AllergyPhase 2NCT00689299
Phase 2 Study in Adults Sensitized to Cat
A Phase 2 study testing Standardized Allergenic Extract, Cat Hair in people with Allergy, run by Antigen Laboratories, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for cat hair (Felis domesticus) administered by the oral/sublingual route. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergy
- What is being tested?
- Standardized Allergenic Extract, Cat Hair
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients between ages of 18 and 55 years (inclusive).
- Written informed consent to participate in the study.
- Documented allergy to cat hair as demonstrated by a positive epicutaneous skin test (wheal >3 mm) and symptoms of allergic rhinitis during exposure to cats.
- Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the 4 week follow-up period following the last dose of clinical trial: hormonal begun >30 days prior to screening, barrier, intrauterine device or vasectomized partner (6 months minimum).
- No clinically significant abnormal findings on physical examination, with the exception of head, ears, eyes, nose, and throat (HEENT) findings consistent with allergic rhinitis, medical history, or clinical laboratory results during screening which would jeopardize the safety of the subject or impact validity of study results.
Who cannot join
- Previous allergen immunotherapy (subcutaneous immunotherapy (SCIT), oral immunotherapy, sublingual immunotherapy (SLIT) or recombinant peptide) for cat within 24 months of Screening Visit.
- History of severe allergic reaction requiring medical intervention.
- Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide).
- Allergy to any of the non-antigen ingredients in the study drug formulation, including, but not limited to: Food, Drug and Cosmetic Act (FD\&C) Yellow #5, Red #40 and Blue #1; sodium chloride; sodium bicarbonate; and glycerine.
- History of asthma requiring daily medication.
- Subjects receiving anti-IgE monoclonal antibodies.
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- Congenital immune deficiency or acquired immune suppression. Causes of acquired immune suppression may include, but are not limited to, systemic illnesses such as malignancy and infection, the use of medications such as corticosteroids and chemotherapeutic agents, and radiation therapy.
- History of organ transplant, hematologic malignancy, autoimmune disease, myocardial infarction, or congestive heart failure.
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Inability or unwillingness to stop using drugs that may inhibit the wheal-and-flare reaction or rhinitic response prior to the study and for the duration of dosing clinical trial material (CTM), with the exception of protocol-specified rescue medications provided by the study site for use after Study Day 0. This includes, but is not limited to:
- Decongestants for 3 days prior to Study Day 0
- H1 antagonists (antihistamines) (oral, nasal or ocular) for 7 days prior to Study Day 0
- Topical intranasal corticosteroids for 14 days prior to Study Day 0
- Cromolyn or nedocromil for 14 days prior to Study Day 0
- Systemic corticosteroids for 28 days prior to Study Day 0
- Tricyclic antidepressants for 28 days prior to Study Day 0
- Leukotriene modifiers for 7 days prior to study Day 0
- Inability or unwillingness to stop using drugs that may inhibit the ability to treat a severe allergic adverse event. This includes, but is not limited to: beta blockers such as atenolol (Tenormin®), metoprolol (Lopressor®, Toprol-XL®) and propranolol (Inderal®, Inderal LA®) for 14 days prior to Study Day 0 and for the duration of the study.
- Female subjects who are trying to conceive, are pregnant, or are lactating.
- Positive serum pregnancy test at screening or a positive human chorionic gonadotropin (HCG) urine test on Study Day 0 prior to administration of study drug for women of childbearing potential.
- Positive blood screen for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbSAg), or Hepatitis C.
- Forced Expiratory Volume in 1 second (FEV1) <70% of the predicted value.
- History of alcohol or drug abuse within the year prior to the Screening Visit, or current evidence of substance dependence or abuse.
- Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Allergen Response and Research Center
Marietta, Georgia, 30062
Allergy & Asthma Medical Group & Research Center
San Diego, California, 92123
Clinical Research Center
St Louis, Missouri, 63141
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy (SLIT) in Adults Sensitized to the Standardized Allergenic Extract, Cat Hair (Felis Domesticus)
The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for cat hair (Felis domesticus) administered by the oral/sublingual route.
Read the detailed description
This was a phase 2, randomized, double-blind, placebo-controlled, parallel groups study conducted in 3 centers in the US (NCT00689299). Study drug was sublingually dosed once daily as 0.15 mL of US standardized cat hair extract dosed either undiluted, as 1:10 dilution, or placebo. Target dose was obtained on Day 3 of dose titration escalating through 1:100 and 1:10 dilutions on Day 1 and Day 2 in the high dose group or placebo and 1:100 dilutions in the low dose group. Treatment duration was 20 weeks. Adult (>18 years) study subjects had positive history for cat allergy without asthma, positive skin test to cat allergen, absence of immunotherapy during the prior 2 years, and absence of other confounding baseline conditions. The primary outcome parameter was average Total Symptom Score (TSS) during a 1-hour cat chamber exposure. TSS is the sum of 7 items rated from 0 - 3 (none to severe) for nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) and non-nasal symptoms (eye watering, eye itching, and itching palate/ ear/ throat).
