Phase III Cat-PAD Study
- Registration Number
- NCT01620762
- Lead Sponsor
- Circassia Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1408
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cat-Pad Treatment 1 Cat-PAD Cat-PAD Treatment 1 Cat-PAD Treatment 2 Cat-PAD Cat-PAD Treatment regimen 2 Cat-PAD Treatment 2 Placebo Cat-PAD Treatment regimen 2 Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.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.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.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.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.
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.