RhinoconjunctivitisPhase 3NCT01620762
Phase III Cat-PAD Study
A Phase 3 study testing Cat-PAD in people with Rhinoconjunctivitis, run by Circassia Limited at 118 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis
- What is being tested?
- Cat-PAD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,408 participants
- Where
- 118 sitesin 9 countries
- Study dates
- Oct 2012to Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
118 sites in 9 countries.
118 sites in 9 countries
United States52 sites
Study site
Albuquerque, New Mexico
Study site
Bangor, Maine
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Bellevue, Nebraska
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Blue Bell, Pennsylvania
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Bozeman, Montana
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Brockton, Massachusetts
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Canton, Ohio
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Chicago, Illinois
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Cincinnati, Ohio
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Colorado Springs, Colorado
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Corning, New York
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Dallas, Texas
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Denver, Colorado
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Draper, Utah
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Eagle, Idaho
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Evanston, Illinois
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Fargo, North Dakota
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Forrest, Illinois
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Fremont, Nebraska
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Germantown, Tennessee
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Glen Allen, Virginia
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Greenfield, Wisconsin
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Iowa City, Iowa
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Kansas City, Missouri
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Lake Oswego, Oregon
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Madison, Wisconsin
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Medford, Oregon
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Meridian, Idaho
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Middleburg Heights, Ohio
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Minot, North Dakota
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Missoula, Montana
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Nashville, Tennessee
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Newburgh, New York
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Normal, Illinois
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Ocean Township, New Jersey
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Omaha, Nebraska
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Overland Park, Kansas
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Pittsburgh, Pennsylvania
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Portland, Oregon
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Rolling Hills Estates, California
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San Antonio, Texas
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South Burlington, Virginia
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Spokane, Washington
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St Louis, Missouri
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Sylvania, Ohio
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Toledo, Ohio
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Tulsa, Oklahoma
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Warrenton, Virginia
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Wheat Ridge, Colorado
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Ypsilanti, Michigan
Canada14 sites
Study site
Burlington, Ontario
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Corruna, Ontario
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Hamilton, Ontario
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Kanata, Ontario
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London, Ontario
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Montreal, Quebec
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Newmarket, Ontario
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Niagara Falls, Ontario
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Oshawa, Ontario
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Ottawa, Ontario
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Pointe-Claire, Quebec
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Québec, Quebec
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Toronto, Ontario
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Trois-Rivières, Quebec
Germany14 sites
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Berlin
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Bonn
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Bramsche
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Cologne
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Hamburg
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Heidelberg
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Mönchengladbach
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München
Study site
Münster
Study site
Neuss
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Osnabrück
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Wesel
Study site
Wiesbaden
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Wuppertal
Poland13 sites
Study site
Bydgoszcz
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Gdansk
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Katowice
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Krakow
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Lodz
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Lublin
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Poznan
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Rzeszów
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Tarnów
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Warsaw
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Wroclaw
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Zabrze
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Zawadzkie
Russia8 sites
Study site
Barnaul
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Moscow
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Novosibirsk
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Omsk
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Saint Petersburg
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Stavropol
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Tomsk
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Yekaterinburg
Czechia7 sites
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Brnho
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Čáslav
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České Budějovice
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Jablonec nad Nisou
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Kutná Hora
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Prague
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Rychnov nad Kněžnou
Hungary4 sites
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Budapest
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Csorna
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Pécs
Study site
Tatabánya
About this 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
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.
- Conditions
- Rhinoconjunctivitis
- Being tested
- Cat-PAD, Placebo
- Keywords
- Cat allergy, Rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cat-PADDrug
1 dose every 4 weeks
PlaceboDrug
1 dose every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cat-Pad Treatment 1 | Experimental | Cat-PAD Treatment 1 Receives: Drug: Cat-PAD |
| Cat-PAD Treatment 2 | Experimental | Cat-PAD Treatment regimen 2 Receives: Drug: Cat-PAD; Drug: Placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo
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.
Measured: 52-54 weeks after randomisation
Secondary outcomes (6)
Mean TRSS
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.
Measured: 52-54 weeks after randomisation
Mean Daily TNSS in Cat-PAD Compared With Placebo
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.
Measured: 52-54 weeks after randomisation
Mean Daily TOSS in Cat-PAD Compared to Placebo
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.
Measured: 52-54 weeks after randomisation
Mean RMS in Cat-PAD Compared With Placebo
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.
Measured: 52-54 weeks after randomisation
Mean RQLQ Score in Cat-PAD Compared With Placebo
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.
Measured: 52-54 weeks after randomisation
Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use
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.
Measured: 52-54 week after randomisaiton
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical, Pharm-Olam International
- Responsible party
- Sponsor
- Investigators
- Harold Nelson, MD, Principal investigator, Jewish National Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620762
- Sponsor's protocol ID
- CP007
- Status last verified
- May 2018
- First submitted
- 30 May 2012
- Last updated
- 15 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01620762
- Acronym / sponsor ID
- CP007
- Conditions
- Rhinoconjunctivitis
- Keywords
- Cat allergy, Rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,408 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical, Pharm-Olam International
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Posted 14 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cat-Pad Treatment 1 | Experimental | Drug: Cat-PADCat-PAD Treatment 1 |
| Cat-PAD Treatment 2 | Experimental | Drug: Cat-PAD, Drug: PlaceboCat-PAD Treatment regimen 2 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cat-PAD1 dose every 4 weeks | Drug | Cat-PAD Treatment 2, Cat-Pad Treatment 1 |
| Placebo1 dose every 4 weeks | Drug | Cat-PAD Treatment 2, Placebo |
Primary outcome
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.
6 secondary outcomes
Mean TRSS
Time frame: 52-54 weeks after randomisation
Mean Daily TNSS in Cat-PAD Compared With Placebo
Time frame: 52-54 weeks after randomisation
Mean Daily TOSS in Cat-PAD Compared to Placebo
Time frame: 52-54 weeks after randomisation
Mean RMS in Cat-PAD Compared With Placebo
Time frame: 52-54 weeks after randomisation
Mean RQLQ Score in Cat-PAD Compared With Placebo
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rhinoconjunctivitis
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Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold Nelson, MD principal investigator
Jewish National Health
118 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cat-PAD in people with Rhinoconjunctivitis, run by Circassia Limited at 118 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 118 sites in United States, Canada, Germany, Poland, Russia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo (time frame: 52-54 weeks after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018; AzTrials last refreshed its copy on 27 Oct 2026.