Cockroach Nasal Allergen Challenge Pilot

NCT02710136 | Completed Phase 1 Results DMC

• 2 other identifiers: DAIT ICAC-27CoNAC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

This research is being done to look at the body's response to cockroach extract, an allergen, when sprayed into the nose. The spraying of the cockroach extract into the participant's nose is called Nasal Allergen Challenge (NAC). The purpose of this study is to evaluate the safety and tolerability of a intranasal cockroach extract given to participants with asthma.

Conditions

Asthma; Cockroach Hypersensitivity

Keywords

Asthma; Glycerinated German cockroach allergenic extract; Cockroach Nasal Allergen Challenge

Outcome Measures

Primary Outcomes (1)

• Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)

  Result is the proportion of participants (Pss) responding at each of 9 CA doses during the NAC.To illustrate the variability of the outcome at each dose,the protocol specifies computation of 95% CIs for the proportion responding at each dose.A proportion is to record for each Ps a 0 for non-responder and 1 for responder \&compute the mean of the 0 \&1 values.Summary statistic for this method: a mean. After each dose,TNSS \&TNSS Sneezing scores were recorded.TNSS (0-12) is a self-rated score computed as the sum of 4 subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, \& itchy nose symptoms (sxs).Pss provide a score on each subscale of 0, 1, 2, or 3(none, mild, moderate, or severe sxs, respectively).Pss cont'd receiving doses until either a TNSS (≥8 in adults,≥6 in children) or sneezing score threshold \[TLV\] of 3 was met.Assumption: Pss met TLV criteria for doses not recv'd beyond dose at which TLV criteria were initially met.

  NAC Baseline through last dose of German cockroach allergen administered during the NAC

Secondary Outcomes (8)

• Number of Sneezes at Each of Nine Doses of German Cockroach Allergen

  NAC Baseline through last dose of German cockroach allergen administered during the NAC

• Highest Total Nasal Symptom Score (TNSS)

  NAC Baseline through last dose of German cockroach allergen administered during the NAC

• Change in Total Nasal Symptom Score (TNSS)

  NAC Baseline through last dose of German cockroach allergen administered during the NAC

• Change in Peak Nasal Inspiratory Flow (PNIF) L/Min

  NAC Baseline through last dose of German cockroach allergen administered during the NAC

• Change in Peak Expiratory Flow (PEF) L/Min

  NAC Baseline through last dose of German cockroach allergen administered during the NAC

Study Arms (1)

Glycerinated CR Allergenic Extract

EXPERIMENTAL

Complete Arm Title: Glycerinated German Cockroach Allergenic Extract. Cockroach sensitive subjects are exposed to cockroach nasal allergen (NAC) intranasally at at increasing doses per protocol. The NAC aim is pursuit of optimal dose range as determined by tolerability and eliciting a threshold of nasal symptoms.

Biological: Glycerinated German Cockroach Allergenic Extract

Interventions

Glycerinated German Cockroach Allergenic Extract BIOLOGICAL

Participants will receive escalating doses intranasally. Briefly: per protocol- Phase 1a NAC: N=10 cockroach sensitive adults with asthma will undergo nasal allergen challenge with dose escalation (up to 8 doses per protocol). Phase 1b: Phase 1a subjects will have repeat NAC with dose escalation (up to 8 doses). Phase 2: N=25 cockroach sensitive children with asthma (ages 8 - 14 years) will undergo NAC with doses determined by Phase 1a data (e.g., symptoms and safety data).

Also known as: Blattella germanica allergenic extract, Cockroach antigen (CR antigen)

Glycerinated CR Allergenic Extract

Eligibility Criteria

• Age: 8 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects fulfilling all of the following criteria are eligible for enrollment as study participants for Phase 1a and Phase 2:
• Subject and/or parent guardian must be able to understand and provide informed consent.
• Male or female adults, 18 through 55 years of age at recruitment (Phase 1) or male or female children, 8-14 years of age at recruitment (Phase 2).
• Have a history of asthma for a minimum of 1 year before study entry:
• A diagnosis of asthma for this study is defined as a reported clinical diagnosis of asthma made by a physician over a year ago.
• The subject must have persistent asthma defined by the current need for at least 100 microgram (mcg) fluticasone per day or the equivalent of another inhaled corticosteroid.
• The subject's asthma must be well controlled as defined by:
• A Forced Expiratory Volume in 1 Second (FEV1) ≥ 80% predicted.
• An Asthma Control Test (ACT) score ≥ 20.
• Are sensitive to German Cockroach as documented by a positive (≥ 3 mm greater than negative control) skin prick test result and a positive German Cockroach specific immunoglobulin E (IgE) (≥0.35 kUA/L).
• Have no known contraindications to the allergenic extracts or diluents.
• Subjects who meet the following criteria are eligible for enrollment as study participants in Phase 1b after completion of Phase 1a:
• Their asthma must be well controlled as defined by:
• A FEV1 ≥ 80% predicted.
• An Asthma Control Test (ACT) score ≥ 20.

You may not qualify if:

• Subjects fulfilling any of the following criteria are not eligible for enrollment in any portion of the study and may not be reassessed. Participants are ineligible if they:
• Plan to move from the area during the study period.
• Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined by the grading scale of Brown et al. for anaphylaxis and systemic reactions to study procedures.
• 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 (both oral and topical).
• Subjects who meet any of these criteria are not eligible for enrollment as study participants in Phase1a and Phase 2:
• Are pregnant or lactating. Post-menarcheal females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception).
• Cannot perform spirometry at Screening.
• Have an asthma severity classification at Recruitment of severe persistent, using the The National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
• Require a dose of greater than 500mcg 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 or one course within the last 3 months.
• Have been treated with depot corticosteroids within the last 12 months.
• Have been hospitalized for asthma within the 12 months prior to recruitment.
• Have had an emergency room visit for asthma within the 3 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.

Sponsors & Collaborators

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

Study Sites (4)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Rudman Spergel AK, Sever ML, Johnson J, Gill MA, Schulten V, Frazier A, Kercsmar CM, Lovinsky-Desir S, Searing DA, Sette A, Shao B, Teach SJ, Gern JE, Busse WW, Togias A, Wood RA, Liu AH; National Institute of Allergy and Infectious Diseases Inner City Asthma Consortium. Development of nasal allergen challenge with cockroach in children with asthma. Pediatr Allergy Immunol. 2021 Jul;32(5):971-979. doi: 10.1111/pai.13480. Epub 2021 Mar 20.

  PMID: 33606312 DERIVED

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: 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: March 7, 2016
• First Posted: March 16, 2016
• Study Start: February 1, 2016
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: September 25, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: The aim is to share data available to the public within 24 months upon completion of the study.
• Access Criteria: ImmPort public data access.

Locations

US (4)