- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620762
Phase III Cat-PAD Study
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium
-
Gent, Belgium
-
Leuven, Belgium
-
-
-
-
Ontario
-
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
-
-
Quebec
-
Montreal, Quebec, Canada
-
Pointe Claire, Quebec, Canada
-
Quebec City, Quebec, Canada
-
Trois Rivieres, Quebec, Canada
-
-
-
-
-
Brnho, Czechia
-
Caslav, Czechia
-
Jablonec nad Nisou, Czechia
-
Kutna Hora, Czechia
-
Prague, Czechia
-
Rychnov nad Kneznou, Czechia
-
České Budějovice, Czechia
-
-
-
-
-
Berlin, Germany
-
Bonn, Germany
-
Bramsche, Germany
-
Hamburg, Germany
-
Heidelberg, Germany
-
Koln, Germany
-
Monchengladbach, Germany
-
Munster, Germany
-
München, Germany
-
Neuss, Germany
-
Osnabruck, Germany
-
Wesel, Germany
-
Wiesbaden, Germany
-
Wuppertal, Germany
-
-
-
-
-
Budapest, Hungary
-
Csorna, Hungary
-
Pecs, Hungary
-
Tatabanya, Hungary
-
-
-
-
-
Bydgoszcz, Poland
-
Gdansk, Poland
-
Katowice, Poland
-
Krakow, Poland
-
Lodz, Poland
-
Lublin, Poland
-
Poznan, Poland
-
Rzeszow, Poland
-
Tarnow, Poland
-
Warszawa, Poland
-
Wroclaw, Poland
-
Zabrze, Poland
-
Zawadzkie, Poland
-
-
-
-
-
Barnaul, Russian Federation
-
Moscow, Russian Federation
-
Novosibirsk, Russian Federation
-
Omsk, Russian Federation
-
Saint-Petersburg, Russian Federation
-
Stavropol, Russian Federation
-
Tomsk, Russian Federation
-
Yekaterinburg, Russian Federation
-
-
-
-
-
Bardejov, Slovakia
-
Martin, Slovakia
-
Poprad, Slovakia
-
-
-
-
California
-
Rolling Hills Estates, California, United States
-
-
Colorado
-
Colorado Springs, Colorado, United States
-
Denver, Colorado, United States
-
Wheat Ridge, Colorado, United States
-
-
Idaho
-
Eagle, Idaho, United States
-
Meridian, Idaho, United States
-
-
Illinois
-
Chicago, Illinois, United States
-
Evanston, Illinois, United States
-
Forrest, Illinois, United States
-
Normal, Illinois, United States
-
-
Iowa
-
Iowa, Iowa, United States
-
-
Kansas
-
Overland Park, Kansas, United States
-
-
Maine
-
Bangor, Maine, United States
-
-
Massachusetts
-
Brockton, Massachusetts, United States
-
-
Michigan
-
Ypsilanti, Michigan, United States
-
-
Minnesota
-
Minneapolis, Minnesota, United States
-
-
Missouri
-
Kansas City, Missouri, United States
-
Saint Louis, Missouri, United States
-
-
Montana
-
Bozeman, Montana, United States
-
Missoula, Montana, United States
-
-
Nebraska
-
Bellevue, Nebraska, United States
-
Fremont, Nebraska, United States
-
Omaha, Nebraska, United States
-
-
New Jersey
-
Ocean Township, New Jersey, United States
-
-
New Mexico
-
Albuquerque, New Mexico, United States
-
-
New York
-
Corning, New York, United States
-
Newburgh, New York, United States
-
-
North Dakota
-
Fargo, North Dakota, United States
-
Minot, North Dakota, United States
-
-
Ohio
-
Canton, Ohio, United States
-
Cincinnati, Ohio, United States
-
Middleburg Heights, Ohio, United States
-
Sylvania, Ohio, United States
-
Toledo, Ohio, United States
-
-
Oklahoma
-
Tulsa, Oklahoma, United States
-
-
Oregon
-
Lake Oswego, Oregon, United States
-
Medford, Oregon, United States
-
Portland, Oregon, United States
-
-
Pennsylvania
-
Blue Bell, Pennsylvania, United States
-
Pittsburgh, Pennsylvania, United States
-
-
Tennessee
-
Germantown, Tennessee, United States
-
Nashville, Tennessee, United States
-
-
Texas
-
Dallas, Texas, United States
-
San Antonio, Texas, United States
-
-
Utah
-
Draper, Utah, United States
-
-
Virginia
-
Glen Allen, Virginia, United States
-
South Burlington, Virginia, United States
-
Warrenton, Virginia, United States
-
-
Washington
-
Spokane, Washington, United States
-
-
Wisconsin
-
Greenfield, Wisconsin, United States
-
Madison, Wisconsin, United States
-
Milwaukee, Wisconsin, United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
1 dose every 4 weeks
|
Experimental: Cat-Pad Treatment 1
Cat-PAD Treatment 1
|
1 dose every 4 weeks
|
Experimental: Cat-PAD Treatment 2
Cat-PAD Treatment regimen 2
|
1 dose every 4 weeks
1 dose every 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo
Time Frame: 52-54 weeks after randomisation
|
The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3. RMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6. |
52-54 weeks after randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean TRSS
Time Frame: 52-54 weeks after randomisation
|
Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo. Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. |
52-54 weeks after randomisation
|
Mean Daily TNSS in Cat-PAD Compared With Placebo
Time Frame: 52-54 weeks after randomisation
|
TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. |
52-54 weeks after randomisation
|
Mean Daily TOSS in Cat-PAD Compared to Placebo
Time Frame: 52-54 weeks after randomisation
|
Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. |
52-54 weeks after randomisation
|
Mean RMS in Cat-PAD Compared With Placebo
Time Frame: 52-54 weeks after randomisation
|
Mean RMS (Rescue medication score) in Cat-PAD treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 52-54 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive. |
52-54 weeks after randomisation
|
Mean RQLQ Score in Cat-PAD Compared With Placebo
Time Frame: 52-54 weeks after randomisation
|
The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (52-54 weeks after randomisation). The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six. |
52-54 weeks after randomisation
|
Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use
Time Frame: 52-54 week after randomisaiton
|
The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 52-54 weeks after randomisation.
|
52-54 week after randomisaiton
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harold Nelson, MD, Jewish National Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rhinoconjunctivitis
-
ALK-Abelló A/SCompletedAllergic RhinoconjunctivitisGermany
-
ClinNovis GmbHCompletedRhinoconjunctivitis, AllergicGermany
-
BioTech Tools S.A.CompletedSeasonal Allergic RhinoconjunctivitisBelgium
-
University of ZurichCompleted
-
Roxall Medicina España S.ACompleted
-
Medical University of GrazRecruiting
-
Immunomic Therapeutics, Inc.Completed
-
University of ZurichCompletedAllergic RhinoconjunctivitisSwitzerland
-
ALK-Abelló A/SCompleted
-
ALK-Abelló A/SCompletedAllergic RhinoconjunctivitisSpain
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States