Cat AllergyPhase 2NCT00867906
Safety of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects With Controlled Asthma
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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Apr 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.
- A history of controlled asthma as defined in GINA (2007) on exposure to cats for at least 1 year
- Asthma controlled with:Inhaled salbutamol (Cohort 1), Inhaled corticosteroid (Cohort 2), Inhaled corticosteroid plus a long acting β2agonist (LABA) (Cohort 3) Treatment for asthma must have been stable (drug(s), dose, frequency) for at least 3 months.
- A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) on exposure to cats for at least 1 year.
- Subjects who provide written informed consent.
- Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
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- A LPSR to cat allergen eight hours after intradermal injection of greater than 25mm diameter.
- Positive CPT with a score ≥4.
- The subject must be willing and able to comply with the study requirements.
- If the subject is female and of childbearing potential she must practice an acceptable form of contraception, and produce a negative urine pregnancy test on the Screening Visit. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal.
Who cannot join
- Subjects with asthma falling under GINA (2007) definitions "partly controlled" and "uncontrolled"
- Subjects with a requirement for more than 1000 µg beclomethasone (or equivalent) per day for the treatment of asthma.
- A history of anaphylaxis to cat allergen.
- Subjects with a cat specific IgE >100 kU/L.
- Subjects with an FEV1 <80% of normal
- Subjects with an acute phase skin response to cat allergen with a wheal diameter > 30mm.
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- Subjects who suffer from seasonal allergic rhinoconjunctivitis, and cannot complete the baseline/post-treatment challenge (PTC) and the dosing periods outside the respective pollen season.
- Allergen immunotherapy during the last 12 months or any history of Cat Dander immunotherapy.
- Subjects who have completed or are undergoing ongoing treatment with anti-IgE-antibody.
- Use of the therapies listed in Section 5.9.2 at any time during the study will make the subject ineligible for the study.
- The subject has unacceptable symptoms in the 3 days without loratadine prior to the screening visit.
- Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- Subjects being treated with beta-blockers.
- Have symptoms of a clinically relevant illness in the Investigator's opinion, within 6 weeks prior to Screening Visit.
- Female subjects who are pregnant, lactating or planning a pregnancy during the study.
- Have any clinically relevant abnormalities detected on physical examination.
- 12-lead ECG or vital signs (blood pressure, pulse rate, respiratory rate and oral temperature) that are outside normal limits, unless the abnormality is considered not to be of clinical relevance by the Investigator.
- Laboratory values (haematology, biochemistry, urine tests) that are outside the normal ranges, unless the abnormality is considered not to be of clinical relevance by the Investigator.
- Significant history of alcohol or drug abuse.
- History of immunopathological diseases.
- Positive test for hepatitis B, hepatitis C or HIV at screening.
- Previously randomised into this study or have received Cat-PAD (or a prototype thereof) previously.
- Have a history of severe drug allergy or anaphylactic reaction to food.
- Planned travel outside the study area for a substantial portion of the study period.
- Have received treatment with an investigational drug within 6 months prior to study screening or have participated in a study with a new formulation of a marketed drug one month prior to study screening.
- Are unable to communicate or to understand the requirements of the study, or any psychiatric disorder, which would impair communication between the subject and the Investigator thereby interfering with the informed consent procedure or the gathering of study data.
- A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.
- Subjects with a known allergy to thioglycerol.
- Subjects who have a dependent relationship (e.g. employees or family members) with either the Sponsor or Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety of Cat-PAD in Cat Allergic Subjects With Controlled Asthma
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 evaluate the safety and tolerability of multiple doses of Cat-PAD in controlled asthmatics treated with either inhaled salbutamol, inhaled corticosteroids or inhaled corticosteroids with a LABA and to explore the efficacy of Cat-PAD in these subjects using the Late Phase Skin Response, Early Phase Skin Response, and Conjunctival Provocation Test.
Read the detailed description
This study is designed as a randomised, double-blind, placebo-controlled, parallel group, multiple dose study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis and controlled asthma. The efficacy of Cat-PAD will also be explored in these subjects using the EPSR, LPSR, CPT, and levels of cat specific IgE. A single centre will be initiated first, with a second centre included as a backup, if needed, to enable recruitment numbers to be met.
Three cohorts will be studied, depending on the treatment used to control the subject's asthma:Cohort 1 - inhaled salbutamol only, Cohort 2 - inhaled corticosteroid only, Cohort 3 - inhaled corticosteroid plus a LABA
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic, at the investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4 weeks before randomisation.
In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to either 3 nmol Cat-PAD or placebo. Treatments will be administered every 2 weeks (±2 days) for 14 week
In Period 3, Post Treatment Challenge consist of a single visit 24-28 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
- Cat-PAD, Placebo
- Keywords
- Cat allergy, Immunotherapy, Cat-PAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cat-PADBiological
Cat-PAD dose 1x8 administrations 2 weeks apart
PlaceboBiological
Placebo comparator, 1x8 administrations 2 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Asthmatics using salbutamol only, subjects to receive either Cat-PAD or placebo comparator Receives: Biological: Cat-PAD; Biological: Placebo |
| Cohort 2 | Other | Asthmatics using inhaled corticosteroid, subjects to receive either Cat-PAD or placebo comparator Receives: Biological: Cat-PAD; Biological: Placebo |
| Cohort 3 | Other | Asthmatics using inhaled corticosteroid and LABA, subjects to receive either Cat-PAD or placebo comparator Receives: Biological: Cat-PAD; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of multiple intradermal injections of Cat-PAD in cat allergic subjects with controlled asthma
Measured: 28 weeks
Secondary outcomes (4)
Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo
Measured: 28 weeks
Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo
Measured: 28 weeks
Mean change from baseline in CPT score at PTC after Cat-PAD injection compared to placebo
Measured: 28 weeks
Mean change from baseline in concentration of cat specific IgE at PTC after Cat-PAD injection compared to placebo
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2010
- Study completionApr 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Investigators
- Amarjit Cheema, MD, Principal investigator, Alpha Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867906
- Sponsor's protocol ID
- CP003
- Status last verified
- May 2010
- First submitted
- 19 Mar 2009
- Last updated
- 6 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety of Cat-PAD in Cat Allergic Subjects With Controlled Asthma
- ClinicalTrials.gov ID
- NCT00867906
- Acronym / sponsor ID
- CP003
- Conditions
- Cat Allergy
- Keywords
- Cat allergy, Immunotherapy, Cat-PAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 24 Mar 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 evaluate the safety and tolerability of multiple doses of Cat-PAD in controlled asthmatics treated with either inhaled salbutamol, inhaled corticosteroids or inhaled corticosteroids with a LABA and to explore the efficacy of Cat-PAD in these subjects using the Late Phase Skin Response, Early Phase Skin Response, and Conjunctival Provocation Test.
Detailed description
This study is designed as a randomised, double-blind, placebo-controlled, parallel group, multiple dose study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis and controlled asthma. The efficacy of Cat-PAD will also be explored in these subjects using the EPSR, LPSR, CPT, and levels of cat specific IgE. A single centre will be initiated first, with a second centre included as a backup, if needed, to enable recruitment numbers to be met.
Three cohorts will be studied, depending on the treatment used to control the subject's asthma:Cohort 1 - inhaled salbutamol only, Cohort 2 - inhaled corticosteroid only, Cohort 3 - inhaled corticosteroid plus a LABA
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic, at the investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4 weeks before randomisation.
In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to either 3 nmol Cat-PAD or placebo. Treatments will be administered every 2 weeks (±2 days) for 14 week
In Period 3, Post Treatment Challenge consist of a single visit 24-28 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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Biological: Cat-PAD, Biological: PlaceboAsthmatics using salbutamol only, subjects to receive either Cat-PAD or placebo comparator |
| Cohort 2 | Other | Biological: Cat-PAD, Biological: PlaceboAsthmatics using inhaled corticosteroid, subjects to receive either Cat-PAD or placebo comparator |
| Cohort 3 | Other | Biological: Cat-PAD, Biological: PlaceboAsthmatics using inhaled corticosteroid and LABA, subjects to receive either Cat-PAD or placebo comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged 18-65 years.
- A history of controlled asthma as defined in GINA (2007) on exposure to cats for at least 1 year
- Asthma controlled with:Inhaled salbutamol (Cohort 1), Inhaled corticosteroid (Cohort 2), Inhaled corticosteroid plus a long acting β2agonist (LABA) (Cohort 3) Treatment for asthma must have been stable (drug(s), dose, frequency) for at least 3 months.
- A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) on exposure to cats for at least 1 year.
- Subjects who provide written informed consent.
Key exclusion criteria (29 listed)
- Subjects with asthma falling under GINA (2007) definitions "partly controlled" and "uncontrolled"
- Subjects with a requirement for more than 1000 µg beclomethasone (or equivalent) per day for the treatment of asthma.
- A history of anaphylaxis to cat allergen.
- Subjects with a cat specific IgE >100 kU/L.
- Subjects with an FEV1 <80% of normal
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 |
|---|---|---|
| Cat-PADCat-PAD dose 1x8 administrations 2 weeks apart | Biological | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboPlacebo comparator, 1x8 administrations 2 weeks apart | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Safety and tolerability of multiple intradermal injections of Cat-PAD in cat allergic subjects with controlled asthma
Time frame: 28 weeks
4 secondary outcomes
Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo
Time frame: 28 weeks
Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo
Time frame: 28 weeks
Mean change from baseline in CPT score at PTC after Cat-PAD injection compared to placebo
Time frame: 28 weeks
Mean change from baseline in concentration of cat specific IgE at PTC after Cat-PAD injection compared to placebo
Time frame: 28 weeks
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 6 May 2010.
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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.
Amarjit Cheema, MD principal investigator
Alpha Medical Research
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 10 inclusion and 29 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 6 May 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. 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?
Safety and tolerability of multiple intradermal injections of Cat-PAD in cat allergic subjects with controlled asthma (time frame: 28 weeks). 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 6 May 2010.