Cat AllergyNCT01604018
An Optional Two Year Follow Up Study to Study CP005A
An observational study of Cat Allergy and Rhinoconjunctivitis, run by Circassia Limited at 1 site in Canada.
Trial summary
Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cat Allergy, Rhinoconjunctivitis
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects previously randomised in study CP005 and completed all dosing and PTC in CP005 and all visits in CP005A.
Who may be able to join
- Previously randomised into study CP005 and completed all visits in the follow-on study CP005A
Who cannot join
- "Partly controlled" and "uncontrolled" asthma
- History of anaphylaxis to cat allergen
- Subjects with an FEV1 < 70% of predicted
- Subjects who cannot tolerate baseline challenge in the EEC
- Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
- Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber
Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.
The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.
Read the detailed description
Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.
- Conditions
- Cat Allergy, Rhinoconjunctivitis
- Keywords
- Cat Allergy, Rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Subjects previously randomized to receive placebo in study CP005 and completed CP005A. | |
| Cat-PAD Group 1 | Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A. | |
| Cat-Pad Group 2 | Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Rhinoconjunctivitis Symptom Score
Measured: 102-106 weeks after the start of treatment in CP005
Secondary outcomes (1)
Total Symptom scores for ocular and nasal symptoms
Measured: 102-106 weeks after the start of treatment in CP005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Cetero Research, Toronto
- Responsible party
- Sponsor
- Investigators
- Peter Couroux, MD, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604018
- Sponsor's protocol ID
- CP005B
- Status last verified
- May 2012
- First submitted
- 21 May 2012
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT01604018
- Acronym / sponsor ID
- CP005B
- Conditions
- Cat Allergy, Rhinoconjunctivitis
- Keywords
- Cat Allergy, Rhinoconjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Cetero Research, Toronto
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.
The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.
Detailed description
Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | –Subjects previously randomized to receive placebo in study CP005 and completed CP005A. |
| Cat-PAD Group 1 | – | –Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A. |
| Cat-Pad Group 2 | – | –Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects previously randomised in study CP005 and completed all dosing and PTC in CP005 and all visits in CP005A.
Key inclusion criteria (1 listed)
- Previously randomised into study CP005 and completed all visits in the follow-on study CP005A
Key exclusion criteria (6 listed)
- "Partly controlled" and "uncontrolled" asthma
- History of anaphylaxis to cat allergen
- Subjects with an FEV1 < 70% of predicted
- Subjects who cannot tolerate baseline challenge in the EEC
- Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Rhinoconjunctivitis Symptom Score
Time frame: 102-106 weeks after the start of treatment in CP005
1 secondary outcome
Total Symptom scores for ocular and nasal symptoms
Time frame: 102-106 weeks after the start of treatment in CP005
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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.
Peter Couroux, MD principal investigator
Cetero Research, San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cat Allergy and Rhinoconjunctivitis, run by Circassia Limited at 1 site in Canada.
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 6 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 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Rhinoconjunctivitis Symptom Score (time frame: 102-106 weeks after the start of treatment in CP005). 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 24 May 2012.