Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects

• ClinicalTrials.gov Identifier: NCT00389363
• Recruitment Status: Completed
• First Posted: October 18, 2006
• Last Update Posted: August 17, 2010
• Sponsor: ALK-Abelló A/S
• Information provided by: ALK-Abelló A/S

Tracking Information

• First Submitted Date: October 17, 2006
• First Posted Date: October 18, 2006
• Last Update Posted Date: August 17, 2010
• Study Start Date: August 2006
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 17, 2006): Use of inhaled corticosteroid (ICS).
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 17, 2006)

• Use of rescue medication and symptoms.
• Quality of Life.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects
• Official Title: A Phase II-III Trial Assessing the Efficacy and Safety of Three Doses of the ALK HDM Tablet in House Dust Mite Allergic Patients
• Brief Summary: The purpose of the trial is to determine if treatment of asthma patients allergic to house dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Asthma
• Intervention: Drug: ALK HDM tablet
• Study Arms: Not Provided

Publications *

• Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
• Mosbech H, Canonica GW, Backer V, de Blay F, Klimek L, Broge L, Ljørring C. SQ house dust mite sublingually administered immunotherapy tablet (ALK) improves allergic rhinitis in patients with house dust mite allergic asthma and rhinitis symptoms. Ann Allergy Asthma Immunol. 2015 Feb;114(2):134-40. doi: 10.1016/j.anai.2014.11.015.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 17, 2006): 800
• Original Enrollment: Same as current
• Actual Study Completion Date: April 2008
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• A history of house dust mite induced asthma
• Use of inhaled corticosteroids (ICS)
• Positive skin prick test to house dust mites
• Positive specific IgE to house dust mites

Exclusion Criteria:

• FEV1 lower than 70%

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00389363
• Other Study ID Numbers: MT-02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: ALK-Abelló A/S
• Collaborators: Not Provided

Investigators

• Study Director: Kim Simonsen, MD.; ALK-Abelló

• PRS Account: ALK-Abelló A/S
• Verification Date: August 2010