CompletedPhase 3

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

United States601 participantsStarted 2016-04

Plain-language 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)

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Aged ≥12 years and older inclusive of either sex.
✓. 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

✕. Pregnant or lactating women.
✕. 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

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs).

Timeframe: 52 weeks

Trial details

NCT IDNCT02709538

SponsorGlenmark Specialty S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07

Results submitted2018-07-23

View on ClinicalTrials.gov More Perennial Allergic Rhinitis trials