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CompletedNCT03541187CRITICALUpdated May 22, 2023Results posted

Cockroach Immunotherapy in Children and Adolescents

A Phase 2 interventional study of German cockroach allergenic extract and Placebo for German cockroach allergenic extract in Persistent Asthma, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 11 sites in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-05-22.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
8 Years to 17 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Persistent Asthma

Keywords

  • cockroach
  • immunotherapy
  • inner city asthma
  • subcutaneous immunotherapy (SCIT)
  • Nasal Allergen Challenge (NAC)
03

In context

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.

Browse National Institute of Allergy and Infectious Diseases (NIAID) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:Subject(s)

  • 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
    • 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.

Exclusion Criteria:Subject(s)

  • 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,
    • 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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    G. cockroach allergenic extract

    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.

    Biological: German cockroach allergenic extract

  • Placebo comparator
    Placebo

    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.

    Biological: Placebo for German cockroach allergenic extract

Interventions

  • BiologicalGerman cockroach 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).

    Also known as: Blattella germanica allergenic extract

  • BiologicalPlacebo for German cockroach allergenic extract

    Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%).

    Also known as: Placebo for Blattella germanica allergenic extract

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: After 12 months

Secondary outcomes

  1. 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.

    Time frame: After 12 months

  2. 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.

    Time frame: After 12 months

  3. 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.

    Time frame: After 12 months

  4. 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.

    Time frame: After 12 months

  5. 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.

    Time frame: After 12 months

Other outcomes

  1. EXPLORATORY: Composite Asthma Severity Score (CASI)-by Treatment Group

    The Composite Asthma Severity Index (CASI) is a comprehensive severity scale combining multiple facets of asthma severity: impairment, risk, and treatment. The CASI score ranges from 0 to 20 points, with higher scores indicating higher levels of severity, and includes 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations.

    Time frame: Month 10, Month 12

  2. EXPLORATORY: Number of Days With Asthma Symptoms-by Treatment Group

    Defined by the presence of wheezing or tightness in the chest, or cough.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  3. EXPLORATORY: Number of Nights With Asthma Symptoms-by Treatment Group

    Defined by participant waking up during the night due to the presence of wheezing or tightness in the chest, or cough.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  4. EXPLORATORY: Number of Days With Albuterol Use-by Treatment Group

    Albuterol is a bronchodilator used for asthma control.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  5. EXPLORATORY: Number of Nights With Albuterol use-by Treatment Group

    Albuterol is a bronchodilator used for asthma control.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  6. EXPLORATORY: Asthma Treatment step-by Treatment Group

    Defined by medication requirements for asthma control.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  7. EXPLORATORY: Number of Asthma exacerbations-by Treatment Group

    Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the study.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  8. EXPLORATORY: Spirometry Measurement: Forced Expiratory Volume in 1 Second (FEV1)-by Treatment Group

    FEV1 is air volume exhaled in 1 second during spirometry and is a measure of asthma severity.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  9. EXPLORATORY: Comparison of Rhinitis Symptom severity-by Treatment Group

    Measured using the Modified Rhinitis Symptom Utility Index.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  10. EXPLORATORY: Comparison of Rhinitis Treatment step-by Treatment Group

    Defined by medication requirements for rhinitis control.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  11. EXPLORATORY: Change in German Cockroach-Specific Serum IgG Over Time-by Treatment Group

    Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  12. EXPLORATORY: Change in German Cockroach-Specific Component Allergens Over time-by Treatment Group

    Including but not limited to the following component allergens: Bla g 1, Bla g 2, Bla g 4, Bla g 5 and Per a 7.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  13. EXPLORATORY: Change in Cockroach Skin Test Reactivity Over Time-by Treatment Group

    As a measure of response to cockroach immunotherapy.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  14. EXPLORATORY: Change in Cockroach-Specific Blocking Antibodies Over Time-by Treatment Group

    To explore serum measurement(s) of in-vitro cockroach antigen binding to B-cells.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  15. EXPLORATORY: Change in Cockroach-Specific T Cell Response-by Treatment Group

    Limited to Part A only: Peripheral blood mononuclear cells (PBMCs) will be evaluated for the magnitude and phenotype of the Cockroach (CR)-specific T cell response to CR immunotherapy.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  16. EXPLORATORY: Change in Peripheral Blood Mononuclear Cells (PBMCs) Gene Expression Response to Cockroach (CR) Stimulation Over Time-by Treatment Group

    To identify the changes in PBMC gene expression response to cockroach stimulation over time and compare those changes between the treated (German cockroach allergenic extract ) and untreated (placebo) group.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

  17. EXPLORATORY: Change in Nasal Lavage Gene Expression Over Time-by Treatment Group

    To identify the changes in nasal lavage gene expression response to cockroach stimulation over time and compare those changes between the treated (German cockroach allergenic extract ) and untreated (placebo) group.

    Time frame: Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

07

Results

Posted May 22, 2023

Participant flow

Recruited 308 participants with the goal of enrolling 80 participants into this trial. Each participant received a 12 month treatment.

Participant flow — Overall Study
MilestoneCockroach SCITPlacebo
Started4042
Completed2829
Not completed1213
Withdrew: Lost to follow-up26
Withdrew: Pregnancy01
Withdrew: Withdrawal by subject62
Withdrew: Moved out of town10
Withdrew: >2 bursts of systemic corticosteroids for asthma during treatment period (starting nov 2020)12
Withdrew: Did not meet randomization criteria11
Withdrew: Potential inability to tolerate maintenance dose10
Withdrew: Need for dose >500 mcg of fluticasone for 6 months01

Outcome measures

PrimaryChange 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.

Time frame:
After 12 months
Reported as:
Least squares mean · score on a scale
Change in Mean Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo
score on a scaleCockroach SCITPlacebo
Change in Mean Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo-1.02 ± 0.37-0.79 ± 0.35
Statistical analysis
  • Cockroach SCIT vs Placebo · ANCOVA · p = 0.63 · Least square mean difference: -0.23 · 95% CI -1.15 to 0.70
SecondaryNumber 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.

Time frame:
After 12 months
Reported as:
Number · Adverse Events
Number of Immunotherapy Related Adverse Events and Number of Immunotherapy Related Serious Adverse Events in the Course of Treatment.
Adverse EventsCockroach SCITPlacebo
Number of Immunotherapy Related Adverse Events13036
Number of Immunotherapy Related Serious Adverse Events00
SecondaryChange 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.

Time frame:
After 12 months
Reported as:
Least squares mean · score on a scale
Change in Area Under the Curve (AUC) Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo
score on a scaleCockroach SCITPlacebo
Change in Area Under the Curve (AUC) Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo-0.65 ± 0.33-0.48 ± 0.31
Statistical analysis
  • Cockroach SCIT vs Placebo · ANCOVA · p = 0.69 · Least square means difference: -0.17 · 95% CI -0.99 to 0.66
SecondaryChange 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.

Time frame:
After 12 months
Reported as:
Count of participants · Participants
Change in 12-month Responsive Dose Between Cockroach SCIT and Placebo
ParticipantsCockroach SCITPlacebo
Reactive Dose 1 at 12 Months - 0 mcg/mL20
Reactive Dose 2 at 12 Months -0.00492 mcg/mL10
Reactive Dose 3 at 12 Months - 0.0155mcg/mL13
Reactive Dose 4 at 12 Months - 0.0490 mcg/mL31
Reactive Dose 5 at 12 Months - 0.155 mcg/mL14
Reactive Dose 6 at 12 Months - 0.489 mcg/mL41
Reactive Dose 7 at 12 Months - 1.54mcg/mL17
Reactive Dose 8 at 12 Months - 4.88 mcg/mL13
Reactive Dose 9 at 12 Months - 15.4 mcg/mL1410
Statistical analysis
  • Cockroach SCIT vs Placebo · Regression, Cox · p = .51 · Hazard ratio (hr): 0.81 · 95% CI 0.42 to 1.54At the reactive dose of 15.4 mcg/mL after 12 months, there were 11 participants who were right-censored in the Cockroach SCIT arm and 8 participants who were right-censored in the Placebo arm.
SecondaryChange 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.

