Clinical trial NCT00829985: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rhinitis, Allergic, Perennial
Asthma
Keywords: Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Immunotherapy
Asthma
Nasal Allergies
Hypersensitivity
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Inner-City Asthma Consortium
First posted: 2009-01-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difference in German Cockroach-Specific Serum IgE Over Time
timeFrame: Baseline through 6-months of treatment
Secondary outcomes:
measure: Difference in German Cockroach-Specific Serum IgG4 Over Time
timeFrame: Baseline through 6-months of treatment
measure: Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)
timeFrame: Baseline through 6-months of treatment
measure: Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)
timeFrame: Baseline through 6-months of treatment
measure: Percent of Participants With the Occurrence of Adverse Events (AE)
timeFrame: Participant enrollment to end of study (up to 6 months post-baseline)
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Center
state: Colorado
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Johns Hopkins University
name: Robert Wood, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.