Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634823
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Efficacy of Intramuscular Steroid Injection for Chronic Cough
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 yesno 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 andor 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 steroidlidocaine 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
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 steroidlidocaine 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None