Clinical trial NCT02086799: Thyroid Hormones Treatment in Asthma Exacerbation
Official title: Is There a Role for Thyroid Hormones Treatment in the Set-up of Acute Moderate to Severe Asthma Exacerbation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: asthma
thyroid hormones
treatment
asthma exacerbation
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: time to normalization of PEF (peak expiratory flow)
timeFrame: one week
Secondary outcomes:
measure: Length of stay
timeFrame: one week
measure: Time to oxygenation
timeFrame: one week
measure: heart rate
timeFrame: one week
measure: respiratory rate
timeFrame: one week
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Zaher S Azzam, prof.
role: PRINCIPAL_INVESTIGATOR
References: