Cat AllergyPhase 3NCT02040844
Phase III Cat-PAD Follow-on Study
A Phase 3 study testing Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762], Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762] and Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762] in people with Cat Allergy, run by Circassia Limited.
Trial summary
The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cat Allergy
- What is being tested?
- Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762], Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762] and Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- previously completed clinical study CP007 [NCT01620762]
Who cannot join
- started allergen therapy since completing CP007
- Institutionalised due to a legal or regulatory order
About this study
Official title: An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years After the Administration of Treatment
The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.
- Conditions
- Cat Allergy
- Being tested
- Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762], Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762], Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]Drug
Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]Drug
Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]Drug
| Study group | Role | What they receive |
|---|---|---|
| Cat-PAD Treatment 1 | Other | Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762].No further treatment received in CP007A Receives: Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762] |
| Cat-PAD Treatment 2 | Other | Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762].No further treatment received in CP007A. Receives: Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762] |
| Cat-PAD Treatment 3 | Other | Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]. No further treatment received in CP007A. Receives: Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])
The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007).
CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). 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 TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3.
AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6.
Measured: 1 year after completing CP007
Secondary outcomes (5)
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 one year after completing the first study (CP007).
Measured: 1 year after completion of CP007
Mean Component Scores of the TRSS (Nasal)
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 1 year after completing the original CP007 study.
Measured: 1 year after completion of CP007
Mean Component Scores of the TRSS (Ocular)
Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups
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. 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 one year after completing the original CP007 study
Measured: 1 year after completion of CP007
Mean Allergy Medication Score (AMS)
Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups.
The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use 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: 1 year after completion of CP007
Mean RQLQ Score
The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007).
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.
A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome.
Measured: 1 year after completion of CP007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2017
- Study completionMay 2017
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 Cat AllergyStudies 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
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörg Kleine-Tebbe, MD, Principal investigator, Clinical Research Center for Dermatology, Allergy & Asthma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040844
- Sponsor's protocol ID
- CP007 A
- Status last verified
- May 2018
- First submitted
- 17 Jan 2014
- Last updated
- 15 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years After the Administration of Treatment
- ClinicalTrials.gov ID
- NCT02040844
- Acronym / sponsor ID
- CP007 A
- Conditions
- Cat Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 Jan 2014 (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 evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.
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 | Other | Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762].No further treatment received in CP007A |
| Cat-PAD Treatment 2 | Other | Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762].No further treatment received in CP007A. |
| Cat-PAD Treatment 3 | Other | Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]. No further treatment received in CP007A. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- previously completed clinical study CP007 [NCT01620762]
Key exclusion criteria (2 listed)
- started allergen therapy since completing CP007
- Institutionalised due to a legal or regulatory order
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 |
|---|---|---|
| Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762] | Drug | Cat-PAD Treatment 1 |
| Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762] | Drug | Cat-PAD Treatment 2 |
| Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762] | Drug | Cat-PAD Treatment 3 |
Primary outcome
Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])
Time frame: 1 year after completing CP007
The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007). CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). 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 TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3. AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6.
5 secondary outcomes
Mean TRSS
Time frame: 1 year after completion of CP007
Mean Component Scores of the TRSS (Nasal)
Time frame: 1 year after completion of CP007
Mean Component Scores of the TRSS (Ocular)
Time frame: 1 year after completion of CP007
Mean Allergy Medication Score (AMS)
Time frame: 1 year after completion of CP007
Mean RQLQ Score
Time frame: 1 year after completion of CP007
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.
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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.
Jörg Kleine-Tebbe, MD principal investigator
Clinical Research Center for Dermatology, Allergy & Asthma
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762], Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762] and Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762] in people with Cat Allergy, run by Circassia Limited.
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 1 inclusion and 2 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 (CS) Consisting of TRSS/8+Allergy Medication Score[AMS]) (time frame: 1 year after completing CP007). 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.