Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1408 participants
INTERVENTIONAL
2012-10-31
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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Cat-Pad Treatment 1
Cat-PAD Treatment 1
Cat-PAD
1 dose every 4 weeks
Cat-PAD Treatment 2
Cat-PAD Treatment regimen 2
Cat-PAD
1 dose every 4 weeks
Placebo
1 dose every 4 weeks
Placebo
Placebo
Placebo
1 dose every 4 weeks
Interventions
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Cat-PAD
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 cats for at least 2 years.
* Subjects may optionally also have GINA Step 1 controlled asthma.
* Positive skin prick test to cat hair.
* Cat dander specific IgE ≥0.35 kU/L.
Exclusion Criteria
* FEV1 \<80% of predicted.
* Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
* Skin prick test 5 mm greater than the negative control to perennial allergens or animal dander (other than cat) which cannot be avoided during the study.
* 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.
12 Years
65 Years
ALL
No
Sponsors
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inVentiv Health Clinical
OTHER
Pharm-Olam International
INDUSTRY
Circassia Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Harold Nelson, MD
Role: PRINCIPAL_INVESTIGATOR
Jewish National Health
Locations
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Rolling Hills Estates, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Wheat Ridge, Colorado, United States
Eagle, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Forrest, Illinois, United States
Normal, Illinois, United States
Iowa City, Iowa, United States
Overland Park, Kansas, United States
Bangor, Maine, United States
Brockton, Massachusetts, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Bozeman, Montana, United States
Missoula, Montana, United States
Bellevue, Nebraska, United States
Fremont, Nebraska, United States
Omaha, Nebraska, United States
Ocean Township, New Jersey, United States
Albuquerque, New Mexico, United States
Corning, New York, United States
Newburgh, New York, United States
Fargo, North Dakota, United States
Minot, North Dakota, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
Sylvania, Ohio, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Lake Oswego, Oregon, United States
Medford, Oregon, United States
Portland, Oregon, United States
Blue Bell, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Draper, Utah, United States
Glen Allen, Virginia, United States
South Burlington, Virginia, United States
Warrenton, Virginia, United States
Spokane, Washington, United States
Greenfield, Wisconsin, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Burlington, Ontario, Canada
Corruna, Ontario, Canada
Hamilton, Ontario, Canada
Kanata, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Niagara Falls, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Trois-Rivières, Quebec, Canada
Brnho, , Czechia
Čáslav, , Czechia
České Budějovice, , Czechia
Jablonec nad Nisou, , Czechia
Kutná Hora, , Czechia
Prague, , Czechia
Rychnov nad Kněžnou, , Czechia
Berlin, , Germany
Bonn, , Germany
Bramsche, , Germany
Cologne, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Mönchengladbach, , Germany
München, , Germany
Münster, , Germany
Neuss, , Germany
Osnabrück, , Germany
Wesel, , Germany
Wiesbaden, , Germany
Wuppertal, , Germany
Budapest, , Hungary
Csorna, , Hungary
Pécs, , Hungary
Tatabánya, , Hungary
Bydgoszcz, , Poland
Gdansk, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Rzeszów, , Poland
Tarnów, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Zawadzkie, , Poland
Barnaul, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Stavropol, , Russia
Tomsk, , Russia
Yekaterinburg, , Russia
Bardejov, , Slovakia
Martin, , Slovakia
Poprad, , Slovakia
Countries
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Other Identifiers
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CP007
Identifier Type: -
Identifier Source: org_study_id
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