Phase III Cat-PAD Study
Primary Purpose
Rhinoconjunctivitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cat-PAD
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring Cat allergy, Rhinoconjunctivitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Cat-Pad Treatment 1
Cat-PAD Treatment 2
Placebo
Arm Description
Cat-PAD Treatment 1
Cat-PAD Treatment regimen 2
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01620762
First Posted
May 30, 2012
Last Updated
May 16, 2018
Sponsor
Circassia Limited
Collaborators
inVentiv Health Clinical, Pharm-Olam International
1. Study Identification
Unique Protocol Identification Number
NCT01620762
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
Collaborators
inVentiv Health Clinical, Pharm-Olam International
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis
Keywords
Cat allergy, Rhinoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cat-Pad Treatment 1
Arm Type
Experimental
Arm Description
Cat-PAD Treatment 1
Arm Title
Cat-PAD Treatment 2
Arm Type
Experimental
Arm Description
Cat-PAD Treatment regimen 2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Cat-PAD
Intervention Description
1 dose every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 dose every 4 weeks
Primary Outcome Measure Information:
Title
Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo
Description
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.
Time Frame
52-54 weeks after randomisation
Secondary Outcome Measure Information:
Title
Mean TRSS
Description
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.
Time Frame
52-54 weeks after randomisation
Title
Mean Daily TNSS in Cat-PAD Compared With Placebo
Description
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.
Time Frame
52-54 weeks after randomisation
Title
Mean Daily TOSS in Cat-PAD Compared to Placebo
Description
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.
Time Frame
52-54 weeks after randomisation
Title
Mean RMS in Cat-PAD Compared With Placebo
Description
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.
Time Frame
52-54 weeks after randomisation
Title
Mean RQLQ Score in Cat-PAD Compared With Placebo
Description
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.
Time Frame
52-54 weeks after randomisation
Title
Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use
Description
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.
Time Frame
52-54 week after randomisaiton
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold Nelson, MD
Organizational Affiliation
Jewish National Health
Official's Role
Principal Investigator
Facility Information:
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Rolling Hills Estates
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California
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Colorado Springs
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Denver
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Toledo
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Lake Oswego
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South Burlington
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Gent
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Corruna
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Hamilton
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Kanata
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London
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Newmarket
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Niagara Falls
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Oshawa
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Toronto
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Montreal
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Pointe Claire
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Quebec City
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Quebec
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Trois Rivieres
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Brnho
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Czechia
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Caslav
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Czechia
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Jablonec nad Nisou
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Czechia
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Kutna Hora
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Czechia
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Prague
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Czechia
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Rychnov nad Kneznou
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České Budějovice
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Czechia
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Berlin
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Germany
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Bonn
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Germany
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Bramsche
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Koln
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Germany
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Monchengladbach
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Germany
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Munster
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Germany
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München
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Germany
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Neuss
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Germany
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Osnabruck
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Germany
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Wesel
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Germany
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Wiesbaden
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Germany
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Wuppertal
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Germany
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Budapest
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Hungary
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Csorna
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Hungary
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Pecs
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Hungary
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Tatabanya
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Hungary
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Bydgoszcz
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Poland
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Gdansk
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Poland
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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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Rzeszow
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Tarnow
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Warszawa
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Wroclaw
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Zabrze
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Poland
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Zawadzkie
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Poland
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Barnaul
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Stavropol
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Russian Federation
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Tomsk
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Russian Federation
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Yekaterinburg
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Russian Federation
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Bardejov
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Slovakia
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Martin
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Slovakia
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Poprad
Country
Slovakia
12. IPD Sharing Statement
Learn more about this trial
Phase III Cat-PAD Study
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