The study will investigate the efficacy and safety of subcutaneous interferon alpha -2a to eradicate rhinovirus in patients with primary hypogammaglobulinemia. Patients with hypogammaglobulinemia have persistent rhinovirus infections. Rhinovirus may worsen pulmonary complications. Pegylated interferon alpha with ribavirin appear to effectively clear persistent rhinovirus infections in hypogammaglobulinemia patients. Patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection will be randomly assigned in a double-blind fashion to receive either * Group 1: subcutaneous pIFNα2a * Group 2: subcutaneous placebo Subjects will have scheduled study visits at 1-week and at 2-month after entry to study. In addition, possible bacterial infections will be treated with antibiotics. Each patient will be followed with weekly nasal surveillance samples for 2 months and a symptom diary. Blood draws take place at study entry, 1-week and 2-month time-points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
0,9% natrium chlorine solution
Turku university hospital
Turku, Finland
Duration of respiratory symptoms
Time frame: within 2 months
eradication of rhinovirus from nasal secretion (nasal secretion sample analyzed by rhinovirus PCR)
Time frame: within 2 months (sample taken daily for 7 days, then weekly for 7 weeks)
time to next respiratory infection
Time frame: within 2 months
duration of respiratory symptoms
daily questionnaire for 8 weeks
Time frame: 2 months
rhinovirus genotype-specific persistence
Time frame: 2 months
adverse events
symptom diary
Time frame: 2 months
blood counts
at time points 0, 1 wk and 2 months
Time frame: 2 months
alanine aminotransferase
at time points 0, 1 wk and 2 months
Time frame: 2 months
creatinine
at time points 0, 1 wk and 2 months
Time frame: 2 months
severity of respiratory functions
daily questionnaire for 8 weeks
Time frame: 2 months
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