Rhinitis, Allergic, PerennialPhase 1/2NCT00829985
Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)
A Phase 1/2 study testing Glycerinated German Cockroach Allergenic Extract in people with Rhinitis, Allergic, Perennial and Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
There is currently no effective way to prevent development of allergic rhinitis (nasal allergies) and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial, Asthma
- What is being tested?
- Glycerinated German Cockroach Allergenic Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 1/2
- 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
- History of perennial allergic rhinitis, asthma, or both for a minimum of 1 year prior to study entry;
- Positive skin prick test to German cockroach;
- No known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo; and
- Willing to sign the written Informed Consent prior to initiation of any study procedures.
Who cannot join
- Cannot perform spirometry at screening;
- Have clinically significant abnormal laboratory values;
- Have an Asthma classification of severe persistent at screening;
- Hospitalized for asthma within the 6 months prior to study entry;
- Life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within the 2 years prior to study entry;
- No access to a telephone;
Show all 18Show fewer
- Received allergen immunotherapy within the last 12 months prior to study entry and plan on initiating or resuming immunotherapy during the study;
- Treatment with anti-immunoglobulin E (anti-IgE) therapy within 1 year of study entry;
- Received an investigational drug within the 30 days prior to study entry and plan on using an investigational drug during the study;
- Experienced nausea, vomiting, abdominal pain or cramps, or diarrhea within the 3 months prior to study entry;
- Refuse to sign the Epinephrine Auto-injector Training Form;
- Does not primarily speak English;
- Plan to move from the area during the study period;
- History of idiopathic anaphylaxis or anaphylaxis grade 3;
- Using tricyclic antidepressants or beta-adrenergic blocker drugs;
- Clinically unacceptable complete blood count (CBC) and liver function tests, as defined by a hemoglobin less than 11.5 in males and 10.0 in females, or platelet counts less than 150,000 and an Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) greater than twice the upper limit of normal;
- Any condition that, in the opinion of the investigator, would interfere with the study; or
- Pregnant or breastfeeding.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Boston University School of Medicine
Boston, Massachusetts, 02118
Childrens Memorial Hospital
Chicago, Illinois, 60614
National Jewish Center
Denver, Colorado, 80206
About this study
Official title: A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-12)
There is currently no effective way to prevent development of allergic rhinitis (nasal allergies) and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. However, detailed research of this approach is limited. The purpose of this study is to evaluate the safety and efficacy of a sublingual cockroach extract given to adults with perennial allergic rhinitis, asthma, or both.
Read the detailed description
Over the last two decades, the prevalence of asthma has dramatically increased in many parts of the world. Currently, there are no effective ways to prevent the development of nasal allergies and asthma, and there are no cures for these diseases. Sublingual immunotherapy (SLIT) may help reduce symptoms of allergy and asthma. The purpose of this study is to evaluate the safety and efficacy of a cockroach extract given sublingually to adults with perennial (year-round) nasal allergies, asthma, or both.
At study entry, participants will receive a dose of placebo and then up to five incremental doses of cockroach extract or placebo at 15-minute intervals while observed by the clinical research staff. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached.
For the next 6 months, participants will take the maximum study dose of cockroach extract or placebo daily at home.
This study will consist of 8 study visits. Skin tests, breathing tests, and blood collection will occur at study screening and other visits during the study. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical and oral exam, breathing test, and blood collection will occur at study entry and all follow-up visits.
- Conditions
- Rhinitis, Allergic, Perennial, Asthma
- Being tested
- Glycerinated German Cockroach Allergenic Extract, Placebo
- Keywords
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Immunotherapy, Asthma, Nasal Allergies, Hypersensitivity
- Medical subject headings
- Rhinitis, Allergic, Perennial, Asthma, Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerinated German Cockroach Allergenic ExtractBiological
Concentrated (1:20 w/v) daily doses of glycerinated German cockroach allergenic extract placed under the tongue to dissolve. The extract is also administered during the preliminary dosing visits in up to five escalating doses or until the maximum study dose (420 microliters, 1:20 w/v) is achieved.
