AsthmaPhase 1/2BioCSI-2NCT01380327
Biomarkers of Cockroach Sublingual Immunotherapy 2
A Phase 1/2 study testing Cockroach Sublingual Immunotherapy (SLIT) - Low Dose and Cockroach Sublingual Immunotherapy (SLIT) - High Dose in people with Asthma and Perennial Allergic Rhinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma, Perennial Allergic Rhinitis
- What is being tested?
- Cockroach Sublingual Immunotherapy (SLIT) - Low Dose and Cockroach Sublingual Immunotherapy (SLIT) - High Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2011to Jun 2012
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a history of perennial allergic rhinitis, asthma, or both, before study entry. For those with asthma:
- a diagnosis of asthma will be defined as a report by the participant that they have had a clinical diagnosis of asthma made by a physician over a year ago
- the participant's asthma must be well controlled as defined by: ii. a forced expiratory volume at one second (FEV1) greater than or equal to 80% predicted value with or without controller medication ii. albuterol use for no more than 3 days per week in each of the previous 2 weeks for asthma symptoms (not including exercise prophylaxis)
- Are sensitive to German cockroach (Blattella germanica) as documented by a positive (>/=3 mm greater than negative control) skin prick test result and detectable German cockroach specific IgE (>/=0.35 kUA/L)
- Have no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo
- Parent or legally authorized representative (LAR) of child is willing to sign the written Informed Consent prior to initiation of any study procedure
Who cannot join
- Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception)
- Cannot perform spirometry or peak flow at screening
- Have an asthma severity classification at recruitment of severe persistent, using the National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
- requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid
- have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months
- have been treated with depot steroids within the last 12 months
Show all 23Show fewer
- have been hospitalized for asthma within the 6 months prior to recruitment
- have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment
- Do not have access to a phone (needed for scheduling appointments)
- Have received allergen immunotherapy in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study
- Have previously been treated with anti-IgE therapy within 1 year of recruitment
- Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study
- Have in the last 3 months prior to recruitment experienced on average >/=1 day per week any of the symptoms below:
- nausea or vomiting
- abdominal pain or cramps severe enough to interfere with daily activities (excluding those associated with menstruation).
- diarrhea
- Refuse to sign the Epinephrine Auto-injector Training Form
- Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:
- Do not primarily speak English
- Plan to move from the area during the study period
- Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher
- Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the patient (e.g., gastrointestinal disease, gastroesophageal reflux disease, chronic infections, scleroderma, hepatic, and gallbladder disease)
- Are using tricyclic antidepressants or beta-adrenergic blocker drugs (either oral and/or topical route[s] of administration)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
About this study
Official title: A Biomarker-Based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Children With Asthma and/or Perennial Allergic Rhinitis
This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.
Read the detailed description
Over the past two decades, scientific evidence has shown that the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the National Institute of Allergy and Infectious Diseases (NIAID) Inner City Asthma Consortium (ICAC) is ultimately to conduct a large multi-center trial of cockroach sublingual immunotherapy (SLIT) in inner-city asthma. As a step toward achieving this goal, ICAC is conducting a clinical trial comparing two doses of glycerinated German cockroach (Blattella germanica) allergenic extract to placebo, administered under the tongue (sublingual).
- Conditions
- Asthma, Perennial Allergic Rhinitis
- Being tested
- Cockroach Sublingual Immunotherapy (SLIT) - Low Dose, Placebo, Cockroach Sublingual Immunotherapy (SLIT) - High Dose
- Keywords
- cockroach, immunotherapy, sublingual immunotherapy (SLIT), inner city asthma
- Medical subject headings
- Asthma, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cockroach Sublingual Immunotherapy (SLIT) - Low DoseBiological
Also called Blattella germanica
Participants are randomized to receive daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
PlaceboOther
Also called German cockroach (Blattella germanica) placebo
Participants are randomized to receive either daily (low dose) or twice-daily (high dose) placebo treatment placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
Cockroach Sublingual Immunotherapy (SLIT) - High DoseBiological
Also called Blattella germanica
Participants are randomized to receive twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
| Study group | Role | What they receive |
|---|---|---|
| Cockroach Sublingual Immunotherapy (SLIT) - Low Dose | Experimental | Glycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 420 microliters daily Receives: Biological: Cockroach Sublingual Immunotherapy (SLIT) - Low Dose |
| Placebo | Placebo comparator | Placebo administered sublingually not to exceed the maximally tolerated dose of either 1.) 420 microliters daily (placebo - low dose randomization) or 2.) 840 microliters twice daily (placebo - high dose randomization) Receives: Other: Placebo |
| Cockroach Sublingual Immunotherapy (SLIT) - High Dose | Experimental | Glycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 840 microliters taken twice daily Receives: Biological: Cockroach Sublingual Immunotherapy (SLIT) - High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in German Cockroach-Specific Serum IgE Over Time
Outcome is the ratio of geometric means for baseline versus 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 3 months of treatment
Secondary outcomes (4)
Change in German Cockroach-Specific Serum IgG Over Time
Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin G (IgG). This result is an indicator of immune modulation over time, however its clinical significance is unclear.
