Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
715 participants
INTERVENTIONAL
2014-09-30
2017-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HMD-SPIRE Treatment 1
4 x 12 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart
HDM-SPIRE
1 dose every 4 weeks
Placebo
1 dose every 4 weeks
HDM-SPIRE Treatment 2
4 x 12 nmol HDM-SPIRE 4 weeks apart followed by a second course of 4 x 12 nmol HDM-SPIRE 4 weeks apart
HDM-SPIRE
1 dose every 4 weeks
HDM-SPIRE Treatment 3
4 x 20 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart
HDM-SPIRE
1 dose every 4 weeks
Placebo
1 dose every 4 weeks
Placebo
8 x placebo 4 weeks apart
Placebo
1 dose every 4 weeks
Interventions
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HDM-SPIRE
1 dose every 4 weeks
Placebo
1 dose every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
Circassia Limited
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Huntington Beach, California, United States
Long Beach, California, United States
Mission Viejo, California, United States
Napa, California, United States
Orange, California, United States
Redwood City, California, United States
Rolling Hills Estates, California, United States
Roseville, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Waterbury, Connecticut, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Stockbridge, Georgia, United States
Normal, Illinois, United States
Shiloh, Illinois, United States
Evansville, Indiana, United States
Iowa City, Iowa, United States
Owensboro, Kentucky, United States
Bangor, Maine, United States
Bethesda, Maryland, United States
Gaithersburg, Maryland, United States
Brockton, Massachusetts, United States
Minneapolis, Minnesota, United States
Plymouth, Minnesota, United States
St Louis, Missouri, United States
Bellevue, Nebraska, United States
Ocean City, New Jersey, United States
Teaneck, New Jersey, United States
Verona, New Jersey, United States
Rochester, New York, United States
Rockville Centre, New York, United States
Asheville, North Carolina, United States
High Point, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Blue Bell, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Kerrville, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
South Burlington, Vermont, United States
Henrico, Virginia, United States
Bellingham, Washington, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Greenfield, Wisconsin, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Hamilton, Ontario, Canada
London, Ontario, Canada
Niagara, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saint Romuald, Quebec, Canada
Trois-Rivières, Quebec, Canada
Reims, Marne, France
Gironde, Pessac, France
Bas Rhin, Strasbourg, France
Meurthe-et-Moselle, Vandoeuvre Les Nancy, France
Heidelberg, Baden-Wurttemberg, Germany
Essen, North Rhine-Westphalia, Germany
Goch, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Berlin, , Germany
Hamburg, , Germany
Ancona, Torrette Di Ancona, Italy
Genova, , Italy
Milan, , Italy
Parma, , Italy
Pavia, , Italy
Roma, , Italy
Siena, , Italy
Almere Stad, , Netherlands
Amsterdam, , Netherlands
Beek, , Netherlands
Durban, KwaZulu-Natal, South Africa
eMkhomazi, KwaZulu-Natal, South Africa
Ottawa, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Sabadell, Barcelona, Spain
Santander, Cantabria, Spain
Girona, Catalonia, Spain
Donostia / San Sebastian, Guipuzcoa, Spain
Pamplona, Navarre, Spain
Bilbao, Vizcaya, Spain
Barcelona, , Spain
Seville, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TH005
Identifier Type: -
Identifier Source: org_study_id
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