RECRUITING

Efficacy of Intramuscular Steroid Injection for Chronic Cough.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary goal of this study is to test the hypothesis that injecting steroid intramuscularly is an effective treatment for unexplained chronic cough. This will be achieved through the design of a prospective, placebo-controlled, single-blind, randomized clinical trial in which one group of patients will undergo a steroid injection into the deltoid muscle and the second group will undergo a placebo injection into the deltoid muscle. Data to determine if a clinically significant difference exists between the outcomes of the two groups will be measured by a dichotomous yes/no response to improvement, the Leicester Cough Questionnaire, and a visual analogue scale for symptom severity. This will provide the answer to the general question of whether or not the intramuscular injections are clinically effective for patients with unexplained chronic cough. Furthermore, any adverse reactions will be thoroughly documented. If this hypothesized treatment is proven effective, this can greatly improve the care of chronic cough patients by allowing for an evidence-based treatment option and a treatment option that may improve access to care. While the superior laryngeal nerve (SLN) injection is typically performed by fellowship trained laryngologists, intramuscular injections could be more widely utilized by general otolaryngologists or providers in other fields of medicine.

Official Title

Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough

Quick Facts

Study Start:2024-12-02
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06634823

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History consistent with chronic unexplained or refractory cough
  2. * Age ≥ 18
  1. * Current smokers
  2. * Uncontrolled diabetes (A1c\>7%)
  3. * Patients on ACE inhibitors or Angiotensin II receptor blockers (ARBs)
  4. * Abnormal pulmonary function testing (PFTs) since start of the cough
  5. * Patients with uncontrolled obstructive sleep apnea
  6. * Abnormal chest X-ray within past 6 months
  7. * Uncontrolled reflux
  8. * Prior superior laryngeal nerve injection
  9. * Current neuromodulating medication use for chronic cough\*

Contacts and Locations

Study Contact

Kirsten Meenan
CONTACT
843-792-6755
meenan@musc.edu
Lauren Howser
CONTACT
843-792-6755
howser@musc.edu

Principal Investigator

Lauren Howser
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29403
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Lauren Howser, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-02
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-12-02
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Throat
  • Chronic cough
  • Neurogenic cough
  • Unexplained cough

Additional Relevant MeSH Terms

  • Chronic Cough (CC)
  • Laryngeal Disease
  • Coughing