This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes. The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation. The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.
Study population: The study will include adults admitted to Internal Medicine B (IMB) department, Internal Medicine H (IMH) department or medical intensive care unit (MICU) in Rambam-Health Care Campus for moderate to severe Asthma exacerbation. The severity of the exacerbation will be based on several acceptable clinical and laboratory criteria, including breathless, alertness, pulse rate, respiratory rate, partial pressure of oxygen in arterial blood (PaO2), partial pressure of carbon dioxide in arterial blood (PaCO2), oxygen saturation, peak expiratory flow (PEF). Study protocol: The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the PEF rate to normal values or personal base line. PEF rates will be examined first after initial bronchodilator therapy and then, every 8 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Patients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours.
Patients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours
Rambam health care campus
Haifa, Israel
time to normalization of PEF (peak expiratory flow)
The primary endpoint is the time to return of the PEF rate to normal values or personal base line.
Time frame: one week
Length of stay
• Length of stay (in cases of hospitalization in the internal medicine departments) or length of intubation (in cases of hospitalization in the MICU).
Time frame: one week
Time to oxygenation
Time to oxygen saturation \> 95% (while breathing spontaneously and without oxygen supplements)
Time frame: one week
heart rate
Time to normalization of heart rate
Time frame: one week
respiratory rate
Time to normalization of respiratory rate
Time frame: one week
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