Clinical trial NCT01620762: Phase III Cat-PAD Study
Official title: A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinoconjunctivitis
Keywords: Cat allergy
Rhinoconjunctivitis
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: inVentiv Health Clinical
name: Pharm-Olam International
First posted: 2012-06-15
Enrollment: 1408
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo
timeFrame: 52-54 weeks after randomisation
Secondary outcomes:
measure: Mean TRSS
timeFrame: 52-54 weeks after randomisation
measure: Mean Daily TNSS in Cat-PAD Compared With Placebo
timeFrame: 52-54 weeks after randomisation
measure: Mean Daily TOSS in Cat-PAD Compared to Placebo
timeFrame: 52-54 weeks after randomisation
measure: Mean RMS in Cat-PAD Compared With Placebo
timeFrame: 52-54 weeks after randomisation
measure: Mean RQLQ Score in Cat-PAD Compared With Placebo
timeFrame: 52-54 weeks after randomisation
measure: Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use
timeFrame: 52-54 week after randomisaiton
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Eagle
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Forrest
country: United States
state: Illinois
city: Normal
country: United States
state: Illinois
city: Iowa
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Bangor
country: United States
state: Maine
city: Brockton
country: United States
state: Massachusetts
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Bozeman
country: United States
state: Montana
city: Missoula
country: United States
state: Montana
city: Bellevue
country: United States
state: Nebraska
city: Fremont
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Ocean Township
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Corning
country: United States
state: New York
city: Newburgh
country: United States
state: New York
city: Fargo
country: United States
state: North Dakota
city: Minot
country: United States
state: North Dakota
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Sylvania
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Lake Oswego
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Blue Bell
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Draper
country: United States
state: Utah
city: Glen Allen
country: United States
state: Virginia
city: South Burlington
country: United States
state: Virginia
city: Warrenton
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Greenfield
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Burlington
country: Canada
state: Ontario
city: Corruna
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Kanata
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Niagara Falls
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Pointe Claire
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Trois Rivieres
country: Canada
state: Quebec
city: Brnho
country: Czechia
city: Caslav
country: Czechia
city: Jablonec nad Nisou
country: Czechia
city: Kutna Hora
country: Czechia
city: Prague
country: Czechia
city: Rychnov nad Kneznou
country: Czechia
city: České Budějovice
country: Czechia
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Bramsche
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Koln
country: Germany
city: Monchengladbach
country: Germany
city: Munster
country: Germany
city: München
country: Germany
city: Neuss
country: Germany
city: Osnabruck
country: Germany
city: Wesel
country: Germany
city: Wiesbaden
country: Germany
city: Wuppertal
country: Germany
city: Budapest
country: Hungary
city: Csorna
country: Hungary
city: Pecs
country: Hungary
city: Tatabanya
country: Hungary
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Rzeszow
country: Poland
city: Tarnow
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
city: Zawadzkie
country: Poland
city: Barnaul
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Yekaterinburg
country: Russian Federation
city: Bardejov
country: Slovakia
city: Martin
country: Slovakia
city: Poprad
country: Slovakia
Study officials:
affiliation: Jewish National Health
name: Harold Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References: