Clinical trial NCT06634823: Efficacy of Intramuscular Steroid Injection for Chronic Cough.
Official title: Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Cough (CC)
Laryngeal Disease
Coughing
Keywords: Throat
Chronic cough
Neurogenic cough
Unexplained cough
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 the central and peripheral nervous system may be an important target for steroid hormones and their metabolites, which may have impact on inflammation and excitatory action.

Superior laryngeal nerve injections have been well studied in literature and were recently studied here at the Medical University of South Carolina in a prospective placebo-controlled trial for use in neurogenic cough. This study showed that there was a significant improvement in cough compared to placebo. This study was completed using randomization of 17 patients into the control and steroid/lidocaine injection groups. In the treatment group, 80% of patients reported improvement in symptoms, while in the control group only 14% of patients reported improvement. The Leicester Cough Questionnaire (LCQ) and visual analog scoring were used to compare cough data from pre and post injection.

The hypothesis revolves around the idea that SLN blocks may actually work systemically, so the site of injection may not be the key in cough improvement. This combined with the theory on glial cell involvement and systemic steroid use to inhibit the neuroinflammatory pathway leads us to believe that intramuscular steroid injections could improve chronic cough. Therefore, this study focuses on the use of systemic intramuscular steroids in patients with chronic cough and we hypothesize that patients will have improvement in cough severity. By opening another treatment option that could be utilized by general (non-fellowship trained) otolaryngologists, access to care and treatment may be improved for patients with chronic cough.

Eligibility criteria: 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\*

Primary outcomes:
measure: Leicester Cough Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 4 weeks
measure: Dichotomous yes/no to symptom improvement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Lauren Howser
role: PRINCIPAL_INVESTIGATOR
References: