Cockroach Immunotherapy in Children and Adolescents

NCT ID: NCT03541187

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2022-06-03

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

German cockroach allergenic extract

Intervention Type: BIOLOGICAL

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo for German cockroach allergenic extract

Intervention Type: BIOLOGICAL

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

Interventions

German 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).

Intervention Type: BIOLOGICAL

Placebo for German cockroach allergenic extract

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Blattella germanica allergenic extract; Placebo for Blattella germanica allergenic extract

Eligibility Criteria

Inclusion Criteria

• 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

• 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).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inner-City Asthma Consortium

NETWORK

Sponsor Role: collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Wood, MD

Role: STUDY_CHAIR

Johns Hopkins Children's Center: Department of Allergy & Immunology

Edward M. Zoratti, MD

Role: STUDY_CHAIR

Henry Ford Health System: Division of Allergy and Immunology

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center - IMPACT DC

Washington D.C., District of Columbia, United States

Ann and Robert Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Henry Ford Health System: Division of Allergy and Immunology

Detroit, Michigan, United States

St. Louis Children's Hospital: Allergy, Immunology and Pulmonary Medicine Program

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

University of Texas Southwestern Medical School

Dallas, Texas, United States

Countries

United States

References

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 Jul 24:S0091-6749(25)00798-5. doi: 10.1016/j.jaci.2025.07.011. Online ahead of print.

Reference Type: DERIVED

PMID: 40714043 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT)

https://www.niaid.nih.gov/clinical-trials/inner-city-asthma-consortium

Inner-City Asthma Consortium

Other Identifiers

UM1AI114271

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAID CRMS ID#: 38517

Identifier Type: OTHER

Identifier Source: secondary_id

DAIT ICAC-28

Identifier Type: -

Identifier Source: org_study_id