AsthmaNCT00200850
Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy
A study testing House Dust Mite SLIT and High dose SLIT in people with Asthma, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- House Dust Mite SLIT and High dose SLIT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- House dust mite-induced allergic rhinitis/mild intermittent asthma
Who cannot join
- Use of previous allergy immunotherapy for house dust mite asthma
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Medical School
Madison, Wisconsin, 53706
About this study
Official title: Sublingual Immunotherapy in Dust Mite Allergy
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- House Dust Mite SLIT, High dose SLIT, Placebo SLIT
- Keywords
- Breathing, Allergy, Mites, House Dust
- Medical subject headings
- Asthma, Respiratory Aspiration, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
House Dust Mite SLITBiological
low dose SLIT 143 Allergen Units(AU)/ml daily
High dose SLITBiological
House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily
Placebo SLITBiological
Placebo SLIT daily
| Study group | Role | What they receive |
|---|---|---|
| Low dose SLIT | Active comparator | Low dose SLIT Receives: Biological: House Dust Mite SLIT |
| High dose SLIT | Active comparator | High dose SLIT Receives: Biological: High dose SLIT |
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo SLIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and after 12-18 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Robert K. Bush, MD, Principal investigator, University of Wisconsin Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200850
- Sponsor's protocol ID
- H-2005-0193
- Other IDs
- R21AT002326-01A1
- Status last verified
- May 2019
- First submitted
- 13 Sep 2005
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21333346
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Immunotherapy in Dust Mite Allergy
- ClinicalTrials.gov ID
- NCT00200850
- Acronym / sponsor ID
- H-2005-0193
- Conditions
- Asthma
- Keywords
- Breathing, Allergy, Mites, House Dust
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2006 (actual)
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 12 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose SLIT | Active comparator | Biological: House Dust Mite SLITLow dose SLIT |
| High dose SLIT | Active comparator | Biological: High dose SLITHigh dose SLIT |
| Placebo | Placebo comparator | Biological: Placebo SLITPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- House dust mite-induced allergic rhinitis/mild intermittent asthma
Key exclusion criteria (2 listed)
- Use of previous allergy immunotherapy for house dust mite asthma
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| House Dust Mite SLITlow dose SLIT 143 Allergen Units(AU)/ml daily | Biological | Low dose SLIT |
| High dose SLITHouse Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily | Biological | High dose SLIT |
| Placebo SLITPlacebo SLIT daily | Biological | Placebo |
Primary outcome
Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21333346Bush 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert K. Bush, MD principal investigator
University of Wisconsin Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing House Dust Mite SLIT and High dose SLIT in people with Asthma, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment (time frame: baseline and after 12-18 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00200850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.