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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
112
Minsk Regional Clinical Hospital
Minsk, Belarus
City Clinical Hopsital #10
Minsk, Belarus
Kazan State Medical Academy
Kazan', Russia
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
D. Farinae Specific IgG4 Change From Baseline to End of Treatment
primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment
Time frame: 60 days from baseline
D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment
secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment
Time frame: 60 days from baseline
D. Farinae Specific IgE Change From Baseline to End of Treatment
the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo
Time frame: 60 days from baseline
D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment
the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo
Time frame: 60 days from baseline
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