- Conditions
- Allergy
- Being tested
- Standardized Allergenic Extract, Cat Hair, Placebo
- Keywords
- Sublingual Immunotherapy (SLIT), Non-seasonal allergic rhinitis, Immunotherapy, Allergic rhinitis, Cat, Perennial allergy, Non-seasonal allergy
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic, Perennial, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Allergenic Extract, Cat HairBiological
Also called Standardized Cat Hair Allergenic Extract
Standardized Cat Hair Allergenic Extract sublingual drops
PlaceboBiological
Placebo Sublingual Drops
| Study group | Role | What they receive |
|---|---|---|
| Dose Group C | Placebo comparator | Standardized Allergenic Extract, Cat Hair (Felis domesticus) placebo Receives: Biological: Placebo |
| Dose Group A | Active comparator | Standardized Allergenic Extract, Cat Hair (Felis domesticus) 0.21 Units Receives: Biological: Standardized Allergenic Extract, Cat Hair |
| Dose Group B | Active comparator | Standardized Allergenic Extract, Cat Hair (Felis domesticus)2.1 units Receives: Biological: Standardized Allergenic Extract, Cat Hair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on a Scale (Average of Total Symptom Scores)
Sum of individual symptoms scores, 7 items, 21 points maximum
Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat.
Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antigen Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert B. Berkowitz, M.D., Principal investigator, Allergen Response Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689299
- Sponsor's protocol ID
- ALI002-08
- Other IDs
- ALI002-08
- Status last verified
- Apr 2014
- First submitted
- 30 May 2008
- Last updated
- 1 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy (SLIT) in Adults Sensitized to the Standardized Allergenic Extract, Cat Hair (Felis Domesticus)
- ClinicalTrials.gov ID
- NCT00689299
- Acronym / sponsor ID
- ALI002-08
- Conditions
- Allergy
- Keywords
- Sublingual Immunotherapy (SLIT), Non-seasonal allergic rhinitis, Immunotherapy, Allergic rhinitis, Cat, Perennial allergy, Non-seasonal allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Antigen Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for cat hair (Felis domesticus) administered by the oral/sublingual route.
Detailed description
This was a phase 2, randomized, double-blind, placebo-controlled, parallel groups study conducted in 3 centers in the US (NCT00689299). Study drug was sublingually dosed once daily as 0.15 mL of US standardized cat hair extract dosed either undiluted, as 1:10 dilution, or placebo. Target dose was obtained on Day 3 of dose titration escalating through 1:100 and 1:10 dilutions on Day 1 and Day 2 in the high dose group or placebo and 1:100 dilutions in the low dose group. Treatment duration was 20 weeks. Adult (>18 years) study subjects had positive history for cat allergy without asthma, positive skin test to cat allergen, absence of immunotherapy during the prior 2 years, and absence of other confounding baseline conditions. The primary outcome parameter was average Total Symptom Score (TSS) during a 1-hour cat chamber exposure. TSS is the sum of 7 items rated from 0 - 3 (none to severe) for nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) and non-nasal symptoms (eye watering, eye itching, and itching palate/ ear/ throat).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Group C | Placebo comparator | Biological: PlaceboStandardized Allergenic Extract, Cat Hair (Felis domesticus) placebo |
| Dose Group A | Active comparator | Biological: Standardized Allergenic Extract, Cat HairStandardized Allergenic Extract, Cat Hair (Felis domesticus) 0.21 Units |
| Dose Group B | Active comparator | Biological: Standardized Allergenic Extract, Cat HairStandardized Allergenic Extract, Cat Hair (Felis domesticus)2.1 units |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female patients between ages of 18 and 55 years (inclusive).
- Written informed consent to participate in the study.
- Documented allergy to cat hair as demonstrated by a positive epicutaneous skin test (wheal >3 mm) and symptoms of allergic rhinitis during exposure to cats.
- Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the 4 week follow-up period following the last dose of clinical trial: hormonal begun >30 days prior to screening, barrier, intrauterine device or vasectomized partner (6 months minimum).
- No clinically significant abnormal findings on physical examination, with the exception of head, ears, eyes, nose, and throat (HEENT) findings consistent with allergic rhinitis, medical history, or clinical laboratory results during screening which would jeopardize the safety of the subject or impact validity of study results.
Key exclusion criteria (24 listed)
- Previous allergen immunotherapy (subcutaneous immunotherapy (SCIT), oral immunotherapy, sublingual immunotherapy (SLIT) or recombinant peptide) for cat within 24 months of Screening Visit.
- History of severe allergic reaction requiring medical intervention.
- Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide).
- Allergy to any of the non-antigen ingredients in the study drug formulation, including, but not limited to: Food, Drug and Cosmetic Act (FD\&C) Yellow #5, Red #40 and Blue #1; sodium chloride; sodium bicarbonate; and glycerine.
- History of asthma requiring daily medication.
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 |
|---|---|---|
| Standardized Allergenic Extract, Cat HairAlso: Standardized Cat Hair Allergenic ExtractStandardized Cat Hair Allergenic Extract sublingual drops | Biological | Dose Group A, Dose Group B |
| PlaceboPlacebo Sublingual Drops | Biological | Dose Group C |
Primary outcome
Scores on a Scale (Average of Total Symptom Scores)
Time frame: 20 weeks
Sum of individual symptoms scores, 7 items, 21 points maximum Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat. Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert B. Berkowitz, M.D. principal investigator
Allergen Response Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standardized Allergenic Extract, Cat Hair in people with Allergy, run by Antigen Laboratories, Inc. at 3 sites in United States.
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 5 inclusion and 24 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Scores on a Scale (Average of Total Symptom Scores) (time frame: 20 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 1 May 2014.