Who is sponsoring NCT03250975?

NCT03250975 is sponsored by Vanderbilt University Medical Center.

What drugs are being tested in NCT03250975?

Interventions in NCT03250975: Budesonide and Azithromycin, Placebo control of budesonide and azithromycin.

What condition does NCT03250975 study?

NCT03250975 studies Intubation Complication.

Is NCT03250975 still recruiting?

NCT03250975 is currently active, enrolled. Last updated 3 November 2025.

Last reviewed 2025-11-03 · How we verify

NCT03250975

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Incidence of Acute Laryngeal Injury Following Endotracheal Intubation

Active, enrolled Phase 1, PHASE2 Last updated 3 November 2025

What this trial tests

Phase 1, PHASE2 trial testing Budesonide and Azithromycin in Intubation Complication in 64 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 August 2017

Primary endpoint
30 December 2026

30 December 2026

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	64
Start date	19 August 2017
Primary completion	30 December 2026
Estimated completion	30 December 2026
Sites	1 location across United States

Drugs / interventions tested

Budesonide and Azithromycin — full drug profile →
Placebo control of budesonide and azithromycin

Conditions studied

Intubation Complication — all drugs for Intubation Complication →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Intubation Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this investigation is to delineate the incidence of acute and chronic laryngeal injury following intubation within our health system. In addition, this study seeks to identify risk factors for airway injury that may provide information to help reduce the incidence of injury or increase the speed of diagnosis through hospital based process measures. Study Aims 1. Determine the incidence of acute laryngeal injury in patients with prolonged intubation. 2. Determine the incidence of chronic laryngeal injury in the subset of patients with acute laryngeal injury 3. Initiate a randomized control trial to investigate the ability of azithromycin and budesonide to improve objective and subjective breathing measures in patients with Acute Laryngeal injury (ALgI) following endotracheal intubation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Incidence and Outcomes of Acute Laryngeal Injury After Prolonged Mechanical Ventilation.
Shinn JR, Kimura KS, Campbell BR, Sun Lowery A, et al · · 2019 · cited 104× · PMID 31634236 · DOI 10.1097/ccm.0000000000004015
Early medical therapy for acute laryngeal injury (ALgI) following endotracheal intubation: a protocol for a prospective single-centre randomised controlled trial.
Lowery AS, Kimura K, Shinn J, Shannon C, et al · · 2019 · cited 5× · PMID 31352415 · DOI 10.1136/bmjopen-2018-027963

Verify or expand the search:

Other recruiting trials for Intubation Complication

Currently open trials in the same condition.

NCT07222007 — Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients · recruiting
NCT07125495 — The Effect of an Suction Toothbrush on the Development of Ventilator-Associated Pneumonia · NA · active not recruiting
NCT05960929 — InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS · Phase 3 · recruiting
NCT06533436 — Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord Fixation · NA · recruiting
NCT06750939 — The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Intubation · recruiting

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

NCT07005037 — Swallowing Impairments in ICU Survivors and Community-Dwelling Adults · not yet recruiting
NCT07527273 — Cognitive Enhancement in Recurrent Depression (The COG-D-R Study) · NA · not yet recruiting
NCT07295288 — Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis · Phase 4 · not yet recruiting
NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
NCT07224711 — The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery · Phase 4 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03250975 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 3 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03250975.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing