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Thyroid Hormones Treatment in Asthma Exacerbation

Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: IV thyroxin (Drug); Placebo (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Rambam Health Care Campus

Official(s) and/or principal investigator(s):
Zaher S Azzam, prof., Principal Investigator, Affiliation: Rambam Health Care Campus

Overall contact:
gidon berger, MD, Phone: 972 502061166, Email: g_berger@rambam.health.gov.il

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.

Clinical Details

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

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

Primary outcome: time to normalization of PEF (peak expiratory flow)

Secondary outcome:

Length of stay

Time to oxygenation

heart rate

respiratory rate

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

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

gidon berger, MD, Phone: 972 502061166, Email: g_berger@rambam.health.gov.il

Rambam health care campus, Haifa 31096, Israel; Not yet recruiting
gidon berger, MD, Phone: 972 502061166, Email: g_berger@rambam.health.gov.il
Additional Information

Starting date: July 2014
Last updated: July 29, 2014

Page last updated: August 23, 2015

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