Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:9/27/2018
Start Date:March 2016
End Date:July 2016

Use our guide to learn which trials are right for you!

A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to
individual monotherapies (comparators) as well as the efficacy of these monotherapies
(comparators) versus placebo NS over 14 days of study treatment


Inclusion Criteria:

1. Aged 12 years and older inclusive of either sex.

2. 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 spring
allergy season (tree/grass pollen)

3. 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).

Exclusion Criteria:

1. Pregnant or lactating women.

2. Plans to travel outside the known pollen area for the investigative site for > 24
hours during the last 7 days of run in period.

3. History of anaphylaxis and/or other severe local reaction(s) to skin testing.

4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

5. Documented evidence of acute or significant chronic sinusitis or chronic purulent
postnasal drip.

6. Subjects with an active pulmonary disorder or infection.

7. Subjects with posterior subcapsular cataracts or glaucoma
We found this trial at
36
sites
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
?
mi
from
Centennial, CO
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Draper, UT
Click here to add this to my saved trials
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
?
mi
from
Kerrville, TX
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Medford, OR
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mission Viejo, California 92691
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
?
mi
from
New Braunfels, TX
Click here to add this to my saved trials
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Jose, CA
Click here to add this to my saved trials
?
mi
from
Skillman, NJ
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
?
mi
from
Waco, TX
Click here to add this to my saved trials
?
mi
from
Wheaton, MD
Click here to add this to my saved trials
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials