Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough
Medical University of South Carolina
Summary
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.
Description
A significant subset of patients are found to have "unexplained chronic cough", which is a diagnosis of exclusion. For these patients, the etiology of the cough is often not isolated. However, the cause is thought to be related to hypersensitivity and inflammation of both the nerves involved in cough sensation and/or mucosa of the larynx. A similar theory described by Driessen et al. hypothesizes that neuroinflammation related to glial cells in central and peripheral neural pathways may contribute to chronic cough in a similar way to how chronic pain is mediated by this pathway. Glial cells in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * History consistent with chronic unexplained or refractory cough * Age ≥ 18 Exclusion Criteria: * Current smokers * Uncontrolled diabetes (A1c\>7%) * Patients on ACE inhibitors or Angiotensin II receptor blockers (ARBs) * Abnormal pulmonary function testing (PFTs) since start of the cough * Patients with uncontrolled obstructive sleep apnea * Abnormal chest X-ray within past 6 months * Uncontrolled reflux * Prior superior laryngeal nerve injection * Current neuromodulating medication use for chronic cough\*
Interventions
- DrugTriamcinolone Acetonide Injectable Suspension
Triamcinolone injection into deltoid muscle (arm)
- DrugSaline injection
Saline injection into deltoid muscle (arm)
Location
- Medical University of South CarolinaCharleston, South Carolina