Persistent AsthmaPhase 2CRITICALNCT03541187
Cockroach Immunotherapy in Children and Adolescents
A Phase 2 study testing German cockroach allergenic extract in people with Persistent Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
Trial summary
Scientific evidence has shown that, over the past two decades, 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Persistent Asthma
- What is being tested?
- German cockroach allergenic extract
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 11 sitesUnited States
- Study dates
- 16 Jul 2018to 3 Jun 2022
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- And/or parent guardian must be able to understand and provide informed consent;
- Age at date of recruitment (e.g., screening): 8 to 17 years of age
- Have a primary place of residence in one of the pre-selected recruitment census tracts (Reference: Inner-City Asthma Consortium):
- --Note: Subjects who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly-funded health insurance will qualify for inclusion.
- Have a history of persistent asthma, for a minimum of 1 year before study entry:
- A diagnosis of asthma will be defined as a report by the caretaker that the subject had a clinical diagnosis of asthma made by a clinician ≥1 year ago, resulting in a prescription of preventative asthma medication, and
Show all 16Show fewer
- Must have persistent asthma as defined by the current need for at least 88 mcg fluticasone (or the equivalent of another inhaled corticosteroid) to control asthma at the time of screening.
- At the time of randomization, the subject's asthma must be well controlled as defined by:
- A Forced Expiratory Volume in 1 second (FEV1) ≥80% predicted, and
- An Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) score ≥20.
- Is sensitive to German cockroach as documented by:
- a positive (≥3 mm greater than negative control) skin prick test result, and
- detectable German cockroach specific Immunoglobulin E (IgE) (≥ 0.35 kUA/L).
- Have no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo;
- Have a positive cockroach nasal challenge, as defined by reaching a Total Nasal Symptom Score (TNSS) of ≥6 or a sneezing score of 3 at dose 2 or above during the challenge before randomization; and
- Have documentation of current medical insurance with prescription coverage at randomization.
Who cannot join
- Unable or unwilling to give written informed consent or comply with the study protocol;
- That is pregnant or lactating;
- That are post-menarcheal females must be abstinent or use a medically acceptable birth control method throughout their participation in the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
- That cannot perform spirometry and peak flow at treatment randomization;
- That have an asthma severity classification at the time of treatment randomization of severe persistent, using the The National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
- Requires a dose >500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid,
Show all 28Show fewer
- Has received more than 2 courses of oral or parenteral corticosteroids in the last 12 months or one course within the last 3 months prior to study entry,
- Has been treated with depot steroids within the 3 months prior to study entry,
- Has been hospitalized for asthma within the 6 months prior to study entry, or
- Has had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to study entry.
- Does not have access to a phone (needed for scheduling appointments);
- Has received allergen immunotherapy (Sublingual Immunotherapy [SLIT] or Subcutaneous Immunotherapy [SCIT]) in the last 12 months or, who plan to initiate or resume allergen immunotherapy during the study;
- Has received biologic therapy (e.g., anti-Immunoglobulin E [IgE], anti-IL-4, anti-IL-5) within 6 months of study entry;
- Has received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study;
- Has past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may:
- pose additional risks from participation in the study,
- may interfere with the subject's ability to comply with study requirements, or
- that may impact the quality or interpretation of the data obtained from the study.
- Who have nasal polyps or other major structural abnormalities in their nasal cavities as assessed by anterior rhinoscopy,
- Who meet any of the following criteria are not eligible for enrollment and may not be reassessed:
- That plan to move from the area during the study period,
- Have a history of anaphylaxis grade 3 or higher as defined by World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System,
- 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 product or pose additional risk to the subject,
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator,
- may pose additional risks from participation in the study,
- may interfere with the subject's ability to comply with study requirements,
- or that may impact the quality or interpretation of the data obtained from the study.
- Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral and topical).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21205
Boston Medical Center
Boston, Massachusetts, 02118
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039
University of Texas Southwestern Medical School
Dallas, Texas, 75390-8859
Henry Ford Health System: Division of Allergy and Immunology
Detroit, Michigan, 48202
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
St. Louis Children's Hospital: Allergy, Immunology and Pulmonary Medicine Program
St Louis, Missouri, 63110
Children's National Medical Center - IMPACT DC
Washington D.C., District of Columbia, 20010
About this study
Scientific evidence has shown that, over the past two decades, 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 Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of cockroach immunotherapy in inner city asthma.
The primary objective of the study is to determine if the response to nasal allergen challenge (NAC) will be changed with treatment with cockroach subcutaneous immunotherapy (SCIT) treatment.
