Cat AllergyNCT01272323
Cat-PAD Follow on Study
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
- What is being tested?
- Cat-PAD Dose 1 and Cat-PAD Dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Apr 2011
- 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: Subject previously randomised in study CP005 and completed all dosing visits and the PTC
Who may be able to join
- Previously randomised in study CP005, completed all treatment visits and the Post Treatment Challenge (PTC).
Who cannot join
- "Partly controlled" and "uncontrolled" asthma
- History of anaphylaxis to cat allergen
- FEV1 of less than 70% of predicted
- Subjects who cannot tolerate baseline challenge in the EEC
- Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs
- A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Optional 1 Year Follow up Study to Evaluate the Continued Efficacy of Cat-PAD 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 approximately one year after the start of treatment.
Read the detailed description
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study CP005 will be invited to attend the Screening Visit for CP005A. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.
- Conditions
- Cat Allergy, Rhinoconjunctivitis
- Being tested
- Placebo, Cat-PAD Dose 1, Cat-PAD Dose 2
- Keywords
- Cat allergy, Rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
Cat-PAD Dose 1Biological
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
Cat-PAD Dose 2Biological
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Subjects previously randomised to receive placebo in study CP005 Receives: Biological: Placebo | |
| Cat-PAD Group 1 | Subjects previously randomised to receive Cat-PAD dose 1 in study CP005 Receives: Biological: Cat-PAD Dose 1 | |
| Cat-PAD Group 2 | Subjects previously randomised to receive Cat-PAD dose 2 in study CP005 Receives: Biological: Cat-PAD Dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Rhinoconjunctivitis Symptom Score
Measured: 50-54 weeks after the start of treatment in CP005
Secondary outcomes (1)
Total Symptom scores for ocular and nasal symptoms
Measured: 50-54 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 posted7 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio, Adiga Life Sciences, Inc.
- Investigators
- Peter Couroux, MD, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272323
- Sponsor's protocol ID
- CP005A
- Status last verified
- May 2011
- First submitted
- 6 Jan 2011
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optional 1 Year Follow up Study to Evaluate the Continued Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT01272323
- Acronym / sponsor ID
- CP005A
- Conditions
- Cat Allergy, Rhinoconjunctivitis
- Keywords
- Cat allergy, Rhinoconjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio, Adiga Life Sciences, Inc.
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Jan 2011 (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 approximately one year after the start of treatment.
Detailed description
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study CP005 will be invited to attend the Screening Visit for CP005A. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | Biological: PlaceboSubjects previously randomised to receive placebo in study CP005 |
| Cat-PAD Group 1 | – | Biological: Cat-PAD Dose 1Subjects previously randomised to receive Cat-PAD dose 1 in study CP005 |
| Cat-PAD Group 2 | – | Biological: Cat-PAD Dose 2Subjects previously randomised to receive Cat-PAD dose 2 in study CP005 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject previously randomised in study CP005 and completed all dosing visits and the PTC
Key inclusion criteria (1 listed)
- Previously randomised in study CP005, completed all treatment visits and the Post Treatment Challenge (PTC).
Key exclusion criteria (6 listed)
- "Partly controlled" and "uncontrolled" asthma
- History of anaphylaxis to cat allergen
- FEV1 of less than 70% of predicted
- Subjects who cannot tolerate baseline challenge in the EEC
- Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboNo further medication to be administered in this study. Intervention refers to treatment received in Study CP005. | Biological | Placebo |
| Cat-PAD Dose 1No further medication to be administered in this study. Intervention refers to treatment received in Study CP005. | Biological | Cat-PAD Group 1 |
| Cat-PAD Dose 2No further medication to be administered in this study. Intervention refers to treatment received in Study CP005. | Biological | Cat-PAD Group 2 |
Primary outcome
Total Rhinoconjunctivitis Symptom Score
Time frame: 50-54 weeks after the start of treatment in CP005
1 secondary outcome
Total Symptom scores for ocular and nasal symptoms
Time frame: 50-54 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 20 May 2011.
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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 20 May 2011. 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: 50-54 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 20 May 2011.