Asthma
Conditions
Keywords
Breathing, Allergy, Mites, House Dust
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALHouse Dust Mite SLIT
low dose SLIT 143 Allergen Units(AU)/ml daily
BIOLOGICALHigh dose SLIT
House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily
BIOLOGICALPlacebo SLIT
Placebo SLIT daily
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* House dust mite-induced allergic rhinitis/mild intermittent asthma
Exclusion criteria
* Use of previous allergy immunotherapy for house dust mite asthma * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | baseline and after 12-18 months 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Low dose SLIT
Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily | 10 |
| High Dose High dose SLIT
High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily | 10 |
| Placebo Placebo
Placebo SLIT: Placebo SLIT daily | 11 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 |
| Overall Study | optic neuritis | 0 | 0 | 1 |
| Overall Study | Poor adherence | 0 | 0 | 1 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
| Overall Study | relocation | 1 | 0 | 1 |
| Overall Study | too busy | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Low Dose | High Dose | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 28.9 years STANDARD_DEVIATION 5.088 | 33.8 years STANDARD_DEVIATION 7.359 | 29.3 years STANDARD_DEVIATION 8.634 | 30.6 years STANDARD_DEVIATION 7.559 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 11 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 11 Participants | 29 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 8 Participants | 22 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 10 / 10 | 10 / 10 | 11 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 11 |
Outcome results
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.
Time frame: baseline and after 12-18 months treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose | Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | Baseline dose of antigen | 75.0 cumulative breath units | Standard Deviation 56.7 |
| Low Dose | Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | Post treatment dose of antigen | 74.8 cumulative breath units | Standard Deviation 57.3 |
| High Dose | Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | Baseline dose of antigen | 69.5 cumulative breath units | Standard Deviation 46.8 |
| High Dose | Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | Post treatment dose of antigen | 100.9 cumulative breath units | Standard Deviation 35.2 |
| Placebo | Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | Baseline dose of antigen | 141.4 cumulative breath units | Standard Deviation 147 |
| Placebo | Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment | Post treatment dose of antigen | 83.3 cumulative breath units | Standard Deviation 59.3 |