Asthma | Thyroid Hormones Treatment in Asthma Exacerbation
Asthma research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:IV thyroxinPatients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours.
Drug:PlaceboPatients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
IV thyroxinIV thyroxin
control IV salinePlacebo
Start Date: July 2014
Completed Date: December 2016
Primary Outcome: time to normalization of PEF (peak expiratory flow)
Secondary Outcome: Length of stay
Study sponsors, principal investigator, and references
Principal Investigator: Zaher S Azzam, prof.
Lead Sponsor: Rambam Health Care Campus