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NCT Number: NCT06634823

Efficacy of Intramuscular Steroid Injection for Chronic Cough.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location status: Recruiting

Location contact

Laryngology Office

CONTACT

[email protected]

843-792-6755

Lauren Howser, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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*

Treatment and study plan

Triamcinolone Acetonide Injectable Suspension

Drug

Triamcinolone injection into deltoid muscle (arm)

Saline injection

Drug

Saline injection into deltoid muscle (arm)

Primary outcomes

  1. Leicester Cough Questionnaire

    Time frame: 4 weeks

    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

  1. Visual Analog Scale

    Time frame: 4 weeks

    Visual analog scale for symptom severity. This will be reported as a percentage (ratio of X marked spot to total line).

  2. Dichotomous yes/no to symptom improvement

    Time frame: 4 weeks

    Yes/No response to cough improvement

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsten Meenan

CONTACT

[email protected]

843-792-6755

Lauren Howser

CONTACT

[email protected]

843-792-6755

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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