Chronic Cough (CC)Early Phase 1NCT06634823
Efficacy of Intramuscular Steroid Injection for Chronic Cough.
A Early Phase 1 study testing Triamcinolone Acetonide Injectable Suspension and Saline injection in people with Chronic Cough (CC) and Laryngeal Disease, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cough (CC), Laryngeal Disease, Coughing
- What is being tested?
- Triamcinolone Acetonide Injectable Suspension and Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 30 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History consistent with chronic unexplained or refractory cough
- Age ≥ 18
Who cannot join
- 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
Show all 9Show fewer
- Uncontrolled reflux
- Prior superior laryngeal nerve injection
- Current neuromodulating medication use for chronic cough*
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29403
Laryngology Office, 843-792-6755, howser@musc.edu
Lauren Howser, MD
About this study
Official title: Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained 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.
Read the 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.
- Conditions
- Chronic Cough (CC), Laryngeal Disease, Coughing
- Being tested
- Triamcinolone Acetonide Injectable Suspension, Saline injection
- Keywords
- Throat, Chronic cough, Neurogenic cough, Unexplained cough
- Medical subject headings
- Chronic Cough, Laryngeal Diseases, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide Injectable SuspensionDrug
Triamcinolone injection into deltoid muscle (arm)
Saline injectionDrug
Saline injection into deltoid muscle (arm)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo injection into deltoid (arm) Receives: Drug: Saline injection |
| Steroid | Experimental | Triamcinolone injection into deltoid (arm) Receives: Drug: Triamcinolone Acetonide Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
Visual Analog Scale
Visual analog scale for symptom severity. This will be reported as a percentage (ratio of X marked spot to total line).
Measured: 4 weeks
Dichotomous yes/no to symptom improvement
Yes/No response to cough improvement
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start2 Dec 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cough (CC)Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Howser, Medical University of South Carolina
- Investigators
- Lauren Howser, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634823
- Sponsor's protocol ID
- Pro00140403
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be made available at the end of the trial with de-identified patient data. A data dictionary will be provided so that the data can be fully interpreted.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough
- ClinicalTrials.gov ID
- NCT06634823
- Acronym / sponsor ID
- Pro00140403
- Conditions
- Chronic Cough (CC), Laryngeal Disease, Coughing
- Keywords
- Throat, Chronic cough, Neurogenic cough, Unexplained cough
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Saline injectionPlacebo injection into deltoid (arm) |
| Steroid | Experimental | Drug: Triamcinolone Acetonide Injectable SuspensionTriamcinolone injection into deltoid (arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History consistent with chronic unexplained or refractory cough
- Age ≥ 18
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone Acetonide Injectable SuspensionTriamcinolone injection into deltoid muscle (arm) | Drug | Steroid |
| Saline injectionSaline injection into deltoid muscle (arm) | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Visual Analog Scale
Time frame: 4 weeks
Dichotomous yes/no to symptom improvement
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. IPD can be made available at the end of the trial with de-identified patient data. A data dictionary will be provided so that the data can be fully interpreted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Howser principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Triamcinolone Acetonide Injectable Suspension and Saline injection in people with Chronic Cough (CC) and Laryngeal Disease, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Meenan (843-792-6755, meenan@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leicester Cough Questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.