Phase III Cat-PAD Study

• Sponsor: Circassia Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01620762
• Collaborator: inVentiv Health Clinical (Other), Pharm-Olam International (Industry)
• Enrollment: 1,408
• Locations: 118
• Arms: 3
• Patients Per Site: 11.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinoconjunctivitis	Drug: Cat-PAD; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1408 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cat-Pad Treatment 1 Cat-PAD Treatment 1	Drug: Cat-PAD; 1 dose every 4 weeks
Experimental: Cat-PAD Treatment 2 Cat-PAD Treatment regimen 2	Drug: Cat-PAD; 1 dose every 4 weeks; Drug: Placebo; 1 dose every 4 weeks
Placebo Comparator: Placebo Placebo	Drug: Placebo; 1 dose every 4 weeks

Outcome Measures

Primary Outcome Measures

1. Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo [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.

Secondary Outcome Measures

1. Mean TRSS [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.

2. Mean Daily TNSS in Cat-PAD Compared With Placebo [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.

3. Mean Daily TOSS in Cat-PAD Compared to Placebo [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.

4. Mean RMS in Cat-PAD Compared With Placebo [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.

5. Mean RQLQ Score in Cat-PAD Compared With Placebo [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.

6. Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Rolling Hills Estates	California	United States
2		Colorado Springs	Colorado	United States
3		Denver	Colorado	United States
4		Wheat Ridge	Colorado	United States
5		Eagle	Idaho	United States
6		Meridian	Idaho	United States
7		Chicago	Illinois	United States
8		Evanston	Illinois	United States
9		Forrest	Illinois	United States
10		Normal	Illinois	United States
11		Iowa	Iowa	United States
12		Overland Park	Kansas	United States
13		Bangor	Maine	United States
14		Brockton	Massachusetts	United States
15		Ypsilanti	Michigan	United States
16		Minneapolis	Minnesota	United States
17		Kansas City	Missouri	United States
18		Saint Louis	Missouri	United States
19		Bozeman	Montana	United States
20		Missoula	Montana	United States
21		Bellevue	Nebraska	United States
22		Fremont	Nebraska	United States
23		Omaha	Nebraska	United States
24		Ocean Township	New Jersey	United States
25		Albuquerque	New Mexico	United States
26		Corning	New York	United States
27		Newburgh	New York	United States
28		Fargo	North Dakota	United States
29		Minot	North Dakota	United States
30		Canton	Ohio	United States
31		Cincinnati	Ohio	United States
32		Middleburg Heights	Ohio	United States
33		Sylvania	Ohio	United States
34		Toledo	Ohio	United States
35		Tulsa	Oklahoma	United States
36		Lake Oswego	Oregon	United States
37		Medford	Oregon	United States
38		Portland	Oregon	United States
39		Blue Bell	Pennsylvania	United States
40		Pittsburgh	Pennsylvania	United States
41		Germantown	Tennessee	United States
42		Nashville	Tennessee	United States
43		Dallas	Texas	United States
44		San Antonio	Texas	United States
45		Draper	Utah	United States
46		Glen Allen	Virginia	United States
47		South Burlington	Virginia	United States
48		Warrenton	Virginia	United States
49		Spokane	Washington	United States
50		Greenfield	Wisconsin	United States
51		Madison	Wisconsin	United States
52		Milwaukee	Wisconsin	United States
53		Brussels		Belgium
54		Gent		Belgium
55		Leuven		Belgium
56		Burlington	Ontario	Canada
57		Corruna	Ontario	Canada
58		Hamilton	Ontario	Canada
59		Kanata	Ontario	Canada
60		London	Ontario	Canada
61		Newmarket	Ontario	Canada
62		Niagara Falls	Ontario	Canada
63		Oshawa	Ontario	Canada
64		Ottawa	Ontario	Canada
65		Toronto	Ontario	Canada
66		Montreal	Quebec	Canada
67		Pointe Claire	Quebec	Canada
68		Quebec City	Quebec	Canada
69		Trois Rivieres	Quebec	Canada
70		Brnho		Czechia
71		Caslav		Czechia
72		Jablonec nad Nisou		Czechia
73		Kutna Hora		Czechia
74		Prague		Czechia
75		Rychnov nad Kneznou		Czechia
76		České Budějovice		Czechia
77		Berlin		Germany
78		Bonn		Germany
79		Bramsche		Germany
80		Hamburg		Germany
81		Heidelberg		Germany
82		Koln		Germany
83		Monchengladbach		Germany
84		Munster		Germany
85		München		Germany
86		Neuss		Germany
87		Osnabruck		Germany
88		Wesel		Germany
89		Wiesbaden		Germany
90		Wuppertal		Germany
91		Budapest		Hungary
92		Csorna		Hungary
93		Pecs		Hungary
94		Tatabanya		Hungary
95		Bydgoszcz		Poland
96		Gdansk		Poland
97		Katowice		Poland
98		Krakow		Poland
99		Lodz		Poland
100		Lublin		Poland
101		Poznan		Poland
102		Rzeszow		Poland
103		Tarnow		Poland
104		Warszawa		Poland
105		Wroclaw		Poland
106		Zabrze		Poland
107		Zawadzkie		Poland
108		Barnaul		Russian Federation
109		Moscow		Russian Federation
110		Novosibirsk		Russian Federation
111		Omsk		Russian Federation
112		Saint-Petersburg		Russian Federation
113		Stavropol		Russian Federation
114		Tomsk		Russian Federation
115		Yekaterinburg		Russian Federation
116		Bardejov		Slovakia
117		Martin		Slovakia
118		Poprad		Slovakia