PlaceboBiological
Daily doses of cockroach allergenic extract placebo placed under the tongue to dissolve
| Study group | Role | What they receive |
|---|---|---|
| Glycerinated German Cockroach Allergenic Extract | Experimental | Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved. Receives: Biological: Glycerinated German Cockroach Allergenic Extract |
| Placebo | Placebo comparator | Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in German Cockroach-Specific Serum IgE Over Time
Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.
Measured: Baseline through 6-months of treatment
Secondary outcomes (4)
Difference in German Cockroach-Specific Serum IgG4 Over Time
Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. This ratio is an indicator of immune modulation, however its clinical significance is unclear.
Measured: Baseline through 6-months of treatment
Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)
Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 30 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.
Measured: Baseline through 6-months of treatment
Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)
Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 60 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.
Measured: Baseline through 6-months of treatment
Percent of Participants With the Occurrence of Adverse Events (AE)
Percent of participants who experienced at least one adverse event
Measured: Participant enrollment to end of study (up to 6 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium
- Responsible party
- Sponsor
- Investigators
- Robert Wood, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829985
- Sponsor's protocol ID
- DAIT ICAC-12
- Other IDs
- BioCSI
- Status last verified
- Feb 2017
- First submitted
- 26 Jan 2009
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
Ciprandi G, Contini P, Pistorio A, Murdaca G, Puppo F. Sublingual immunotherapy reduces soluble HLA-G and HLA-A,-B,-C serum levels in patients with allergic rhinitis. Int Immunopharmacol. 2009 Feb;9(2):253-7. doi: 10.1016/j.intimp.2008.11.009. Epub 2008 Dec 17.
PubMed 19100344Passalacqua G, Pawankar R, Baena-Cagnani CE, Canonica GW. Sublingual immunotherapy: where do we stand? Present and future. Curr Opin Allergy Clin Immunol. 2009 Feb;9(1):1-3. doi: 10.1097/ACI.0b013e3283196a9b. No abstract available.
PubMed 19106697Rolland JM, Gardner LM, O'Hehir RE. Allergen-related approaches to immunotherapy. Pharmacol Ther. 2009 Mar;121(3):273-84. doi: 10.1016/j.pharmthera.2008.11.007. Epub 2008 Dec 7.
PubMed 19111571Wood RA, Togias A, Wildfire J, Visness CM, Matsui EC, Gruchalla R, Hershey G, Liu AH, O'Connor GT, Pongracic JA, Zoratti E, Little F, Granada M, Kennedy S, Durham SR, Shamji MH, Busse WW. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52.e6. doi: 10.1016/j.jaci.2013.08.047. Epub 2013 Nov 1.
PubMed 24184147
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-12)
- ClinicalTrials.gov ID
- NCT00829985
- Acronym / sponsor ID
- DAIT ICAC-12
- Conditions
- Rhinitis, Allergic, Perennial, Asthma
- Keywords
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Immunotherapy, Asthma, Nasal Allergies, Hypersensitivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 8 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is currently no effective way to prevent development of allergic rhinitis (nasal allergies) and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. However, detailed research of this approach is limited. The purpose of this study is to evaluate the safety and efficacy of a sublingual cockroach extract given to adults with perennial allergic rhinitis, asthma, or both.
Detailed description
Over the last two decades, the prevalence of asthma has dramatically increased in many parts of the world. Currently, there are no effective ways to prevent the development of nasal allergies and asthma, and there are no cures for these diseases. Sublingual immunotherapy (SLIT) may help reduce symptoms of allergy and asthma. The purpose of this study is to evaluate the safety and efficacy of a cockroach extract given sublingually to adults with perennial (year-round) nasal allergies, asthma, or both.
