CompletedPhase 2

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

United States1,111 participantsStarted 2014-12

Plain-language summary

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

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.

Change in rTNSS From Baseline to End of Treatment

Timeframe: 14 days

NCT IDNCT02318303

SponsorGlenmark Pharmaceuticals Ltd. India

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2017-04-18

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.