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Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)

Primary Purpose

Rhinitis, Allergic, Perennial, Asthma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Glycerinated German Cockroach Allergenic Extract

Placebo

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Immunotherapy, Asthma, Nasal Allergies, Hypersensitivity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of perennial allergic rhinitis, asthma, or both for a minimum of 1 year prior to study entry;
Positive skin prick test to German cockroach;
No known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo; and
Willing to sign the written Informed Consent prior to initiation of any study procedures.

Exclusion Criteria:

Cannot perform spirometry at screening;
Have clinically significant abnormal laboratory values;
Have an Asthma classification of severe persistent at screening;
Hospitalized for asthma within the 6 months prior to study entry;
Life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within the 2 years prior to study entry;
No access to a telephone;
Received allergen immunotherapy within the last 12 months prior to study entry and plan on initiating or resuming immunotherapy during the study;
Treatment with anti-immunoglobulin E (anti-IgE) therapy within 1 year of study entry;
Received an investigational drug within the 30 days prior to study entry and plan on using an investigational drug during the study;
Experienced nausea, vomiting, abdominal pain or cramps, or diarrhea within the 3 months prior to study entry;
Refuse to sign the Epinephrine Auto-injector Training Form;
Does not primarily speak English;
Plan to move from the area during the study period;
History of idiopathic anaphylaxis or anaphylaxis grade 3;
Using tricyclic antidepressants or beta-adrenergic blocker drugs;
Clinically unacceptable complete blood count (CBC) and liver function tests, as defined by a hemoglobin less than 11.5 in males and 10.0 in females, or platelet counts less than 150,000 and an Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) greater than twice the upper limit of normal;
Any condition that, in the opinion of the investigator, would interfere with the study; or
Pregnant or breastfeeding.

Sites / Locations

National Jewish Center
Childrens Memorial Hospital
Johns Hopkins University School of Medicine
Boston University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glycerinated German Cockroach Allergenic Extract

Placebo

Arm Description

Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.

Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.

Outcomes

Primary Outcome Measures

Difference in German Cockroach-Specific Serum IgE Over Time

Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.

Secondary Outcome Measures

Difference in German Cockroach-Specific Serum IgG4 Over Time

Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. This ratio is an indicator of immune modulation, however its clinical significance is unclear.

Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)

Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 30 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.

Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)

Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 60 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.

Percent of Participants With the Occurrence of Adverse Events (AE)

Percent of participants who experienced at least one adverse event

Full Information

NCT ID

NCT00829985

First Posted

January 26, 2009

Last Updated

February 14, 2017

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Inner-City Asthma Consortium

1. Study Identification

Unique Protocol Identification Number

NCT00829985

Brief Title

Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)

Official Title

A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-12)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 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

There is currently no effective way to prevent development of allergic rhinitis (nasal allergies) 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 efficacy of a sublingual cockroach extract given to adults with perennial allergic rhinitis, asthma, or both.

Detailed Description

Over the last two decades, the prevalence of asthma has dramatically increased in many parts of the world. Currently, there are no effective ways to prevent the development of nasal allergies and asthma, and there are no cures for these diseases. Sublingual immunotherapy (SLIT) may help reduce symptoms of allergy and asthma. The purpose of this study is to evaluate the safety and efficacy of a cockroach extract given sublingually to adults with perennial (year-round) nasal allergies, asthma, or both. At study entry, participants will receive a dose of placebo and then up to five incremental doses of cockroach extract or placebo at 15-minute intervals while observed by the clinical research staff. 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. For the next 6 months, participants will take the maximum study dose of cockroach extract or placebo daily at home. This study will consist of 8 study visits. Skin tests, breathing tests, and blood collection will occur at study screening and other visits during the study. 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 and oral exam, breathing test, and blood collection will occur at study entry and all follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Perennial, Asthma

Keywords

Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Immunotherapy, Asthma, Nasal Allergies, Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glycerinated German Cockroach Allergenic Extract

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Glycerinated German Cockroach Allergenic Extract

Intervention Description

Concentrated (1:20 w/v) daily doses of glycerinated German cockroach allergenic extract placed under the tongue to dissolve. The extract is also administered during the preliminary dosing visits in up to five escalating doses or until the maximum study dose (420 microliters, 1:20 w/v) is achieved.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Daily doses of cockroach allergenic extract placebo placed under the tongue to dissolve

Primary Outcome Measure Information:

Title

Difference in German Cockroach-Specific Serum IgE Over Time

Description

Time Frame

Baseline through 6-months of treatment

Secondary Outcome Measure Information:

Title

Difference in German Cockroach-Specific Serum IgG4 Over Time

Description

Time Frame

Baseline through 6-months of treatment

Title

Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)

Description

Time Frame

Baseline through 6-months of treatment

Title

Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)

Description

Time Frame

Baseline through 6-months of treatment

Title

Percent of Participants With the Occurrence of Adverse Events (AE)

Description

Percent of participants who experienced at least one adverse event

Time Frame

Participant enrollment to end of study (up to 6 months post-baseline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of perennial allergic rhinitis, asthma, or both for a minimum of 1 year prior to study entry; Positive skin prick test to German cockroach; No known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo; and Willing to sign the written Informed Consent prior to initiation of any study procedures. Exclusion Criteria: Cannot perform spirometry at screening; Have clinically significant abnormal laboratory values; Have an Asthma classification of severe persistent at screening; Hospitalized for asthma within the 6 months prior to study entry; Life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within the 2 years prior to study entry; No access to a telephone; Received allergen immunotherapy within the last 12 months prior to study entry and plan on initiating or resuming immunotherapy during the study; Treatment with anti-immunoglobulin E (anti-IgE) therapy within 1 year of study entry; Received an investigational drug within the 30 days prior to study entry and plan on using an investigational drug during the study; Experienced nausea, vomiting, abdominal pain or cramps, or diarrhea within the 3 months prior to study entry; Refuse to sign the Epinephrine Auto-injector Training Form; Does not primarily speak English; Plan to move from the area during the study period; History of idiopathic anaphylaxis or anaphylaxis grade 3; Using tricyclic antidepressants or beta-adrenergic blocker drugs; Clinically unacceptable complete blood count (CBC) and liver function tests, as defined by a hemoglobin less than 11.5 in males and 10.0 in females, or platelet counts less than 150,000 and an Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) greater than twice the upper limit of normal; Any condition that, in the opinion of the investigator, would interfere with the study; or Pregnant or breastfeeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Wood, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Study Chair

Facility Information:

Facility Name

National Jewish Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Childrens Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

Johns Hopkins University School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Boston University School of Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Citations:

PubMed Identifier

19100344

Citation

Ciprandi G, Contini P, Pistorio A, Murdaca G, Puppo F. Sublingual immunotherapy reduces soluble HLA-G and HLA-A,-B,-C serum levels in patients with allergic rhinitis. Int Immunopharmacol. 2009 Feb;9(2):253-7. doi: 10.1016/j.intimp.2008.11.009. Epub 2008 Dec 17.

Results Reference

background

PubMed Identifier

19106697

Citation

Passalacqua G, Pawankar R, Baena-Cagnani CE, Canonica GW. Sublingual immunotherapy: where do we stand? Present and future. Curr Opin Allergy Clin Immunol. 2009 Feb;9(1):1-3. doi: 10.1097/ACI.0b013e3283196a9b. No abstract available.

Results Reference

background

PubMed Identifier

19111571

Citation

Rolland JM, Gardner LM, O'Hehir RE. Allergen-related approaches to immunotherapy. Pharmacol Ther. 2009 Mar;121(3):273-84. doi: 10.1016/j.pharmthera.2008.11.007. Epub 2008 Dec 7.

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

https://www.niaid.nih.gov/

Description

National Institute of Allergy and Infectious Diseases (NIAID) website

URL

https://www.niaid.nih.gov/about/dait

Description

Division of Allergy, Immunology, and Transplantation (DAIT) website

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY223

Available IPD/Information Identifier

SDY223

Available IPD/Information Comments

ImmPort study identifier is SDY223.

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY223

Available IPD/Information Identifier

SDY223

Available IPD/Information Comments

ImmPort study identifier is SDY223.

Available IPD/Information Type

Study summary, -design, -adverse event(s), -interventions, -medications, -demographics, -study files.

Available IPD/Information URL

http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY223

Available IPD/Information Identifier

SDY223

Available IPD/Information Comments

ImmPort study identifier is SDY223.

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Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)

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