Clinical trial NCT01221285: Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium
Official title: A Biomarker-Based Pilot Study of Cockroach Subcutaneous Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-18)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Perennial Allergic Rhinitis
Keywords: Cockroach
Immunotherapy
Subcutaneous immunotherapy
Inner city asthma
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Inner-City Asthma Consortium
First posted: 2010-10-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a biomarker-based pilot study of the safety of Cockroach Subcutaneous Immunotherapy in Cockroach-sensitive Adults (SCITCO) who have a history of perennial allergic rhinitis, asthma, or both.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Have a history of perennial allergic rhinitis, asthma, or both, for a minimum of 1 year before study entry. For those with asthma:

  * a diagnosis of asthma will be defined as a report by the participant that they have had a clinical diagnosis of asthma made by a physician over a year ago
  * the participant's asthma must be well controlled as defined by:
  * a forced expiratory volume at one second (FEV1) greater than or equal to 80% predicted value with or without controller medication
  * albuterol use for no more than 3 days per week in each of the previous 2 weeks for asthma symptoms (not including exercise prophylaxis)
* Are sensitive to German cockroach (Blattella germanica) as documented by a positive (\>= 3 mm greater than negative control) skin prick test result and detectable German cockroach specific IgE (\>=0.35 kUA/L)
* Have no known contraindications to therapy with glycerinated German (Blattella germanica) cockroach allergenic extract
* Are willing to sign the written Informed Consent prior to initiation of any study procedure

Exclusion Criteria:

* Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception)
* Are unable to perform spirometry at screening
* Have an asthma severity classification at recruitment of severe persistent, using the National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:

  * requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid
  * have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months
  * have been treated with depot steroids within the last 12 months
  * have been hospitalized for asthma within the 6 months prior to recruitment
  * have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment
* Do not have access to a phone (needed for scheduling appointments)
* Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study. Subjects who only received placebo therapy in the BioCSI protocol (A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis, ICAC-12, NCT00829985) are eligible to participate in this study
* Have previously been treated with anti-IgE therapy within 1 year of recruitment
* Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study
* Refuse to sign the Epinephrine Auto-injector Training Form
* Do not primarily speak English
* Plan to move from the area during the study period
* Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined in the protocol
* Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the participant
* Are using tricyclic antidepressants or beta-adrenergic blocker drugs (either oral or topical route\[s\] of administration)

Primary outcomes:
measure: Number of Reported Treatment-related Adverse Events (AEs)
timeFrame: Baseline through 6-months of treatment
measure: Number of Reported Treatment-related Serious Adverse Events (SAEs)
timeFrame: Baseline through 6-months of treatment
Secondary outcomes:
measure: Change in German Cockroach-Specific Serum IgE Over Time
timeFrame: Baseline through 6-months of treatment
measure: Change in German Cockroach-Specific Serum IgG Over Time
timeFrame: Baseline through 6-months of treatment
measure: Change in German Cockroach-Specific Serum IgG4 Over Time
timeFrame: Baseline through 6-months of treatment
measure: Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract)
timeFrame: Baseline through 6-months of treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert Wood, MD
role: STUDY_CHAIR
References:
citation: Wood RA, Togias A, Wildfire J, Visness CM, Matsui EC, Gruchalla R, Hershey G, Liu AH, O'Connor GT, Pongracic JA, Zoratti E, Little F, Granada M, Kennedy S, Durham SR, Shamji MH, Busse WW. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52.e6. doi: 10.1016/j.jaci.2013.08.047. Epub 2013 Nov 1.