Thyroid Hormones Treatment in Asthma Exacerbation (THINAS)

Rambam Health Care Campus

Status: Unknown

Conditions: Asthma

Treatments: Drug: IV thyroxin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02086799

354-13CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

IV thyroxin

Experimental group

Description:

IV thyroxin

Treatment:

Drug: IV thyroxin

control IV saline

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo