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

Overview

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)

Full Title of Study: “A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2017

Interventions

  • Drug: GSP 301 NS
    • FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
  • Drug: GSP 301 Placebo NS pH 3.7
    • 2 spray in each nostril twice daily for 52 weeks
  • Drug: GSP 301 Placebo NS pH 7.0
    • 2 spray in each nostril twice daily for 52 weeks

Arms, Groups and Cohorts

  • Experimental: GSP 301 NS
  • Placebo Comparator: GSP 301 Placebo NS pH 3.7
  • Placebo Comparator: GSP 301 Placebo NS pH 7.0

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Subjects With Treatment-emergent Adverse Events (TEAEs).
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Glenmark Specialty S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sudeesh Tantry, Study Director, Glenmark Pharmaceuticals

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