Cat AllergyPhase 2NCT01033344
Cat-PAD Exposure Chamber Study
A Phase 2 study testing Cat-PAD in people with Cat Allergy, 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. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cat Allergy
- What is being tested?
- Cat-PAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Sep 2010
- Phase
- Phase 2
- 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
Who may be able to join
- Male or female, aged 18-65 years
- Minimum 1-year history of rhinoconjunctivitis on exposure to cats. (Subjects may also have controlled asthma)
- Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control
- Minimum qualifying rhinoconjunctivitis symptom scores
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: A Double-blind, Randomized, Placebo-controlled Study to Evaluate Two Treatment Regimens 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. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy.
This study will look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.
Read the detailed description
This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.
In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.
In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.
- Conditions
- Cat Allergy
- Being tested
- Placebo, Cat-PAD
- Keywords
- Cat allergy, Rhinoconjunctivitis, Exposure chamber, Immunotherapy, Cat-PAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Intradermal injection 1x8 administrations 2 weeks apart
Cat-PADBiological
Intradermal injection 1x8 administrations 2 weeks apart
Cat-PADBiological
Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Solution resembling active solution but without peptides Receives: Biological: Placebo |
| Group 1 | Experimental | Cat-PAD dose group 1 Receives: Biological: Cat-PAD |
| Group 2 | Experimental | Cat-PAD Dose group 2 Receives: Biological: Cat-PAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Rhinoconjunctivitis Symptom Score
Measured: 0 and 18-22 weeks after start of treatment
Secondary outcomes (4)
Symptom scores for ocular and nasal symptoms
Measured: 0 and 18-22 weeks after start of treatment
Acoustic Rhinometry
Measured: 0 and 18-22 weeks after start of treatment
Cat Specific IgE
Measured: At 0 weeks and at follow up
Adverse Events
Measured: During study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Cetero Research, San Antonio
- Investigators
- Deepen Patel, MD, CCF, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033344
- Sponsor's protocol ID
- CP005
- Status last verified
- Sep 2010
- First submitted
- 15 Dec 2009
- Last updated
- 1 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate Two Treatment Regimens of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT01033344
- Acronym / sponsor ID
- CP005
- Conditions
- Cat Allergy
- Keywords
- Cat allergy, Rhinoconjunctivitis, Exposure chamber, Immunotherapy, Cat-PAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Cetero Research, San Antonio
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Dec 2009 (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. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy.
This study will look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.
Detailed description
This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.
In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.
In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.
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 |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboSolution resembling active solution but without peptides |
| Group 1 | Experimental | Biological: Cat-PADCat-PAD dose group 1 |
| Group 2 | Experimental | Biological: Cat-PADCat-PAD Dose group 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18-65 years
- Minimum 1-year history of rhinoconjunctivitis on exposure to cats. (Subjects may also have controlled asthma)
- Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control
- Minimum qualifying rhinoconjunctivitis symptom scores
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 |
|---|---|---|
| PlaceboIntradermal injection 1x8 administrations 2 weeks apart | Biological | Placebo |
| Cat-PADIntradermal injection 1x8 administrations 2 weeks apart | Biological | Group 1 |
| Cat-PADIntradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo | Biological | Group 2 |
Primary outcome
Total Rhinoconjunctivitis Symptom Score
Time frame: 0 and 18-22 weeks after start of treatment
4 secondary outcomes
Symptom scores for ocular and nasal symptoms
Time frame: 0 and 18-22 weeks after start of treatment
Acoustic Rhinometry
Time frame: 0 and 18-22 weeks after start of treatment
Cat Specific IgE
Time frame: At 0 weeks and at follow up
Adverse Events
Time frame: During study
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 1 Oct 2010.
Related trials for Cat Allergy
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Asthma, Allergic Rhinitis
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.
Deepen Patel, MD, CCF 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?
A Phase 2 study testing Cat-PAD in people with Cat Allergy, 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 4 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 1 Oct 2010. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 0 and 18-22 weeks after start of treatment). 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 1 Oct 2010; AzTrials last refreshed its copy on 27 Oct 2026.