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Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma (SCSS)

Primary Purpose

Allergy, Asthma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glycerinated German cockroach allergenic extract
Placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring Perennial Allergic Rhinitis, Asthma, Sublingual Immunotherapy (SLIT)

Eligibility Criteria

5 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for All Participants:

  • History of perennial allergic rhinitis with or without asthma for a minimum of 1 year prior to study entry
  • Positive skin prick test to German cockroach performed along with negative (saline) and positive (histamine) controls
  • Willing to sign EpiPen training form
  • Parent or guardian willing to provide informed consent, if applicable

Inclusion Criteria for Participants with Asthma:

  • Diagnosis of well-controlled, mild to moderate persistent asthma, defined as having symptoms at least 3 times a week with no controller medication OR less than 3 times a week on controller medication. More information about this criterion can be found in the protocol.
  • Diagnosis of asthma made over 1 year prior to study entry

Exclusion Criteria:

  • Have severe, persistent asthma (according to National Asthma Education and Prevention Program [NAEPP] classification) as evidenced by those who require a dose of greater than 500 mcg of fluticasone/day or equivalent of another inhaled corticosteroid OR who have been hospitalized for asthma within 6 months prior to study entry
  • Life-threatening asthma exacerbation requiring intubation or mechanical ventilation or resulting in a hypoxic seizure in the 2 years prior to study entry
  • History of anaphylaxis of Grade 2 or higher as defined in the protocol
  • Unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunologic diseases that, in the opinion of the investigator, may interfere with the study or pose additional risk to the patient. More information about this criterion can be found in the protocol.
  • Taking medications that could induce gastrointestinal reactions during the study. Participants taking such medications must prove to be stable with no side effects for at least 3 months prior to study screening to be considered eligible.
  • Received an investigational drug in the 30 days prior to study entry OR plan to receive an investigational drug during the study
  • Received allergen immunotherapy in the 180 days prior to screening or plan to initiate or resume allergen immunotherapy during the study
  • Taking tricyclic antidepressants or beta-adrenergic blocker drugs
  • Received omalizumab in the 3 months prior to study screening
  • Known contraindication to therapy with cockroach extract used in this study
  • Mental illness that would interfere with the participant's ability to comply to study requirements
  • History of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the study
  • Plan to leave study area during the study
  • Does not primarily speak English, including caretakers of participants when the participant is a child
  • Cannot perform spirometry
  • Pregnant or breastfeeding

Sites / Locations

  • Johns Hopkins University School of Medicine, 600 North Wolfe St, CMSC 1102

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

German Cockroach Allergen Dosing Group

Arm Description

Glycerinated German Cockroach Allergenic Extract

Outcomes

Primary Outcome Measures

Proportion of Participants Who Discontinue Study
Proportion of participants who discontinued study for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment)

Secondary Outcome Measures

Full Information

First Posted
February 12, 2007
Last Updated
June 5, 2015
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Inner-City Asthma Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT00434421
Brief Title
Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma
Acronym
SCSS
Official Title
A Safety and Pilot Dosing Study for Sublingual-Oral Administration of Glycerinated German Cockroach Allergenic Extract in Pediatric and Adult Subjects With Cockroach Allergy and Perennial Allergic Rhinitis With or Without Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Inner-City Asthma Consortium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.
Detailed Description
The prevalence of asthma has dramatically increased in many parts of the world. Currently, there is no effective way to prevent development of allergic rhinitis and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. However, detailed research of this approach is limited. The purpose of this study is to evaluate the safety and tolerability of a sublingual cockroach extract given to people with perennial allergic rhinitis. Participants in this study will include people both with and without asthma. Participation in this study will last a little more than 2 weeks. Participants will be stratified by age (oldest to youngest age group) and degree of cockroach sensitivity. Each age group will be enrolled after the previous group's safety data have been reviewed. At study entry (Day 0), participants will receive a dose of placebo and then up to seven incremental doses of cockroach extract at 15-minute intervals while observed by the clinic nurse. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached. At the Principal Investigator's discretion, participants who were able to achieve the maximum study dose will be invited to continue onto the 2-week treatment course of the study. These participants will return on Days 1 and 2 to the clinic to self-administer the maximum study dose of cockroach extract. After self-administering the maximum study dose, participants will be observed by the clinic nurse for 30 minutes. On Days 3 through 14, participants will take the maximum study dose of cockroach extract daily at home. Participants will be asked to keep a diary and record signs or symptoms experienced after taking each dose. Skin tests, breathing tests, and blood collection will occur at study screening. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical exam/fitness assessment will be done at study screening, study entry, and the final visit. Unused extract will be collected at the final visit from participants who entered the 2-week treatment course of the study. The reference for this study is SCSS (Sublingual Cockroach Safety Study) in the provided citation: Wood RA, Togias A, Wildfire J et al. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52. PubMed ID: 24184147).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Asthma
Keywords
Perennial Allergic Rhinitis, Asthma, Sublingual Immunotherapy (SLIT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
German Cockroach Allergen Dosing Group
Arm Type
Experimental
Arm Description
Glycerinated German Cockroach Allergenic Extract
Intervention Type
Drug
Intervention Name(s)
Glycerinated German cockroach allergenic extract
Other Intervention Name(s)
Blattella germanica allergenic extract, Cockroach antigen (CR antigen)
Intervention Description
Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Glycerinated German cockroach allergenic extract placebo
Intervention Description
Placebo was administered only as the first dose (e.g., representing no Glycerinated German Cockroach bioequivalent allergy units) during the initial 1-day, 8-dose escalation, otherwise referred to as the Preliminary Dosing Visit. Refer to the Glycerinated German cockroach allergenic extract treatment for more details. Route of administration: sublingual-oral route.
Primary Outcome Measure Information:
Title
Proportion of Participants Who Discontinue Study
Description
Proportion of participants who discontinued study for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment)
Time Frame
Initial placebo dose to end of 2-week treatment course (maximum study dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for All Participants: History of perennial allergic rhinitis with or without asthma for a minimum of 1 year prior to study entry Positive skin prick test to German cockroach performed along with negative (saline) and positive (histamine) controls Willing to sign EpiPen training form Parent or guardian willing to provide informed consent, if applicable Inclusion Criteria for Participants with Asthma: Diagnosis of well-controlled, mild to moderate persistent asthma, defined as having symptoms at least 3 times a week with no controller medication OR less than 3 times a week on controller medication. More information about this criterion can be found in the protocol. Diagnosis of asthma made over 1 year prior to study entry Exclusion Criteria: Have severe, persistent asthma (according to National Asthma Education and Prevention Program [NAEPP] classification) as evidenced by those who require a dose of greater than 500 mcg of fluticasone/day or equivalent of another inhaled corticosteroid OR who have been hospitalized for asthma within 6 months prior to study entry Life-threatening asthma exacerbation requiring intubation or mechanical ventilation or resulting in a hypoxic seizure in the 2 years prior to study entry History of anaphylaxis of Grade 2 or higher as defined in the protocol Unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunologic diseases that, in the opinion of the investigator, may interfere with the study or pose additional risk to the patient. More information about this criterion can be found in the protocol. Taking medications that could induce gastrointestinal reactions during the study. Participants taking such medications must prove to be stable with no side effects for at least 3 months prior to study screening to be considered eligible. Received an investigational drug in the 30 days prior to study entry OR plan to receive an investigational drug during the study Received allergen immunotherapy in the 180 days prior to screening or plan to initiate or resume allergen immunotherapy during the study Taking tricyclic antidepressants or beta-adrenergic blocker drugs Received omalizumab in the 3 months prior to study screening Known contraindication to therapy with cockroach extract used in this study Mental illness that would interfere with the participant's ability to comply to study requirements History of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the study Plan to leave study area during the study Does not primarily speak English, including caretakers of participants when the participant is a child Cannot perform spirometry Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wood, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine, 600 North Wolfe St, CMSC 1102
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16675328
Citation
Cox LS, Larenas Linnemann D, Nolte H, Weldon D, Finegold I, Nelson HS. Sublingual immunotherapy: a comprehensive review. J Allergy Clin Immunol. 2006 May;117(5):1021-35. doi: 10.1016/j.jaci.2006.02.040.
Results Reference
background
PubMed Identifier
15898976
Citation
Gidaro GB, Marcucci F, Sensi L, Incorvaia C, Frati F, Ciprandi G. The safety of sublingual-swallow immunotherapy: an analysis of published studies. Clin Exp Allergy. 2005 May;35(5):565-71. doi: 10.1111/j.1365-2222.2005.02240.x.
Results Reference
background
PubMed Identifier
16675331
Citation
Nelson HS. Advances in upper airway diseases and allergen immunotherapy. J Allergy Clin Immunol. 2006 May;117(5):1047-53. doi: 10.1016/j.jaci.2005.12.1306. Epub 2006 Mar 6.
Results Reference
background
PubMed Identifier
15575924
Citation
Wilson DR, Lima MT, Durham SR. Sublingual immunotherapy for allergic rhinitis: systematic review and meta-analysis. Allergy. 2005 Jan;60(1):4-12. doi: 10.1111/j.1398-9995.2005.00699.x.
Results Reference
background
PubMed Identifier
24184147
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.
Results Reference
result
Links:
URL
http://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID)

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Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma

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