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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV thyroxin | Experimental | IV thyroxin |
|
| control IV saline | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV thyroxin | Drug | Patients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| gidon berger, MD | Contact | 972 502061166 | g_berger@rambam.health.gov.il | |
| nizar andria, MD | Contact | 972 502062851 | nizar.andria@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zaher S Azzam, prof. | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | 31096 | Israel |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Placebo | Drug | Patients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours |
|
|
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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |