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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00829985
Other study ID # DAIT ICAC-12
Secondary ID BioCSI
Status Completed
Phase Phase 1/Phase 2
First received January 26, 2009
Last updated June 2, 2015
Start date January 2009
Est. completion date December 2009

Study information

Verified date June 2015
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

- 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

- Pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Glycerinated German Cockroach Allergenic Extract
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.
Placebo
Daily doses of cockroach allergenic extract placebo placed under the tongue to dissolve

Locations

Country Name City State
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States Boston University School of Medicine Boston Massachusetts
United States Childrens Memorial Hospital Chicago Illinois
United States National Jewish Center Denver Colorado

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Inner-City Asthma Consortium

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. Review. — View 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 Con — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. Baseline through 6-months of treatment No
Secondary 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. Baseline through 6-months of treatment No
Secondary 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. Baseline through 6-months of treatment No
Secondary Percent of Participants With the Occurrence of Adverse Events (AE) Percent of participants who experienced at least one adverse event Participant enrollment to end of study (up to 6 months post-baseline) Yes
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