Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium

NCT01221285 | Completed Phase 1 Results DMC

• 2 other identifiers: DAIT ICAC-18SCITCO
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Perennial Allergic Rhinitis

Keywords

Cockroach; Immunotherapy; Subcutaneous immunotherapy; Inner city asthma

Outcome Measures

Primary Outcomes (2)

• Number of Reported Treatment-related Adverse Events (AEs)

  Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.

  Baseline through 6-months of treatment

• Number of Reported Treatment-related Serious Adverse Events (SAEs)

  Number of SAEs reported as possibly related, probably related, or definitely related to study participation.

  Baseline through 6-months of treatment

Secondary Outcomes (4)

• Change in German Cockroach-Specific Serum IgE Over Time

  Baseline through 6-months of treatment

• Change in German Cockroach-Specific Serum IgG Over Time

  Baseline through 6-months of treatment

• Change in German Cockroach-Specific Serum IgG4 Over Time

  Baseline through 6-months of treatment

• Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract)

  Baseline through 6-months of treatment

Study Arms (1)

German cockroach allergenic extract

EXPERIMENTAL

Participants will receive weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.

Biological: German cockroach (Blattella germanica) allergenic extract

Interventions

German cockroach (Blattella germanica) allergenic extract BIOLOGICAL

Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.

German cockroach allergenic extract

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Inner-City Asthma Consortium: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 24184147 RESULT

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Associate Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Robert Wood, MD

  Johns Hopkins University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 11, 2014
• Results First Posted: May 23, 2014

Record last verified: 2014-06

Locations

US (1)