Sponsors and Collaborators

• Circassia Limited
• inVentiv Health Clinical
• Pharm-Olam International

Investigators

• Principal Investigator: Harold Nelson, MD, Jewish National Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Circassia Limited
• ClinicalTrials.gov Identifier: NCT01620762
• Other Study ID Numbers: CP007
• First Posted: Jun 15, 2012
• Last Update Posted: Jun 15, 2018
• Last Verified: May 1, 2018

• Keywords provided by Circassia Limited: Cat allergy; Rhinoconjunctivitis
• Additional relevant MeSH terms: Conjunctivitis

Study Results

Participant Flow

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks
Period Title: Overall Study
STARTED	468	470	470
COMPLETED	420	412	417
NOT COMPLETED	48	58	53

Baseline Characteristics

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo	Total
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks	Total of all reporting groups
Overall Participants	468	470	470	1408
Age (Count of Participants)
<=18 years	29 6.2%	29 6.2%	32 6.8%	90 6.4%
Between 18 and 65 years	439 93.8%	441 93.8%	438 93.2%	1318 93.6%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	301 64.3%	317 67.4%	317 67.4%	935 66.4%
Male	167 35.7%	153 32.6%	153 32.6%	473 33.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 1.7%	1 0.2%	2 0.4%	11 0.8%
Not Hispanic or Latino	458 97.9%	468 99.6%	463 98.5%	1389 98.7%
Unknown or Not Reported	2 0.4%	1 0.2%	5 1.1%	8 0.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks
Measure Participants	417	414	414
Least Squares Mean (Standard Error) [units on a scale]	1.04 (0.068)	1.00 (0.068)	1.05 (0.068)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks
Measure Participants	417	414	414
Least Squares Mean (Standard Error) [units on a scale]	5.67 (0.358)	5.54 (0.356)	5.87 (0.357)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks
Measure Participants	417	414	414
Least Squares Mean (Standard Error) [units on a scale]	3.48 (0.197)	3.36 (0.196)	3.44 (0.196)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks
Measure Participants	417	414	414
Least Squares Mean (Standard Error) [units on a scale]	2.20 (0.179)	2.19 (0.178)	2.42 (0.179)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks
Measure Participants	417	414	414
Least Squares Mean (Standard Error) [units on a scale]	0.34 (0.038)	0.31 (0.037)	0.32 (0.037)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks
Measure Participants	396	403	393
Least Squares Mean (Standard Error) [units on a scale]	1.26 (0.080)	1.26 (0.079)	1.25 (0.079)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Arm/Group Title	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment 2 (2 Courses)	Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo: 1 dose every 4 weeks
Measure Participants	417	414	414
Least Squares Mean (Standard Error) [days]	9.44 (0.56)	10.11 (0.556)	9.76 (0.557)