Measured: Baseline through 3 months of treatment
Change in German Cockroach-Specific Serum IgG4 Over Time
Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin subclass 4 (IgG4). This result is an indicator of immune modulation over time, however its clinical significance is unclear.
Measured: Baseline through 3 months of treatment
Change in IgE Fragment Antibody Binding (FAB) Activity Over Time
Outcome is change in mean IgE FAB activity level from baseline to post-baseline (status post 3 months of treatment). Serum from cockroach sublingual immunotherapy (SLIT)-treated participants were analyzed to determine if treatment inhibits in-vitro cockroach SLIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.(Reference: Shamji MH et al. The IgE-facilitated allergen binding (FAB) assay: validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses. J Immunol Methods 2006;317(1-2): 71-9).
Measured: Baseline through 3 months of treatment
Percent of Participants With the Occurrence of Adverse Events (AEs)
Percent of participants who experienced at least one AE.
Measured: Participant enrollment to end of study (up to 3 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 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert Wood, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380327
- Sponsor's protocol ID
- DAIT ICAC-17
- Acronym
- BioCSI-2
- Status last verified
- Jun 2014
- First submitted
- 22 Jun 2011
- Last updated
- 11 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wood 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 11 Jun 2014. 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 Children With Asthma and/or Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01380327
- Acronym / sponsor ID
- BioCSI-2 / DAIT ICAC-17
- Conditions
- Asthma, Perennial Allergic Rhinitis
- Keywords
- cockroach, immunotherapy, sublingual immunotherapy (SLIT), inner city asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 30 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.
Detailed description
Over the past two decades, scientific evidence has shown that the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the National Institute of Allergy and Infectious Diseases (NIAID) Inner City Asthma Consortium (ICAC) is ultimately to conduct a large multi-center trial of cockroach sublingual immunotherapy (SLIT) in inner-city asthma. As a step toward achieving this goal, ICAC is conducting a clinical trial comparing two doses of glycerinated German cockroach (Blattella germanica) allergenic extract to placebo, administered under the tongue (sublingual).
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 |
|---|---|---|
| Cockroach Sublingual Immunotherapy (SLIT) - Low Dose | Experimental | Biological: Cockroach Sublingual Immunotherapy (SLIT) - Low DoseGlycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 420 microliters daily |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered sublingually not to exceed the maximally tolerated dose of either 1.) 420 microliters daily (placebo - low dose randomization) or 2.) 840 microliters twice daily (placebo - high dose randomization) |
| Cockroach Sublingual Immunotherapy (SLIT) - High Dose | Experimental | Biological: Cockroach Sublingual Immunotherapy (SLIT) - High DoseGlycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 840 microliters taken twice daily |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Have a history of perennial allergic rhinitis, asthma, or both, before study entry. For those with asthma:
- Are sensitive to German cockroach (Blattella germanica) as documented by a positive (>/=3 mm greater than negative control) skin prick test result and detectable German cockroach specific IgE (>/=0.35 kUA/L)
- Have no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo
- Parent or legally authorized representative (LAR) of child is willing to sign the written Informed Consent prior to initiation of any study procedure
Key exclusion criteria (23 listed)
- Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception)
- Cannot perform spirometry or peak flow at screening
- Have an asthma severity classification at recruitment of severe persistent, using the National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
- Do not have access to a phone (needed for scheduling appointments)
- Have received allergen immunotherapy in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study
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 |
|---|---|---|
| Cockroach Sublingual Immunotherapy (SLIT) - Low DoseAlso: Blattella germanicaParticipants are randomized to receive daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved. | Biological | Cockroach Sublingual Immunotherapy (SLIT) - Low Dose |
| PlaceboAlso: German cockroach (Blattella germanica) placeboParticipants are randomized to receive either daily (low dose) or twice-daily (high dose) placebo treatment placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved. | Other | Placebo |
| Cockroach Sublingual Immunotherapy (SLIT) - High DoseAlso: Blattella germanicaParticipants are randomized to receive twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved. | Biological | Cockroach Sublingual Immunotherapy (SLIT) - High Dose |
Primary outcome
Change in German Cockroach-Specific Serum IgE Over Time
Time frame: Baseline through 3 months of treatment
Outcome is the ratio of geometric means for baseline versus 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
Change in German Cockroach-Specific Serum IgG Over Time
Time frame: Baseline through 3 months of treatment
Change in German Cockroach-Specific Serum IgG4 Over Time
Time frame: Baseline through 3 months of treatment
Change in IgE Fragment Antibody Binding (FAB) Activity Over Time
Time frame: Baseline through 3 months of treatment
Percent of Participants With the Occurrence of Adverse Events (AEs)
Time frame: Participant enrollment to end of study (up to 3 months post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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)Link provided by the sponsor.
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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
5 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 Cockroach Sublingual Immunotherapy (SLIT) - Low Dose and Cockroach Sublingual Immunotherapy (SLIT) - High Dose in people with Asthma and Perennial Allergic Rhinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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 6 inclusion and 23 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 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 30 May 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?
Change in German Cockroach-Specific Serum IgE Over Time (time frame: Baseline through 3 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 NCT01380327, which also lists 1 linked publication.
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 11 Jun 2014.