Purpose

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 asthma severity can be improved by cockroach subcutaneous immunotherapy (SCIT) treatment.

Condition

Eligibility

Eligible Ages
Between 6 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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):

- in Part A: 8 to 17 years of age

- in Part B: 6 to 16 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.

- Has a history of persistent asthma, for a minimum of 1 year before study entry:

- 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).

- Has no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo;

- In Part A only: Subject must 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 at screening; 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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
G. cockroach allergenic extract - Part A
Subcutaneous immunotherapy (SCIT): German cockroach allergenic extract. 40 participants 8 to 14 years of age will be randomized to this treatment arm. An interim analysis will be conducted when all Part A participants have completed their 12-month NAC. If an effect is seen for the Part A NAC analysis, the study will proceed to Part B. -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 24 months and up to a maximum of 36 months.
  • Biological: 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).
    Other names:
    • Blattella germanica allergenic extract
Placebo Comparator
Placebo- Part A
Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 14 years of age will be randomized to this treatment arm. An interim analysis will be conducted when all Part A participants have completed their 12-month NAC. If an effect is seen for the Part A NAC analysis, the study will proceed to Part B. -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 24 months and up to a maximum of 36 months.
  • 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%).
    Other names:
    • Placebo for Blattella germanica allergenic extract
Experimental
G. cockroach allergenic extract-Part B
Subcutaneous immunotherapy (SCIT): German cockroach allergenic extract. 110 participants 6 to 16 years of age who are sensitized to cockroach and have asthma will be randomized to this treatment arm. In contrast to Part A, a positive NAC will not be required for inclusion into Part B treatment. -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 24 months and up to a maximum of 36 months.
  • Biological: 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).
    Other names:
    • Blattella germanica allergenic extract
Placebo Comparator
Placebo- Part B
Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 110 participants 6 to 16 years of age who are sensitized to cockroach and have asthma will be randomized to this treatment arm. In contrast to Part A treatment, a positive NAC will not be required for inclusion into Part B treatment. -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 24 months and up to a maximum of 36 months.
  • 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%).
    Other names:
    • Placebo for Blattella germanica allergenic extract

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center - IMPACT DC
Washington, District of Columbia 20010
Contact:
Alicia Newcomer
202-476-4698
anewcome@childrensnational.org

More Details

NCT ID
NCT03541187
Status
Recruiting
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

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

The study will occur in two parts - Part A and Part B:

- Part A will enroll 80 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.

An interim analysis will be conducted when all Part A participants have completed their 12-month NAC. If an effect is seen for the Part A NAC analysis, the study will proceed to Part B.

-Part B will enroll 220 participants 6 to 16 years of age, who are sensitized to cockroach and have asthma. A positive NAC will not be required for inclusion into Part B.

The study will be based on a continuous treatment schedule with German cockroach allergenic extract or placebo, up to a maximum of 36 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.