At study entry, participants will receive a dose of placebo and then up to five incremental doses of cockroach extract or placebo at 15-minute intervals while observed by the clinical research staff. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached.
For the next 6 months, participants will take the maximum study dose of cockroach extract or placebo daily at home.
This study will consist of 8 study visits. Skin tests, breathing tests, and blood collection will occur at study screening and other visits during the study. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical and oral exam, breathing test, and blood collection will occur at study entry and all follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycerinated German Cockroach Allergenic Extract | Experimental | Biological: Glycerinated German Cockroach Allergenic ExtractParticipants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of perennial allergic rhinitis, asthma, or both for a minimum of 1 year prior to study entry;
- Positive skin prick test to German cockroach;
- No known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo; and
- Willing to sign the written Informed Consent prior to initiation of any study procedures.
Key exclusion criteria (18 listed)
- Cannot perform spirometry at screening;
- Have clinically significant abnormal laboratory values;
- Have an Asthma classification of severe persistent at screening;
- Hospitalized for asthma within the 6 months prior to study entry;
- Life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within the 2 years prior to study entry;
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 |
|---|---|---|
| Glycerinated German Cockroach Allergenic ExtractConcentrated (1:20 w/v) daily doses of glycerinated German cockroach allergenic extract placed under the tongue to dissolve. The extract is also administered during the preliminary dosing visits in up to five escalating doses or until the maximum study dose (420 microliters, 1:20 w/v) is achieved. | Biological | Glycerinated German Cockroach Allergenic Extract |
| PlaceboDaily doses of cockroach allergenic extract placebo placed under the tongue to dissolve | Biological | Placebo |
Primary outcome
Difference in German Cockroach-Specific Serum IgE Over Time
Time frame: Baseline through 6-months of treatment
Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.
4 secondary outcomes
Difference in German Cockroach-Specific Serum IgG4 Over Time
Time frame: Baseline through 6-months of treatment
Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)
Time frame: Baseline through 6-months of treatment
Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)
Time frame: Baseline through 6-months of treatment
Percent of Participants With the Occurrence of Adverse Events (AE)
Time frame: Participant enrollment to end of study (up to 6 months post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19100344Ciprandi G, Contini P, Pistorio A, Murdaca G, Puppo F. Sublingual immunotherapy reduces soluble HLA-G and HLA-A,-B,-C serum levels in patients with allergic rhinitis. Int Immunopharmacol. 2009 Feb;9(2):253-7. doi: 10.1016/j.intimp.2008.11.009. Epub 2008 Dec 17.
- Background: PubMed 19106697Passalacqua G, Pawankar R, Baena-Cagnani CE, Canonica GW. Sublingual immunotherapy: where do we stand? Present and future. Curr Opin Allergy Clin Immunol. 2009 Feb;9(1):1-3. doi: 10.1097/ACI.0b013e3283196a9b. No abstract available.
- Background: PubMed 19111571Rolland JM, Gardner LM, O'Hehir RE. Allergen-related approaches to immunotherapy. Pharmacol Ther. 2009 Mar;121(3):273-84. doi: 10.1016/j.pharmthera.2008.11.007. Epub 2008 Dec 7.
- Results publication: PubMed 24184147Wood RA, Togias A, Wildfire J, Visness CM, Matsui EC, Gruchalla R, Hershey G, Liu AH, O'Connor GT, Pongracic JA, Zoratti E, Little F, Granada M, Kennedy S, Durham SR, Shamji MH, Busse WW. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52.e6. doi: 10.1016/j.jaci.2013.08.047. Epub 2013 Nov 1.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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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 Wood, MD study chair
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Glycerinated German Cockroach Allergenic Extract in people with Rhinitis, Allergic, Perennial and Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 4 inclusion and 18 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 8 Mar 2013). 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?
Difference in German Cockroach-Specific Serum IgE Over Time (time frame: Baseline through 6-months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00829985, which also lists 4 linked publications.
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 21 Mar 2017.