Investigational Site 26; 🇺🇸 Aventura, Florida, United States

Investigational Site 9; 🇺🇸 Miami, Florida, United States

Investigational Site 33; 🇺🇸 Tallahassee, Florida, United States

Investigational Site 11; 🇺🇸 Stockbridge, Georgia, United States

Investigational Site 4; 🇺🇸 Louisville, Kentucky, United States

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