Adverse Events

Time Frame	Up to 52 weeks after randomisation
Adverse Event Reporting Description	The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Arm/Group Title	Cat-PAD Treatment 1 (1 Course)		Cat-PAD Treatment 2 (2 Courses)		Placebo
Arm/Group Description	Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks		Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks		Placebo Placebo: 1 dose every 4 weeks
All Cause Mortality
	Cat-PAD Treatment 1 (1 Course)		Cat-PAD Treatment 2 (2 Courses)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cat-PAD Treatment 1 (1 Course)		Cat-PAD Treatment 2 (2 Courses)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/467 (2.4%)		13/470 (2.8%)		9/470 (1.9%)
Cardiac disorders
Myocardial infarction	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Endocrine disorders
Hypthyroidism	0/467 (0%)	0	0/470 (0%)	0	1/470 (0.2%)	1
Gastrointestinal disorders
Vomiting	0/467 (0%)	0	0/470 (0%)	0	1/470 (0.2%)	1
Immune system disorders
Hypersensitivity	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Infections and infestations
Acarodermatitis	0/467 (0%)	0	0/470 (0%)	0	1/470 (0.2%)	1
Pyelonephritis	0/467 (0%)	0	0/470 (0%)	0	1/470 (0.2%)	1
Appendicitis	1/467 (0.2%)	1	1/470 (0.2%)	1	0/470 (0%)	0
Diverticulitis	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Scrotal abscess	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Infectious mononucleosis	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Upper respiratory tract infection	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Cellulitis	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Injury, poisoning and procedural complications
Rib fracture	0/467 (0%)	0	0/470 (0%)	0	1/470 (0.2%)	1
Skull fracture	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Procedural pain	2/467 (0.4%)	2	0/470 (0%)	0	0/470 (0%)	0
Comminuted fracture	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Post procedural haemorrhage	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Hand fracture	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/467 (0%)	0	0/470 (0%)	0	1/470 (0.2%)	1
Femoroacetabular impingement	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma	0/467 (0%)	0	0/470 (0%)	0	1/470 (0.2%)	1
Benign breast neoplasm	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Invasive ductal breast carcinoma	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Nervous system disorders
Vascular headache	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Psychiatric disorders
Major depression	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Suicidal ideation	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Renal and urinary disorders
Hydonephrosis	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
IgA nephropathy	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	1/467 (0.2%)	1	0/470 (0%)	0	1/470 (0.2%)	1
Pneumothorax spontaneous	0/467 (0%)	0	0/470 (0%)	0	1/470 (0.2%)	1
Haemoptysis	1/467 (0.2%)	1	0/470 (0%)	0	0/470 (0%)	0
Pulmonary embolism	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Vascular disorders
Deep Vein Thrombosis	0/467 (0%)	0	1/470 (0.2%)	1	0/470 (0%)	0
Other (Not Including Serious) Adverse Events
	Cat-PAD Treatment 1 (1 Course)		Cat-PAD Treatment 2 (2 Courses)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	298/467 (63.8%)		299/470 (63.6%)		305/470 (64.9%)
Gastrointestinal disorders
Nausea	9/467 (1.9%)	10	12/470 (2.6%)	12	3/470 (0.6%)	3
Diarrhoea	5/467 (1.1%)	6	6/470 (1.3%)	7	12/470 (2.6%)	15
Toothache	1/467 (0.2%)	1	11/470 (2.3%)	12	5/470 (1.1%)	5
General disorders
Injection site pruritus	19/467 (4.1%)	51	13/470 (2.8%)	45	11/470 (2.3%)	41
Injection site urticaria	17/467 (3.6%)	95	9/470 (1.9%)	43	7/470 (1.5%)	41
Pyrexia	6/467 (1.3%)	6	12/470 (2.6%)	13	6/470 (1.3%)	7
Immune system disorders
Allergy to animal	9/467 (1.9%)	9	9/470 (1.9%)	11	11/470 (2.3%)	13
Infections and infestations
Nasopharyngitis	85/467 (18.2%)	124	87/470 (18.5%)	128	90/470 (19.1%)	127
Upper respiratory tract infection	37/467 (7.9%)	48	34/470 (7.2%)	41	42/470 (8.9%)	60
Sinusitis	21/467 (4.5%)	26	24/470 (5.1%)	29	23/470 (4.9%)	24
Bronchitis	23/467 (4.9%)	27	23/470 (4.9%)	25	19/470 (4%)	21
Pharyngitis	11/467 (2.4%)	11	18/470 (3.8%)	20	14/470 (3%)	17
Influenza	9/467 (1.9%)	9	5/470 (1.1%)	5	19/470 (4%)	20
Urinary tract infection	9/467 (1.9%)	11	12/470 (2.6%)	16	11/470 (2.3%)	13
Tonsillitis	9/467 (1.9%)	11	10/470 (2.1%)	12	7/470 (1.5%)	7
Rhinitis	8/467 (1.7%)	8	4/470 (0.9%)	5	10/470 (2.1%)	13
Musculoskeletal and connective tissue disorders
Back pain	12/467 (2.6%)	20	9/470 (1.9%)	12	15/470 (3.2%)	20
Athralgia	7/467 (1.5%)	8	12/470 (2.6%)	16	16/470 (3.4%)	16
Nervous system disorders
Headache	25/467 (5.4%)	78	39/470 (8.3%)	86	35/470 (7.4%)	76
Respiratory, thoracic and mediastinal disorders
Cough	18/467 (3.9%)	26	18/470 (3.8%)	27	24/470 (5.1%)	26
Orophayngeal pai	16/467 (3.4%)	20	16/470 (3.4%)	20	16/470 (3.4%)	18
Athma	17/467 (3.6%)	21	14/470 (3%)	15	16/470 (3.4%)	17
Dyspnoea	12/467 (2.6%)	19	7/470 (1.5%)	13	11/470 (2.3%)	12

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

To avoid disclosures that may affect the proprietary rights of the Sponsor, the Investigator agrees to allow Circassia the opportunity to review all manuscripts and abstracts 60 days prior to submission for publication. Circassia reserves the right to include the report of this study in any regulatory documentation or submission or in any informational materials.