Read the detailed description
This is a 1:1 randomized, double-masked (blind), placebo-controlled, multicenter trial with 2 treatment arms:
- German Cockroach Subcutaneous Immunotherapy (SCIT) + guideline-based standard asthma care, OR
- Placebo (for German Cockroach Subcutaneous Immunotherapy [SCIT]) + guideline-based standard asthma care
Eighty participants 8 to 17 years of age who are sensitized to cockroach, have asthma, and a positive cockroach Nasal Allergen Challenge (NAC) before treatment randomization will be enrolled.
- Conditions
- Persistent Asthma
- Being tested
- German cockroach allergenic extract, Placebo for German cockroach allergenic extract
- Keywords
- cockroach, immunotherapy, inner city asthma, subcutaneous immunotherapy (SCIT), Nasal Allergen Challenge (NAC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
German cockroach allergenic extractBiological
Also called Blattella germanica allergenic extract
Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467).
Placebo for German cockroach allergenic extractBiological
Also called Placebo for Blattella germanica allergenic extract
Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%).
| Study group | Role | What they receive |
|---|---|---|
| G. cockroach allergenic extract | Experimental | Subcutaneous immunotherapy (SCIT): German cockroach allergenic extract. 40 participants 8 to 14 years of age will be randomized to this treatment arm.
-Up to 2 doses of the assigned SCIT treatment will be given weekly during dose escalation, separated by a minimum of 2 days. After maintenance dose is achieved, participants will receive three maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Receives: Biological: German cockroach allergenic extract |
| Placebo | Placebo comparator | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 14 years of age will be randomized to this treatment arm.
-Up to 2 doses of the assigned SCIT treatment will be given weekly during dose escalation, separated by a minimum of 2 days. Once the maintenance dose is achieved, participants will receive three maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Receives: Biological: Placebo for German cockroach allergenic extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo
The study's primary endpoint is the mean TNSS change from baseline to 12 months, calculated as the difference between baseline and 12-month mean TNSS up to baseline responsive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling mean TNSS difference with factors for treatment arm, site, and baseline mean TNSS. Least square means (LSmeans), SEs, difference in LSmeans between treatment and placebo groups, 95% CI, and p-value are reported. A greater change in the LSmeans indicates a better outcome.
Measured: After 12 months
Secondary outcomes (5)
Number of Immunotherapy Related Adverse Events and Number of Immunotherapy Related Serious Adverse Events in the Course of Treatment.
Summary tables will present the total number of Immunotherapy related adverse event within the course of treatment.
Measured: After 12 months
Change in Area Under the Curve (AUC) Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo
The Total Nasal Symptom Score (TNSS) Area under the curve (AUC) will be calculated separately at baseline and 12 months for each subject using the trapezoidal rule and divided by their baseline reactive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling AUC TNSS with factors for treatment arm, site, and baseline TNSS AUC. Least square means (LSmeans), SEs, difference in LSmeans between treatment and placebo groups, 95% CI, and p-value are reported. A greater change in the LSmeans indicates a better outcome.
Measured: After 12 months
Change in 12-month Responsive Dose Between Cockroach SCIT and Placebo
The 12-month responsive dose is being calculated as the first dose that triggers a reaction of TNSS (Total Nasal Symptom Score) greater than or equal to 6 or a sneeze score of 3, whichever occurs first, in a sequence of up to 9 doses. To estimate the hazard ratio and 95% confidence interval, we are conducting an analysis using Cox regression with censoring, while controlling for the baseline responsive dose and site. Participants who do not experience a reaction before reaching the last dose will be considered right-censored.
Measured: After 12 months
Change in Log-transformed German Cockroach-specific IgE From Baseline to 12 Months Between Cockroach SCIT and Placebo
The difference in log-transformed German Cockroach-specific IgE between baseline and 12 months is being modeled using ANCOVA with factors for treatment arm, site, and the respective log-transformed IgE baseline as covariates. For each treatment group, we present least square means (LSmeans) and their associated standard errors (SEs). We report the difference in LSmeans between the treatment and placebo groups, along with the associated 95% confidence interval (CI) and p-value.
Measured: After 12 months
Change in Log-transformed German Cockroach-specific IgG4 From Baseline to 12 Months Between Cockroach SCIT and Placebo
The difference in log-transformed German Cockroach-specific IgG4 between baseline and 12 months is being modeled using ANCOVA with factors for treatment arm, site, and the respective log-transformed IgG4 baseline as covariates. For each treatment group, we present least square means (LSmeans) and their associated standard errors (SEs). We report the difference in LSmeans between the treatment and placebo groups, along with the associated 95% confidence interval (CI) and p-value.
