Cat AllergyPhase 2NCT00987909
Exposure Chamber Trial With Cat Immunotherapy
A Phase 2 study testing Specific allergen immunotherapy in people with Cat Allergy, run by ALK-Abelló A/S at 1 site in Canada.
Trial summary
The main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients. 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?
- Specific allergen immunotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to May 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
- A history of rhinoconjunctivitis on exposure to cats
- Positive Skin Prick Test response (wheal diameter at least 3 mm larger than the negative control
- Positive specific IgE against Fel d1 (at least IgE Class 2)
- Minimum qualifying rhinoconjunctivitis symptom score during EEC exposure at Visit 2
Who cannot join
- Uncontrolled asthma within the past 12 months, or asthma requiring regular use of inhaled corticosteroids
- FEV1 less than 80% of predicted
- Subjects who suffer from significant seasonal allergic rhinoconjunctivitis, and cannot complete the clinical trial outside the local pollen season, or who have significant allergy to other allergens (e.g. other animals or house dust mites) that cannot be avoided during the trial period
- Subjects who cannot tolerate baseline challenge in the Environmental Exposure Chamber
- History of anaphylaxis with cardio/respiratory symptoms
- A medical history of severe drug or food allergy with symptoms such as difficulty breathing, swelling of the face or a feeling of severe dizziness or increased heart rate
Show all 9Show fewer
- Chronic urticaria
- History of severe cardiac disease
- Treatment with immunosuppressives, anti-IgE monoclonal antibodies, tricyclic antidepressants or MAOIs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial Assessing the Tolerability and Pharmacodynamic Effect of US SLIT Cat Hair in Subject With Cat Allergy and Investigating Efficacy Variables in an Environmental Exposure Chamber Model
The main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients.
- Conditions
- Cat Allergy
- Being tested
- Specific allergen immunotherapy (placebo), Specific allergen immunotherapy
- Keywords
- Cat, Allergy, Immunotherapy, Sublingual, Exposure chamber, Safety, Rhinoconjunctivitis
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific allergen immunotherapy (placebo)Biological
Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks
Specific allergen immunotherapyBiological
Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.
Specific allergen immunotherapyBiological
Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks
Specific allergen immunotherapyBiological
Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Solution resembling the active solutions, but without allergen extract Receives: Biological: Specific allergen immunotherapy (placebo) |
| Cat hair allergen extract, dose group 1 | Experimental | Not described Receives: Biological: Specific allergen immunotherapy |
| Cat hair allergen extract, dose group 2 | Experimental | Not described Receives: Biological: Specific allergen immunotherapy |
| Cat hair allergen extract, dose group 3 | Experimental | Not described Receives: Biological: Specific allergen immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: During 16 weeks of treatment
Secondary outcomes (7)
Rhinoconjunctivitis symptom score
Measured: After 0, 8, and 16 weeks of treatment
Overall rhinoconjunctivitis symptom score
Measured: After 0, 8, and 16 weeks of treatment
Acoustic Rhinometry
Measured: After 0, 8, and 16 weeks of treatment
Environmental Exposure Chamber Quality of Life
Measured: After 0, 8, and 16 weeks of treatment
Serum immunology
Measured: After 0, 8, and 16 weeks of treatment
Nasal secretion immunology
Measured: After 0 and 16 weeks of treatment
Safety lab testing (clinical chemistry, haematology, urinalysis)
Measured: After 0 and 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMay 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Investigators
- Deepen Patel, MD, CCFP, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987909
- Sponsor's protocol ID
- US-C-01
- Other IDs
- Cetero Research - P2CR09001, Health Canada - 9427-A1556-24C
- Status last verified
- Aug 2010
- First submitted
- 28 Sep 2009
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Assessing the Tolerability and Pharmacodynamic Effect of US SLIT Cat Hair in Subject With Cat Allergy and Investigating Efficacy Variables in an Environmental Exposure Chamber Model
- ClinicalTrials.gov ID
- NCT00987909
- Acronym / sponsor ID
- US-C-01
- Conditions
- Cat Allergy
- Keywords
- Cat, Allergy, Immunotherapy, Sublingual, Exposure chamber, Safety, Rhinoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Oct 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.
The main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Specific allergen immunotherapy (placebo)Solution resembling the active solutions, but without allergen extract |
| Cat hair allergen extract, dose group 1 | Experimental | Biological: Specific allergen immunotherapy |
| Cat hair allergen extract, dose group 2 | Experimental | Biological: Specific allergen immunotherapy |
| Cat hair allergen extract, dose group 3 | Experimental | Biological: Specific allergen immunotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A history of rhinoconjunctivitis on exposure to cats
- Positive Skin Prick Test response (wheal diameter at least 3 mm larger than the negative control
- Positive specific IgE against Fel d1 (at least IgE Class 2)
- Minimum qualifying rhinoconjunctivitis symptom score during EEC exposure at Visit 2
Key exclusion criteria (9 listed)
- Uncontrolled asthma within the past 12 months, or asthma requiring regular use of inhaled corticosteroids
- FEV1 less than 80% of predicted
- Subjects who suffer from significant seasonal allergic rhinoconjunctivitis, and cannot complete the clinical trial outside the local pollen season, or who have significant allergy to other allergens (e.g. other animals or house dust mites) that cannot be avoided during the trial period
- Subjects who cannot tolerate baseline challenge in the Environmental Exposure Chamber
- History of anaphylaxis with cardio/respiratory symptoms
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 |
|---|---|---|
| Specific allergen immunotherapy (placebo)Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks | Biological | Placebo |
| Specific allergen immunotherapyDrops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks. | Biological | Cat hair allergen extract, dose group 1 |
| Specific allergen immunotherapyDrops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks | Biological | Cat hair allergen extract, dose group 2 |
| Specific allergen immunotherapyDrops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks | Biological | Cat hair allergen extract, dose group 3 |
Primary outcome
Adverse Events
Time frame: During 16 weeks of treatment
7 secondary outcomes
Rhinoconjunctivitis symptom score
Time frame: After 0, 8, and 16 weeks of treatment
Overall rhinoconjunctivitis symptom score
Time frame: After 0, 8, and 16 weeks of treatment
Acoustic Rhinometry
Time frame: After 0, 8, and 16 weeks of treatment
Environmental Exposure Chamber Quality of Life
Time frame: After 0, 8, and 16 weeks of treatment
Serum immunology
Time frame: After 0, 8, and 16 weeks of treatment
Nasal secretion immunology
Time frame: After 0 and 16 weeks of treatment
Safety lab testing (clinical chemistry, haematology, urinalysis)
Time frame: After 0 and 16 weeks of treatment
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 18 Aug 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.
Deepen Patel, MD, CCFP 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 Specific allergen immunotherapy in people with Cat Allergy, run by ALK-Abelló A/S 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 9 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 18 Aug 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?
Adverse Events (time frame: During 16 weeks 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 18 Aug 2010.