Phase III Cat-PAD Study
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| ClinicalTrials.gov Identifier: NCT01620762 |
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Recruitment Status :
Completed
First Posted : June 15, 2012
Results First Posted : May 14, 2018
Last Update Posted : June 15, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rhinoconjunctivitis | Drug: Cat-PAD Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | October 2012 |
| Actual Primary Completion Date : | June 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cat-Pad Treatment 1
Cat-PAD Treatment 1
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Drug: Cat-PAD
1 dose every 4 weeks |
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Experimental: Cat-PAD Treatment 2
Cat-PAD Treatment regimen 2
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Drug: Cat-PAD
1 dose every 4 weeks Drug: Placebo 1 dose every 4 weeks |
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo
1 dose every 4 weeks |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult, Older Adult) |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620762
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| Principal Investigator: | Harold Nelson, MD | Jewish National Health |
| Responsible Party: | Circassia Limited |
| ClinicalTrials.gov Identifier: | NCT01620762 |
| Other Study ID Numbers: |
CP007 |
| First Posted: | June 15, 2012 Key Record Dates |
| Results First Posted: | May 14, 2018 |
| Last Update Posted: | June 15, 2018 |
| Last Verified: | May 2018 |
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Cat allergy Rhinoconjunctivitis |
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Conjunctivitis Conjunctival Diseases Eye Diseases |