Phase II HDM-SPIRE Safety and Efficacy Study



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 65
Updated:6/17/2018
Start Date:September 2014
End Date:April 13, 2017

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

A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis

The purpose of this study is to compare the treatment effect of three treatment regimens of
HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue
medication usage, Quality of Life and Sleep Quality


Inclusion Criteria:

- Male or female, aged 18-65 years.

- Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.

- Mean TRSS ≥10

- Positive skin prick test to Der p and Der f.

- Dep p and Der f specific IgE ≥0.7 kU/L

Exclusion Criteria:

- Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3
(www.ginasthma.org)or higher treatment

- FEV1 <80% of predicted.

- Clinically significant confounding symptoms of allergy to seasonal allergens during
the final evaluation period.

- Significant symptoms of another clinically relevant illness that is likely to affect
scoring of rhinoconjunctivitis symptoms.

- Clinically relevant abnormalities detected on physical examination.

- History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
We found this trial at
57
sites
661
mi
from 43215
Tallahassee, FL
Click here to add this to my saved trials
302
mi
from 43215
Asheville, NC
Click here to add this to my saved trials
798
mi
from 43215
Bangor, ME
Click here to add this to my saved trials
679
mi
from 43215
Bellevue, NE
Click here to add this to my saved trials
2015
mi
from 43215
Bellingham, WA
Click here to add this to my saved trials
323
mi
from 43215
Bethesda, MD
Click here to add this to my saved trials
405
mi
from 43215
Bethlehem, PA
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
409
mi
from 43215
Blue Bell, PA
Click here to add this to my saved trials
642
mi
from 43215
Brockton, MA
Click here to add this to my saved trials
103
mi
from 43215
Canton, OH
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
280
mi
from 43215
Evansville, IN
Click here to add this to my saved trials
315
mi
from 43215
Gaithersburg, MD
Click here to add this to my saved trials
330
mi
from 43215
Greenfield, WI
Click here to add this to my saved trials
279
mi
from 43215
Hamilton,
Click here to add this to my saved trials
345
mi
from 43215
Henrico, VA
Click here to add this to my saved trials
322
mi
from 43215
High Point, NC
Click here to add this to my saved trials
Huntington Beach, California 92646
1967
mi
from 43215
Huntington Beach, CA
Click here to add this to my saved trials
460
mi
from 43215
Iowa City, IA
Click here to add this to my saved trials
1137
mi
from 43215
Kerrville, TX
Click here to add this to my saved trials
1975
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
394
mi
from 43215
Madison, WI
Click here to add this to my saved trials
2058
mi
from 43215
Medford, OR
Click here to add this to my saved trials
335
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
624
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
Mission Viejo, California 92691
1953
mi
from 43215
Mission Viejo, CA
Click here to add this to my saved trials
2090
mi
from 43215
Napa, CA
Click here to add this to my saved trials
316
mi
from 43215
Normal, IL
Click here to add this to my saved trials
451
mi
from 43215
Ocean City, NJ
Click here to add this to my saved trials
1959
mi
from 43215
Orange, CA
Click here to add this to my saved trials
266
mi
from 43215
Owensboro, KY
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
896
mi
from 43215
Plano, TX
Click here to add this to my saved trials
635
mi
from 43215
Plymouth, MN
Click here to add this to my saved trials
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
619
mi
from 43215
Providence, RI
Click here to add this to my saved trials
2105
mi
from 43215
Redwood City, CA
Click here to add this to my saved trials
355
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
Rockville Centre, New York 11570
496
mi
from 43215
Rockville Centre, NY
Click here to add this to my saved trials
Rolling Hills Estates, California 90274
1986
mi
from 43215
Rolling Hills Estates, CA
Click here to add this to my saved trials
2028
mi
from 43215
Roseville, CA
Click here to add this to my saved trials
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
380
mi
from 43215
Shiloh, IL
Click here to add this to my saved trials
South Burlington, Vermont 05403
590
mi
from 43215
South Burlington, VT
Click here to add this to my saved trials
448
mi
from 43215
Stockbridge, GA
Click here to add this to my saved trials
831
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
477
mi
from 43215
Teaneck, NJ
Click here to add this to my saved trials
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
2026
mi
from 43215
Vancouver, WA
Click here to add this to my saved trials
465
mi
from 43215
Verona, NJ
Click here to add this to my saved trials
2083
mi
from 43215
Walnut Creek, CA
Click here to add this to my saved trials
533
mi
from 43215
Waterbury, CT
Click here to add this to my saved trials