Phase III Cat-PAD Study

NCT ID: NCT01620762

Last Updated: 2018-06-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the treatment effect of two treatment regimens of Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue medication usage and Quality of Life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rhinoconjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cat-Pad Treatment 1

Cat-PAD Treatment 1

Group Type EXPERIMENTAL

Cat-PAD

Intervention Type DRUG

1 dose every 4 weeks

Cat-PAD Treatment 2

Cat-PAD Treatment regimen 2

Group Type EXPERIMENTAL

Cat-PAD

Intervention Type DRUG

1 dose every 4 weeks

Placebo

Intervention Type DRUG

1 dose every 4 weeks

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 dose every 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cat-PAD

1 dose every 4 weeks

Intervention Type DRUG

Placebo

1 dose every 4 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female, aged 12-65 years.
* 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

* Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
* 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

inVentiv Health Clinical

OTHER

Sponsor Role collaborator

Pharm-Olam International

INDUSTRY

Sponsor Role collaborator

Circassia Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harold Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish National Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rolling Hills Estates, California, United States

Site Status

Colorado Springs, Colorado, United States

Site Status

Denver, Colorado, United States

Site Status

Wheat Ridge, Colorado, United States

Site Status

Eagle, Idaho, United States

Site Status

Meridian, Idaho, United States

Site Status

Chicago, Illinois, United States

Site Status

Evanston, Illinois, United States

Site Status

Forrest, Illinois, United States

Site Status

Normal, Illinois, United States

Site Status

Iowa City, Iowa, United States

Site Status

Overland Park, Kansas, United States

Site Status

Bangor, Maine, United States

Site Status

Brockton, Massachusetts, United States

Site Status

Ypsilanti, Michigan, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

Kansas City, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Bozeman, Montana, United States

Site Status

Missoula, Montana, United States

Site Status

Bellevue, Nebraska, United States

Site Status

Fremont, Nebraska, United States

Site Status

Omaha, Nebraska, United States

Site Status

Ocean Township, New Jersey, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Corning, New York, United States

Site Status

Newburgh, New York, United States

Site Status

Fargo, North Dakota, United States

Site Status

Minot, North Dakota, United States

Site Status

Canton, Ohio, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Middleburg Heights, Ohio, United States

Site Status

Sylvania, Ohio, United States

Site Status

Toledo, Ohio, United States

Site Status

Tulsa, Oklahoma, United States

Site Status

Lake Oswego, Oregon, United States

Site Status

Medford, Oregon, United States

Site Status

Portland, Oregon, United States

Site Status

Blue Bell, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Germantown, Tennessee, United States

Site Status

Nashville, Tennessee, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Draper, Utah, United States

Site Status

Glen Allen, Virginia, United States

Site Status

South Burlington, Virginia, United States

Site Status

Warrenton, Virginia, United States

Site Status

Spokane, Washington, United States

Site Status

Greenfield, Wisconsin, United States

Site Status

Madison, Wisconsin, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Brussels, , Belgium

Site Status

Ghent, , Belgium

Site Status

Leuven, , Belgium

Site Status

Burlington, Ontario, Canada

Site Status

Corruna, Ontario, Canada

Site Status

Hamilton, Ontario, Canada

Site Status

Kanata, Ontario, Canada

Site Status

London, Ontario, Canada

Site Status

Newmarket, Ontario, Canada

Site Status

Niagara Falls, Ontario, Canada

Site Status

Oshawa, Ontario, Canada

Site Status

Ottawa, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Pointe-Claire, Quebec, Canada

Site Status

Québec, Quebec, Canada

Site Status

Trois-Rivières, Quebec, Canada

Site Status

Brnho, , Czechia

Site Status

Čáslav, , Czechia

Site Status

České Budějovice, , Czechia

Site Status

Jablonec nad Nisou, , Czechia

Site Status

Kutná Hora, , Czechia

Site Status

Prague, , Czechia

Site Status

Rychnov nad Kněžnou, , Czechia

Site Status

Berlin, , Germany

Site Status

Bonn, , Germany

Site Status

Bramsche, , Germany

Site Status

Cologne, , Germany

Site Status

Hamburg, , Germany

Site Status

Heidelberg, , Germany

Site Status

Mönchengladbach, , Germany

Site Status

München, , Germany

Site Status

Münster, , Germany

Site Status

Neuss, , Germany

Site Status

Osnabrück, , Germany

Site Status

Wesel, , Germany

Site Status

Wiesbaden, , Germany

Site Status

Wuppertal, , Germany

Site Status

Budapest, , Hungary

Site Status

Csorna, , Hungary

Site Status

Pécs, , Hungary

Site Status

Tatabánya, , Hungary

Site Status

Bydgoszcz, , Poland

Site Status

Gdansk, , Poland

Site Status

Katowice, , Poland

Site Status

Krakow, , Poland

Site Status

Lodz, , Poland

Site Status

Lublin, , Poland

Site Status

Poznan, , Poland

Site Status

Rzeszów, , Poland

Site Status

Tarnów, , Poland

Site Status

Warsaw, , Poland

Site Status

Wroclaw, , Poland

Site Status

Zabrze, , Poland

Site Status

Zawadzkie, , Poland

Site Status

Barnaul, , Russia

Site Status

Moscow, , Russia

Site Status

Novosibirsk, , Russia

Site Status

Omsk, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Stavropol, , Russia

Site Status

Tomsk, , Russia

Site Status

Yekaterinburg, , Russia

Site Status

Bardejov, , Slovakia

Site Status

Martin, , Slovakia

Site Status

Poprad, , Slovakia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Canada Czechia Germany Hungary Poland Russia Slovakia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety of Cat-PAD in Cat Allergic Subjects
NCT00685711 COMPLETED PHASE1/PHASE2
Cat-PAD Follow on Study
NCT01272323 COMPLETED