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start16 Jul 2018
- Primary completion2 Jun 2022
- Study completion3 Jun 2022
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 (2)Papers the sponsor has linked to this study.
- Other trials for Persistent 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert Wood, MD, Study chair, Johns Hopkins Children's Center: Department of Allergy & ImmunologyEdward M. Zoratti, MD, Study chair, Henry Ford Health System: Division of Allergy and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541187
- Sponsor's protocol ID
- DAIT ICAC-28
- Other IDs
- UM1AI114271, NIAID CRMS ID#: 38517
- Acronym
- CRITICAL
- Status last verified
- May 2023
- First submitted
- 7 May 2018
- Last updated
- 22 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant level data access will be made available to the public at some point in the future via the mechanism of the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
Dunaway LE, Da Silva Antunes R, Pomes A, Altman MC, Glesner J, Benson B, Cho K, Zoratti EM, Wood RA, Little FF, Pongracic JA, Hershey GKK, Sherenian MG, Chambliss JM, Gill MA, Liu AH, Lamm C, Kattan M, Bacharier LB, Sheehan WJ, Busse P, Togias A, Wheatley LM, Becker PM, Visness CM, Busse WW, Sette A, Jackson DJ. Correlates of cockroach nasal challenge responsiveness among sensitized urban children with asthma. J Allergy Clin Immunol Glob. 2026 Mar 18;5(3):100684. doi: 10.1016/j.jacig.2026.100684. eCollection 2026 May.
PubMed 42006155da Silva Antunes R, Sutherland A, Abawi A, Frazier A, Pomes A, Glesner J, Slater JE, Mindaye ST, Cho K, Zhou G, Ozanne MV, Calatroni A, Visness CM, Altman MC, Wood RA, O'Connor GT, Pongracic JA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Gill M, Searing D, Liu AH, Zoratti E, Kattan M, Busse PJ, Sheehan W, Bacharier LB, Teach SJ, Wheatley LM, Togias A, Busse WW, Jackson DJ, Sette A. Cockroach immunotherapy modulates dominant T-cell responses independent of allergen extract content. J Allergy Clin Immunol. 2025 Nov;156(5):1303-1313. doi: 10.1016/j.jaci.2025.07.011. Epub 2025 Jul 24.
PubMed 40714043
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cockroach Immunotherapy in Children and Adolescents
- ClinicalTrials.gov ID
- NCT03541187
- Acronym / sponsor ID
- CRITICAL / DAIT ICAC-28
- Conditions
- Persistent Asthma
- Keywords
- cockroach, immunotherapy, inner city asthma, subcutaneous immunotherapy (SCIT), Nasal Allergen Challenge (NAC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium, Rho Federal Systems Division, Inc.
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Posted 22 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Scientific evidence has shown that, over the past two decades, 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 Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of cockroach immunotherapy in inner city asthma.
The primary objective of the study is to determine if the response to nasal allergen challenge (NAC) will be changed with treatment with cockroach subcutaneous immunotherapy (SCIT) treatment.
Detailed description
This is a 1:1 randomized, double-masked (blind), placebo-controlled, multicenter trial with 2 treatment arms:
- German Cockroach Subcutaneous Immunotherapy (SCIT) + guideline-based standard asthma care, OR
- Placebo (for German Cockroach Subcutaneous Immunotherapy [SCIT]) + guideline-based standard asthma care
Eighty participants 8 to 17 years of age who are sensitized to cockroach, have asthma, and a positive cockroach Nasal Allergen Challenge (NAC) before treatment randomization will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G. cockroach allergenic extract | Experimental | Biological: German cockroach allergenic extractSubcutaneous immunotherapy (SCIT): German cockroach allergenic extract. 40 participants 8 to 14 years of age will be randomized to this treatment arm. -Up to 2 doses of the assigned SCIT treatment will be given weekly during dose escalation, separated by a minimum of 2 days. After maintenance dose is achieved, participants will receive three maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. |
| Placebo | Placebo comparator | Biological: Placebo for German cockroach allergenic extractSubcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 14 years of age will be randomized to this treatment arm. -Up to 2 doses of the assigned SCIT treatment will be given weekly during dose escalation, separated by a minimum of 2 days. Once the maintenance dose is achieved, participants will receive three maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- And/or parent guardian must be able to understand and provide informed consent;
- Age at date of recruitment (e.g., screening): 8 to 17 years of age
- Have a primary place of residence in one of the pre-selected recruitment census tracts (Reference: Inner-City Asthma Consortium):
- --Note: Subjects who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly-funded health insurance will qualify for inclusion.
- Have a history of persistent asthma, for a minimum of 1 year before study entry:
Key exclusion criteria (28 listed)
- Unable or unwilling to give written informed consent or comply with the study protocol;
- That is pregnant or lactating;
- That are post-menarcheal females must be abstinent or use a medically acceptable birth control method throughout their participation in the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
- That cannot perform spirometry and peak flow at treatment randomization;
- That have an asthma severity classification at the time of treatment randomization of severe persistent, using the The National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
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 |
|---|---|---|
| German cockroach allergenic extractAlso: Blattella germanica allergenic extractActive ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467). | Biological | G. cockroach allergenic extract |
| Placebo for German cockroach allergenic extractAlso: Placebo for Blattella germanica allergenic extractCommercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). | Biological | Placebo |
Primary outcome
Change in Mean Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo
Time frame: After 12 months
The study's primary endpoint is the mean TNSS change from baseline to 12 months, calculated as the difference between baseline and 12-month mean TNSS up to baseline responsive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling mean TNSS difference with factors for treatment arm, site, and baseline mean TNSS. Least square means (LSmeans), SEs, difference in LSmeans between treatment and placebo groups, 95% CI, and p-value are reported. A greater change in the LSmeans indicates a better outcome.
5 secondary outcomes
Number of Immunotherapy Related Adverse Events and Number of Immunotherapy Related Serious Adverse Events in the Course of Treatment.
Time frame: After 12 months
Change in Area Under the Curve (AUC) Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo
Time frame: After 12 months
Change in 12-month Responsive Dose Between Cockroach SCIT and Placebo
Time frame: After 12 months
Change in Log-transformed German Cockroach-specific IgE From Baseline to 12 Months Between Cockroach SCIT and Placebo
Time frame: After 12 months
Change in Log-transformed German Cockroach-specific IgG4 From Baseline to 12 Months Between Cockroach SCIT and Placebo
Time frame: After 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42006155Dunaway LE, Da Silva Antunes R, Pomes A, Altman MC, Glesner J, Benson B, Cho K, Zoratti EM, Wood RA, Little FF, Pongracic JA, Hershey GKK, Sherenian MG, Chambliss JM, Gill MA, Liu AH, Lamm C, Kattan M, Bacharier LB, Sheehan WJ, Busse P, Togias A, Wheatley LM, Becker PM, Visness CM, Busse WW, Sette A, Jackson DJ. Correlates of cockroach nasal challenge responsiveness among sensitized urban children with asthma. J Allergy Clin Immunol Glob. 2026 Mar 18;5(3):100684. doi: 10.1016/j.jacig.2026.100684. eCollection 2026 May.
- Derived from this study: PubMed 40714043da Silva Antunes R, Sutherland A, Abawi A, Frazier A, Pomes A, Glesner J, Slater JE, Mindaye ST, Cho K, Zhou G, Ozanne MV, Calatroni A, Visness CM, Altman MC, Wood RA, O'Connor GT, Pongracic JA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Gill M, Searing D, Liu AH, Zoratti E, Kattan M, Busse PJ, Sheehan W, Bacharier LB, Teach SJ, Wheatley LM, Togias A, Busse WW, Jackson DJ, Sette A. Cockroach immunotherapy modulates dominant T-cell responses independent of allergen extract content. J Allergy Clin Immunol. 2025 Nov;156(5):1303-1313. doi: 10.1016/j.jaci.2025.07.011. Epub 2025 Jul 24.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Inner-City Asthma ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data access will be made available to the public at some point in the future via the mechanism of the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Related trials for Persistent Asthma
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Expression of TSLP Isoforms in Asthma
Asthma Atopic, Asthma Severe Persistent Uncontrolled
Not yet recruitingPhase 1
Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)
Asthma (Diagnosis), Persistent Asthma
Not yet recruiting
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Asthma, Asthma Chronic
RecruitingPhase 2
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
Allergic Asthma
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 Children's Center: Department of Allergy & Immunology
Edward M. Zoratti, MD study chair
Henry Ford Health System: Division of Allergy and Immunology
11 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 German cockroach allergenic extract in people with Persistent Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 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 16 inclusion and 28 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 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 22 May 2023). 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 Mean Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo (time frame: After 12 months). 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 NCT03541187, which also lists 2 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 22 May 2023.