Thyroid Hormones Treatment in Asthma Exacerbation

Not Applicable

• Conditions: Asthma
• Interventions: Drug: IV thyroxin; Drug: Placebo

• Registration Number: NCT02086799
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Status Verified: 2014-07
• Study Start: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV thyroxin	IV thyroxin	IV thyroxin
control IV saline	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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).
respiratory rate	one week	Time to normalization of respiratory rate

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel