Rhinovirus Infection
Conditions
Brief summary
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.
Interventions
DRUGpegylated interferon alfa 2
OTHERPlacebo
0,9% natrium chlorine solution
Sponsors
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years), * primary hypogammaglobulinemia with regular immunoglobulin replacement therapy, * rhinovirus positive from nasal swab, * thrombocytes over 90 x109/L, * Neutrophiles \> 1,5 x109/L * written informed consent.
Exclusion criteria
* Participation to another study, * need for intensive care unit treatment, * difficulties to understand national language, pregnancy and breastfeeding, * any somatic, psychiatric or social disease or issue which in the opinion of the investigator makes participation in the trial not being in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of respiratory symptoms | within 2 months |
| eradication of rhinovirus from nasal secretion (nasal secretion sample analyzed by rhinovirus PCR) | within 2 months (sample taken daily for 7 days, then weekly for 7 weeks) |
| time to next respiratory infection | within 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood counts | 2 months | at time points 0, 1 wk and 2 months |
| alanine aminotransferase | 2 months | at time points 0, 1 wk and 2 months |
| duration of respiratory symptoms | 2 months | daily questionnaire for 8 weeks |
| severity of respiratory functions | 2 months | daily questionnaire for 8 weeks |
| creatinine | 2 months | at time points 0, 1 wk and 2 months |
| rhinovirus genotype-specific persistence | 2 months | — |
| adverse events | 2 months | symptom diary |
Countries
Finland
Contacts
Primary ContactTuomas Jartti, MD
Backup ContactAuli Lammela, MD
Outcome results
None listed