Asthma Clinical Trial
Official title:
A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-12)
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Inner-City Asthma Consortium |
United States,
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
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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