Thyroid Hormones Treatment in Asthma Exacerbation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is There a Role for Thyroid Hormones Treatment in the Set-up of Acute Moderate to Severe Asthma Exacerbation

Conditions
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Asthma

Intervention / Treatment
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* Drug: IV thyroxin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV thyroxin<br>IV thyroxin | Drug: IV thyroxin<br>* Patients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours.<br>* Other names: euthrux;|
| Placebo Comparator: control IV saline<br>Placebo | Drug: Placebo<br>* Patients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | one week | 
| Time to oxygenation | Time to oxygen saturation > 95% (while breathing spontaneously and without oxygen supplements) | one week | 
| heart rate | Time to normalization of heart rate | one week | 
| respiratory rate | Time to normalization of respiratory rate | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, thyroid hormones, treatment, asthma exacerbation