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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT002326-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This study will investigate sublingual immunotherapy (SLIT), a treatment involving antigens placement under the tongue to help asthma sufferers build a tolerance to the allergy-causing substances. Specifically, this study will determine the effectiveness of SLIT at two different dosing regimens for patients with intermittent mild asthma caused by dust mites.
Asthma is a serious lung condition that is the leading cause of long-term illness in children. Many common household substances can trigger or worsen an asthma attack. It is important for people to reduce household allergens and learn effective treatments for specific types of asthma. Inhaled short-acting beta agonist such as albuterol is the standard treatment for mild, intermittent asthma. However, recent studies have shown that adding allergen-specific immunotherapy to your current asthma therapy can help to control asthma symptoms. This study will determine the safety and effectiveness of SLIT in two different dosing regimens in treating patients with house dust mite-induced allergic rhinitis/mild intermittent asthma.
Participants will be randomly assigned to receive low dose SLIT, high dose SLIT, or placebo for at least 12 months. House dsut mite-induced allergy skin tests will be performed at study entry, at selected timepoints throughout the study, and at the end of the study. The tests will determine whether SLIT creates an immune tolerance state as well as whether SLIT acts via local or systemic immunological systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose SLIT | Active Comparator | Low dose SLIT |
|
| High dose SLIT | Active Comparator | High dose SLIT |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| House Dust Mite SLIT | Biological | low dose SLIT 143 Allergen Units(AU)/ml daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | Antigen challenge was performed using the antigen house dust mite. Increasing doses of antigen were inhaled and then lung function (using the procedure Spirometry, measuring Forced Expiatory Volume in the 1st second FEV1) was measured after each dose. The challenge was stopped once the lung function (FEV1) was dropped by 20% of percent predicted. The dose of antigen that caused a 20% drop in lung function is considered the bronchial threshold. The higher the dose of antigen that causes the drop in lung function, the higher tolerance a participant has of inhaling house dust mite. This dose was measure at baseline and then again after 12-18 months of treatment with sublingual house dust mite antigen.Cumulative breath units is the unit of measure to indicate how much antigen is tolerated before the FEV1 is dropped by 20%. Cumulative breath units is also known as breath units. | baseline and after 12-18 months treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert K. Bush, MD | University of Wisconsin Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Medical School | Madison | Wisconsin | 53706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21333346 | Result | Bush RK, Swenson C, Fahlberg B, Evans MD, Esch R, Morris M, Busse WW. House dust mite sublingual immunotherapy: results of a US trial. J Allergy Clin Immunol. 2011 Apr;127(4):974-81.e1-7. doi: 10.1016/j.jaci.2010.11.045. Epub 2011 Feb 18. |
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Out of 31 participants enrolled, 6 participants withdrew due to non-treatment-ascribed-event, 4 participants withdrew due to treatment-ascribed-events.
Only 21 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | Low dose SLIT Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily |
| FG001 | High Dose | High dose SLIT High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily |
| FG002 | Placebo | Placebo Placebo SLIT: Placebo SLIT daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | Low dose SLIT Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily |
| BG001 | High Dose | High dose SLIT High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | Antigen challenge was performed using the antigen house dust mite. Increasing doses of antigen were inhaled and then lung function (using the procedure Spirometry, measuring Forced Expiatory Volume in the 1st second FEV1) was measured after each dose. The challenge was stopped once the lung function (FEV1) was dropped by 20% of percent predicted. The dose of antigen that caused a 20% drop in lung function is considered the bronchial threshold. The higher the dose of antigen that causes the drop in lung function, the higher tolerance a participant has of inhaling house dust mite. This dose was measure at baseline and then again after 12-18 months of treatment with sublingual house dust mite antigen.Cumulative breath units is the unit of measure to indicate how much antigen is tolerated before the FEV1 is dropped by 20%. Cumulative breath units is also known as breath units. | Posted | Mean | Standard Deviation | cumulative breath units | baseline and after 12-18 months treatment |
|
Up to 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | Low dose SLIT Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| oral lesion | General disorders | Systematic Assessment | Oral lesion or canker sore |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Crisafi | UW Madison | 608-262-5240 | gmc@medicine.wisc.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D053120 | Respiratory Aspiration |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| High dose SLIT |
| Biological |
House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily |
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| Placebo SLIT | Biological | Placebo SLIT daily |
|
| Pregnancy |
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| Poor adherence |
|
| optic neuritis |
|
| Adverse Event |
|
| BG002 | Placebo | Placebo Placebo SLIT: Placebo SLIT daily |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Low Dose |
Low dose SLIT Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily |
| OG001 | High Dose | High dose SLIT High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily |
| OG002 | Placebo | Placebo Placebo SLIT: Placebo SLIT daily |
|
|
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | High Dose | High dose SLIT High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily | 0 | 10 | 0 | 10 | 10 | 10 |
| EG002 | Placebo | Placebo Placebo SLIT: Placebo SLIT daily | 0 | 11 | 0 | 11 | 11 | 11 |
| throat irritation | General disorders | Systematic Assessment | Sore throat or strep throat |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | URI and/or asthma symptoms, pueumonia |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal issues | Gastrointestinal disorders | Systematic Assessment | Constipation, black stool, nausea |
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| Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Head cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment | hand wrist, ankle or back sprain |
|
| Reproductive issues | Reproductive system and breast disorders | Systematic Assessment | Clogged milk duct, irregular menses, mood swings with menstruation, |
|
| Eye infection | Eye disorders | Systematic Assessment | Eye infection or pink eye |
|
| Dermatologic issues | Skin and subcutaneous tissue disorders | Systematic Assessment | Mole removed with stitches, skin breakout, cyst on head |
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| Ear infection | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Optic neuritis | General disorders | Systematic Assessment |
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| Pain due to wisdom teeth extraction | General disorders | Systematic Assessment |
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| Muffled hearing | General disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |