Thyroid Hormones Treatment in Asthma Exacerbation

NCT02086799 | Unknown

• 1 other identifier: 354-13CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; thyroid hormones; treatment; asthma exacerbation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Length of stay

  one week

• Time to oxygenation

  one week

• heart rate

  one week

• respiratory rate

  one week

Study Arms (2)

IV thyroxin

EXPERIMENTAL

IV thyroxin

Drug: IV thyroxin

control IV saline

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

IV thyroxin DRUG

Patients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours.

Also known as: elthyroxin, thyroxin, euthrux

IV thyroxin

Placebo DRUG

Patients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours

Also known as: saline

control IV saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• years of age or older
• Known thyroid disorders
• Subject where thyrotoxicosis is suspected
• Known heart disease
• Heart rate \> 140

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Asthma

Interventions

Thyroxine; Sodium Chloride

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zaher S Azzam, prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gidon berger, MD

CONTACT

972 502061166; g_berger@rambam.health.gov.il

nizar andria, MD

CONTACT

972 502062851; nizar.andria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: March 13, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

IL (1)