Time frame:
After 12 months
Reported as:
Least squares mean · Log(kuA/L)
Change in Log-transformed German Cockroach-specific IgE From Baseline to 12 Months Between Cockroach SCIT and Placebo
Log(kuA/L)Cockroach SCITPlacebo
Change in Log-transformed German Cockroach-specific IgE From Baseline to 12 Months Between Cockroach SCIT and Placebo-0.56 ± 0.20-0.53 ± 0.19
Statistical analysis
  • Cockroach SCIT vs Placebo · ANCOVA · p = 0.91 · Least square means difference: -0.03 · 95% CI -0.54 to 0.49
SecondaryChange 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.

Time frame:
After 12 months
Reported as:
Least squares mean · Log(ng/mL)
Change in Log-transformed German Cockroach-specific IgG4 From Baseline to 12 Months Between Cockroach SCIT and Placebo
Log(ng/mL)Cockroach SCITPlacebo
Change in Log-transformed German Cockroach-specific IgG4 From Baseline to 12 Months Between Cockroach SCIT and Placebo-1.58 ± 0.22-6.90 ± 0.21
Statistical analysis
  • Cockroach SCIT vs Placebo · ANCOVA · p = <0.001 · Least square means difference: 5.32 · 95% CI 4.77 to 5.87
Other pre-specifiedEXPLORATORY: Composite Asthma Severity Score (CASI)-by Treatment Group

The Composite Asthma Severity Index (CASI) is a comprehensive severity scale combining multiple facets of asthma severity: impairment, risk, and treatment. The CASI score ranges from 0 to 20 points, with higher scores indicating higher levels of severity, and includes 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations.

Time frame:
Month 10, Month 12

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Number of Days With Asthma Symptoms-by Treatment Group

Defined by the presence of wheezing or tightness in the chest, or cough.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Number of Nights With Asthma Symptoms-by Treatment Group

Defined by participant waking up during the night due to the presence of wheezing or tightness in the chest, or cough.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Number of Days With Albuterol Use-by Treatment Group

Albuterol is a bronchodilator used for asthma control.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Number of Nights With Albuterol use-by Treatment Group

Albuterol is a bronchodilator used for asthma control.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Asthma Treatment step-by Treatment Group

Defined by medication requirements for asthma control.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Number of Asthma exacerbations-by Treatment Group

Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the study.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Spirometry Measurement: Forced Expiratory Volume in 1 Second (FEV1)-by Treatment Group

FEV1 is air volume exhaled in 1 second during spirometry and is a measure of asthma severity.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Comparison of Rhinitis Symptom severity-by Treatment Group

Measured using the Modified Rhinitis Symptom Utility Index.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Comparison of Rhinitis Treatment step-by Treatment Group

Defined by medication requirements for rhinitis control.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Change in German Cockroach-Specific Serum IgG Over Time-by Treatment Group

Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Change in German Cockroach-Specific Component Allergens Over time-by Treatment Group

Including but not limited to the following component allergens: Bla g 1, Bla g 2, Bla g 4, Bla g 5 and Per a 7.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Change in Cockroach Skin Test Reactivity Over Time-by Treatment Group

As a measure of response to cockroach immunotherapy.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Change in Cockroach-Specific Blocking Antibodies Over Time-by Treatment Group

To explore serum measurement(s) of in-vitro cockroach antigen binding to B-cells.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Change in Cockroach-Specific T Cell Response-by Treatment Group

Limited to Part A only: Peripheral blood mononuclear cells (PBMCs) will be evaluated for the magnitude and phenotype of the Cockroach (CR)-specific T cell response to CR immunotherapy.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Change in Peripheral Blood Mononuclear Cells (PBMCs) Gene Expression Response to Cockroach (CR) Stimulation Over Time-by Treatment Group

To identify the changes in PBMC gene expression response to cockroach stimulation over time and compare those changes between the treated (German cockroach allergenic extract ) and untreated (placebo) group.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Other pre-specifiedEXPLORATORY: Change in Nasal Lavage Gene Expression Over Time-by Treatment Group

To identify the changes in nasal lavage gene expression response to cockroach stimulation over time and compare those changes between the treated (German cockroach allergenic extract ) and untreated (placebo) group.

Time frame:
Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Results for this outcome have not been posted.

Adverse events

Collected over Adverse events (including SAEs) were collected from the time of obtaining informed consent until 30 days after a participant completed study participation or until 30 days after the participant prematurely withdrew or was withdrawn from the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cockroach SCIT0/40 (0%)2/40 (5%)34/40 (85%)
Placebo0/42 (0%)0/42 (0%)35/42 (83.3%)
Most frequent serious events
Most frequent serious events
EventCockroach SCITPlacebo
Suicidal ideationPsychiatric disorders1/400/42
Suicide attemptPsychiatric disorders1/400/42
Most frequent other events
Showing 10 of 33
Most frequent other events
EventCockroach SCITPlacebo
Injection site reactionGeneral disorders18/403/42
Injection site erythemaGeneral disorders11/404/42
HeadacheNervous system disorders10/407/42
Upper respiratory tract infectionInfections and infestations6/4010/42
HypersensitivityImmune system disorders5/407/42
Peak expiratory flow rate decreasedInvestigations4/406/42
Anaphylactic reactionImmune system disorders5/402/42
UrticariaSkin and subcutaneous tissue disorders5/404/42
Viral infectionInfections and infestations2/405/42
PruritusSkin and subcutaneous tissue disorders2/405/42

Baseline characteristics

Intent-to-treat population with available data

Age, Continuous
Age, Continuous(years)Cockroach SCITPlaceboTotal
Mean12.1 ± 2.4812.2 ± 2.4912.1 ± 2.46
Age, Customized
Age, Customized(Participants)Cockroach SCITPlaceboTotal
Between 8 and 11 years121123
≥ 12 years161834
Sex: Female, Male
Sex: Female, Male(Participants)Cockroach SCITPlaceboTotal
Female121426
Male161531
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cockroach SCITPlaceboTotal
American Indian or Alaska Native011
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American211637
White257
More than one race336
Unknown or Not Reported246
Region of Enrollment
Region of Enrollment(participants)Cockroach SCITPlaceboTotal
United States282957
Caretaker completed high school
Caretaker completed high school(Participants)Cockroach SCITPlaceboTotal
Yes232346
No5611
Annual household income (<15k)
Annual household income (<15k)(Participants)Cockroach SCITPlaceboTotal
Yes121628
No151328
Dont Know101
Cockroach-specific IgE at Baseline
Cockroach-specific IgE at Baseline(kUA/L)Cockroach SCITPlaceboTotal
Median7.9 (2.4 to 49.2)2.6 (0.8 to 12.3)4.6 (1.5 to 35.2)

2 further baseline measures are reported on the registry.

08

Study locations

11 sites
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • Children's National Medical Center - IMPACT DC
    Washington D.C., District of Columbia 20010, United States
  • Ann and Robert Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Henry Ford Health System: Division of Allergy and Immunology
    Detroit, Michigan 48202, United States
  • St. Louis Children's Hospital: Allergy, Immunology and Pulmonary Medicine Program
    St Louis, Missouri 63110, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Cincinnati Children's Hospital
    Cincinnati, Ohio 45229-3039, United States
  • University of Texas Southwestern Medical School
    Dallas, Texas 75390-8859, United States
09

References and documents

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 42006155 ↗
  • da 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 documents

  • Study protocol · Jan 11, 2021
  • Statistical analysis plan · Jun 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Time frame: The aim is to share data with the public within 24 months upon completion of the study.

Access criteria: ImmPort public data access.

Data sharing details ↗ · www.immport.org

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03541187
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Inner-City Asthma Consortium, Rho Federal Systems Division, Inc.
Responsible party
Sponsor
First posted
May 30, 2018
Start date
Jul 16, 2018
Primary completion
Jun 2, 2022
Completion
Jun 3, 2022
Results posted
May 22, 2023
Last update
May 22, 2023

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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