About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History consistent with chronic unexplained or refractory cough
Age ≥ 18
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Triamcinolone Acetonide Injectable Suspension
DrugTriamcinolone injection into deltoid muscle (arm)
Saline injection
DrugSaline injection into deltoid muscle (arm)
Treatment groups
Trial outcomes
Primary outcomes
Leicester Cough Questionnaire
The primary outcome for which this study is powered is the change in mean Leicester Cough Questionnaire (LCQ) scores, both global and specific domains (physical, psychological, and social) from baseline to 1-4 weeks post-treatment. This score will be 19-133, with higher score indicating better outcomes.
Secondary outcomes
Visual Analog Scale
Visual analog scale for symptom severity. This will be reported as a percentage (ratio of X marked spot to total line).
Dichotomous yes/no to symptom improvement
Yes/No response to cough improvement
Sponsors and contacts
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