NCT00200850

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

May 1, 2019

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Results QC Date

April 15, 2019

Last Update Submit

May 21, 2019

Conditions

Asthma

Keywords

BreathingAllergyMites, House Dust

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Low dose SLIT

ACTIVE COMPARATOR

Low dose SLIT

Biological: House Dust Mite SLIT

High dose SLIT

ACTIVE COMPARATOR

High dose SLIT

Biological: High dose SLIT

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo SLIT

Interventions

House Dust Mite SLITBIOLOGICAL

low dose SLIT 143 Allergen Units(AU)/ml daily

Low dose SLIT
High dose SLITBIOLOGICAL

House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily

High dose SLIT
Placebo SLITBIOLOGICAL

Placebo SLIT daily

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • House dust mite-induced allergic rhinitis/mild intermittent asthma

You may not qualify if:

  • Use of previous allergy immunotherapy for house dust mite asthma
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Medical School

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

  • 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.

    PMID: 21333346RESULT

MeSH Terms

Conditions

AsthmaRespiratory AspirationHypersensitivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gina Crisafi
Organization
UW Madison
gmc@medicine.wisc.edu
608-262-5240

Study Officials

  • Robert K. Bush, MD

    University of Wisconsin Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

June 12, 2019

Results First Posted

June 12, 2019

Record last verified: 2019-05

Locations

US(1)