CoughPhase 1CDTPilot2NCT05226299
Cough Desensitization Therapy: Pilot 2
A Phase 1 study testing Saline in people with Cough, run by University of Montana at 1 site in United States.
Trial summary
The purpose of this study is to investigate a modified behavioral treatment for chronic cough due to cough hypersensitivity syndrome (CHS). This type of CC is a non-productive cough that is due, in part, to over-expression of transient receptor potential vanilliod (TRPV) receptors in the airway epithelium, which… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cough
- What is being tested?
- Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 30 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Currently suffering from a cough that started at least 8 weeks ago
- Have seen at least one physician for the cough and have received medical treatment without success
- Normal chest x-ray, pulmonary function testing (completed by your physician or a qualified speech-language pathologist).
- Completion of a laryngoscopy (by ENT physician or qualified speech-language pathologist) with no evidence of an anatomical abnormality (i.e., masses or lesions such as nodules, cysts, or cancer) that could contribute to cough.
- Willing to take a pregnancy test before enrollment (if applicable)
Show all 9Show fewer
- Willing to use contraception during the study (if applicable; we will not be able to supply you with contraceptive methods)
- If you are diagnosed with asthma, you may enroll in the study if you are regularly followed by a pulmonologist who will verify, in writing, that your asthma symptoms are well-controlled (apart from cough symptoms) with your current medication protocol, which would not be altered when you are in the study. In order to remain in the study, your forced expiratory volume (FEV1), which will be measured during baseline lung function testing with spirometry, must be no less than 60% of predicted values given age, height, and weight. You must also carry a rescue inhaler with you when participating in all assessment and treatment sessions.
- Willing to sign an informed consent form
Who cannot join
- Under 18 years of age
- Positive for COVID-19 or presenting with any of the following symptoms of COVID- 19: fever or chills, sputum, difficulty breathing, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
- Have not followed current local, state, and CDC COVID-19 mitigation guidance, especially regarding travel.
- Unwilling to comply with COVID-19 precautions (see below)
- Currently a smoker of any substance
- Pregnant or attempting to become pregnant
Show all 19Show fewer
- Diagnosed with a respiratory or pulmonary condition (other than asthma) that commonly contributes to cough (e.g., chronic obstructive pulmonary disease, emphysema, lung cancer, bronchitis)
- Diagnosed with asthma that is not well managed and/or do not have the necessary written consent by a pulmonologist to be in the study.
- Suffering from any signs of upper respiratory illness
- Taken any of the following medications within the past month:
- lisinopril/Prinivil/Zestril
- captopril/Capoten
- enalapril/Epaned/Asotec, ramipril/Altace
- benazepril/Lotensin
- fosinopril/Monopril
- moexipril/Univasc
- perindopril/Aceon
- quinapril/Accupril
- trandolapril/Mavik
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cough Desensitization Therapy for Cough Hypersensitivity Syndrome: Pilot 2
The purpose of this study is to investigate a modified behavioral treatment for chronic cough due to cough hypersensitivity syndrome (CHS). This type of CC is a non-productive cough that is due, in part, to over-expression of transient receptor potential vanilliod (TRPV) receptors in the airway epithelium, which contribute to a dry cough elicited by typically non-tussive stimuli (e.g., cold air, smells) or by low doses of tussive stimuli (e.g., smoke). Currently available treatment options are limited to neuromodulator medications (e.g., gabapentin, amytriptiline) and behavioral cough suppression therapy (BCST), neither of which is 100% effective. The primary component of BCST is teaching patients to suppress their cough in the presence of an urge-to-cough. Studies have confirmed a reduction in cough sensitivity (as tested with inhaled capsaicin) following 1-4 weeks of successful cough suppression. However, patients with severe CHS are not able to suppress their cough in the presence of uncontrollable environmental stimuli and, hence, do not respond well to the therapy. The purpose of this study is to determine the potential of treating CHS by implementing BCST while stimulating cough with progressive concentrations of inhaled diluted aerosolized capsaicin. The investigators hypothesize this treatment will result in a reduction in cough-reflex sensitivity, cough-related quality of life, and cough frequency.
