Thyroid Hormones Treatment in Asthma Exacerbation (THINAS)

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

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 Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Drug: IV thyroxin; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: gidon berger, MD; Phone Number: 972 502061166; Email: g_berger@rambam.health.gov.il
• Study Contact Backup: Name: nizar andria, MD; Phone Number: 972 502062851; Email: nizar.andria@gmail.com

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
    • Contact: gidon berger, MD; Phone Number: 972 502061166; Email: g_berger@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Zaher S Azzam, prof., Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: treatment; asthma; asthma exacerbation; thyroid hormones
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 354-13CTIL