NCT00829985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 8, 2013

Completed
Last Updated

March 21, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

January 26, 2009

Results QC Date

January 31, 2013

Last Update Submit

February 14, 2017

Conditions

Rhinitis, Allergic, PerennialAsthma

Keywords

Rhinitis, Allergic, PerennialRhinitis, Allergic, SeasonalImmunotherapyAsthmaNasal AllergiesHypersensitivity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline through 6-months of treatment

Secondary Outcomes (4)

  • Difference in German Cockroach-Specific Serum IgG4 Over Time

    Baseline through 6-months of treatment

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

    Baseline through 6-months of treatment

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

    Baseline through 6-months of treatment

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

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

Study Arms (2)

Glycerinated German Cockroach Allergenic Extract

EXPERIMENTAL

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.

Biological: Glycerinated German Cockroach Allergenic Extract

Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

Glycerinated German Cockroach Allergenic ExtractBIOLOGICAL

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.

Glycerinated German Cockroach Allergenic Extract
PlaceboBIOLOGICAL

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

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Jewish Center

Denver, Colorado, 80206, United States

Location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (4)

  • 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.

    PMID: 19100344BACKGROUND

  • 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.

    PMID: 19106697BACKGROUND

  • 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.

    PMID: 19111571BACKGROUND

  • 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: 24184147RESULT

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialAsthmaRhinitis, Allergic, SeasonalHypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System DiseasesBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Results Point of Contact

Title
Director, Clinical Research 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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 21, 2017

Results First Posted

March 8, 2013

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

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.

Available IPD Datasets

Individual Participant Data Set (SDY223)Access
Study Protocol (SDY223)Access
Study summary, -design, -adverse event(s), -interventions, -medications, -demographics, -study files. (SDY223)Access

Locations

US(4)