NCT02596321

A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma

A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis and/or Atopic Asthma Induced by House Dust Mites

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.

Detailed description

To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days, compared to placebo To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo

Conditions

• Allergy
• Asthma
• Rhinitis

Interventions

Type	Name	Description
DRUG	Mitizax	Allergen extract
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-11-04
• Last updated: 2018-03-01
• Results posted: 2017-12-18

Locations

9 sites across 2 countries: Belarus, Russia