Efficacy of Intramuscular Steroid Injection for Chronic Cough.

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Triamcinolone Acetonide Injectable Suspension

    Drug

    Triamcinolone injection into deltoid muscle (arm)

  • Saline injection

    Drug

    Saline injection into deltoid muscle (arm)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: SteroidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 weeks

Secondary outcomes

1

Visual Analog Scale

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

Time frame
4 weeks
2

Dichotomous yes/no to symptom improvement

Yes/No response to cough improvement

Time frame
4 weeks

Other outcomes

Sponsors and contacts

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