Asthma
Conditions
Keywords
asthma, thyroid hormones, treatment, asthma exacerbation
Brief summary
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.
Detailed description
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.
Interventions
DRUGIV thyroxin
Patients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours.
DRUGPlacebo
Patients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Known Asthma * The exacerbation is defined as moderate or severe. * Not currently enrolled as an active participant in another clinical trial of a medical therapy or device. * The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy
Exclusion criteria
* 60 years of age or older * Known thyroid disorders * Subject where thyrotoxicosis is suspected * Known heart disease * Heart rate \> 140
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to normalization of PEF (peak expiratory flow) | one week | The primary endpoint is the time to return of the PEF rate to normal values or personal base line. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| respiratory rate | one week | Time to normalization of respiratory rate |
| Length of stay | one week | • Length of stay (in cases of hospitalization in the internal medicine departments) or length of intubation (in cases of hospitalization in the MICU). |
| Time to oxygenation | one week | Time to oxygen saturation \> 95% (while breathing spontaneously and without oxygen supplements) |
| heart rate | one week | Time to normalization of heart rate |
Countries
Israel
Contacts
Primary Contactgidon berger, MD
Backup Contactnizar andria, MD
Outcome results
None listed