Thyroid Hormones Treatment in Asthma Exacerbation

Asthma Clinical Trial

— THINAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02086799
• Other study ID #: 354-13CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 11, 2014
• Last updated: July 29, 2014
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2014
• Source: Rambam Health Care Campus
• Contact: gidon berger, MD
• Phone: 972 502061166
• Email: g_berger[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• IV thyroxin
Patients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours.
• Placebo
Patients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Time to oxygenation	Time to oxygen saturation > 95% (while breathing spontaneously and without oxygen supplements)	one week	No
Secondary	heart rate	Time to normalization of heart rate	one week	Yes
Secondary	respiratory rate	Time to normalization of respiratory rate	one week	No