Read the detailed description
The study will be a randomized, placebo-controlled, blinded study. It will take place in three phases, across 10 weeks.
WEEK 1: BASELINE TESTING AND TRAINING (approximate time = 1 hour).
Cough sensitivity testing: Standardized procedures that have been established and approved by the FDA will be used to determine cough sensitivity. Participants will inhale capsaicin vapor (a known cough stimulant) through a nebulizer with dosimeter, that delivers a specific dose of capsaicin in a mist form. They will inhale doubling doses of capsaicin mist from .49 micromolar to 1000 micromolar. The testing will be stopped when the investigators find the dose that causes five coughs or after giving the 1000 micromolar dose, whichever comes first. This testing will take approximately 30 minutes.
Urge-to-cough (UTC) testing: Participants be asked to report their UTC on a scale from 0 (no UTC) to 10 (maximum UTC) after each mist of capsaicin and after being presented with the following stimulants/tasks that cause some people to cough: perfume, bleach, vinegar, wood chips, laundry soap, cleaning wipe, deep and fast breath through the mouth, sustained voicing, reading a 55 word passage, and yelling a short phrase). This testing will take about 10 minutes.
Cough-related quality of life: Participants will complete the Leicester Cough Questionnaire which is a 23-item validated questionnaire designed to measure cough-related quality of life. It will take about 5 minutes.
Visual analogue cough severity (VAS): Participants will rate their cough severity on a visual analogue scale by placing a tick mark on a 100 mm line where 0 mm indicates "no cough" and 100 mm indicates "worst possible cough".
WEEKS 2-7: TREATMENT. Participants will attend treatment sessions twice per week for up to six weeks. Participants will use the breathing strategies following inhalation of either the active substance (experimental condition) or repeated exposures to an inactive substance (placebo condition). Participants will do this no more than twelve times per session. Each session will take 45-60 minutes. If a participant misses a treatment session, the investigators will attempt to re-schedule that session. Each participant must complete at least 10 treatment sessions to remain in the study.
WEEKS 8 AND 10: POST-TREATMENT TESTING. Outcome measures, as in the baseline phase, will be taken at one-week and three-weeks post-treatment. The LCQ will be measured again at three-months post-treatment.
- Conditions
- Cough
- Being tested
- Supra-threshold and progressive doses of diluted capsaicin via a dosimeter-controlled nebulizer, Saline
- Keywords
- chronic cough, refractory chronic cough, cough hypersensitivity
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra-threshold and progressive doses of diluted capsaicin via a dosimeter-controlled nebulizerBiological
Participants will be exposured to increasing doses of aerosolized capsaicin (a known cough stimulant) through a dosimeter-controlled nebulizer, while implementing behavioral cough suppression strategies. The concentration of capsaicin will increase incrementally as tolerated, as long as participants are still able to suppress cough. Individual doses will never exceed 1000 micromolar. Cumulative doses per session will never exceed 2000 micromolar. Participants will attend 12 treatment sessions and be given up to 12 exposures per treatment session. Participants will be encouraged to use cough suppression strategies outside of treatment sessions as much as possible to attempt to suppress cough.
SalineBiological
Participants will be repeatedly exposed to a saline through a dosimeter-controlled nebulizer during treatment sessions. Participants will attend 12 treatment sessions and be given up to 12 exposures per treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Supra-threshold capsaicin | Experimental | Arm: Experimental: Supra-threshold capsaicin Participants will be exposed to progressively increasing concentrations of aerosolized capsaicin (the ingredient in chili peppers that makes them spicy, and a known cough stimulant) to stimulate an urge-to-cough. Participants will be coached to implement cough suppression strategies following each exposure. Receives: Biological: Supra-threshold and progressive doses of diluted capsaicin via a dosimeter-controlled nebulizer |
| Arm: Placebo Comparator: Saline | Placebo comparator | Participants will be exposed repeatedly to aerosolized saline through a nebulizer during treatment. Receives: Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Leicester Cough Questionnaire (LCQ) score at 1 week post-treatment
The LCQ is a 23-item validated patient-report questionnaire that takes about 5 minutes to fill out. It results in three domain scores (Social, Psychological, and Physical) and one Total score, which is the sum of the domain scores. Domain scores are between 1 and 7. The total score is between 3 and 21. A higher score means a better outcome.
Measured: The LCQ will be measured before treatment (baseline) and 1 week post treatment
Change from baseline visual analogue cough severity score at 1 week post-treatment
Participant's perceived cough severity will be measured using a visual analogue scale. They will place a tick mark on a 100 mm line where 0mm indicates "no cough problem" and 100 mm indicates "worst possible cough problem".
Measured: Cough severity will be will be measured before treatment (baseline) and 1 week post-treatment
Secondary outcomes (2)
Change from baseline cough-reflex sensitivity at 1 week post-treatment
Cough sensitivity will be measured with cough challenge testing. Standardized procedures that have been established and approved by the FDA will be used. Participants will inhale capsaicin vapor (a known cough stimulant) through a nebulizer with dosimeter, that delivers a specific dose of capsaicin in a mist form. They will inhale doubling doses of capsaicin mist from .49 micromolar to 1000 micromolar. The testing will be stopped when the investigators find the dose that causes five coughs or after giving the 1000 micromolar dose, whichever comes first. This testing will take approximately 30 minutes.
Measured: Cough-reflex sensitivity will be measured before treatment (baseline), and 1 week post-treatment
Change from baseline urge-to-cough (UTC) testing at 1 week post-treatment
During UTC testing, participants will be asked to report their perceived UTC on a scale from 0 (no UTC) to 10 (maximum UTC) after each exposure to capsaicin during cough-reflex sensitivity testing as well as after being presented with the following stimulants/tasks that cause some people to cough: perfume, bleach, laundry soap, fabric softener, vinegar, scented candle, deep and fast breath through the mouth twice in a row, sustained voicing, reading a 55 word passage, and yelling a short phrase. This testing will take about 10 minutes.
Measured: UTC testing will be measured before treatment (baseline) and 1 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 May 2021
- Primary completion30 May 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive the placebo treatment while the second group receives the active treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Slovarp, University of Montana
- Investigators
- Laurie Slovarp, PhD, Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226299
- Sponsor's protocol ID
- UMontana
- Acronym
- CDTPilot2
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Slovarp LJ, Reynolds JE, Tolbert S, Campbell S, Welby S, Morkrid P. Cough desensitization treatment for patients with refractory chronic cough: results of a second pilot randomized control trial. BMC Pulm Med. 2023 Apr 28;23(1):148. doi: 10.1186/s12890-023-02423-6.
PubMed 37118696
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough Desensitization Therapy for Cough Hypersensitivity Syndrome: Pilot 2
- ClinicalTrials.gov ID
- NCT05226299
- Acronym / sponsor ID
- CDTPilot2 / UMontana
- Conditions
- Cough
- Keywords
- chronic cough, refractory chronic cough, cough hypersensitivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 7 Feb 2022 (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 purpose of this study is to investigate a modified behavioral treatment for chronic cough due to cough hypersensitivity syndrome (CHS). This type of CC is a non-productive cough that is due, in part, to over-expression of transient receptor potential vanilliod (TRPV) receptors in the airway epithelium, which contribute to a dry cough elicited by typically non-tussive stimuli (e.g., cold air, smells) or by low doses of tussive stimuli (e.g., smoke). Currently available treatment options are limited to neuromodulator medications (e.g., gabapentin, amytriptiline) and behavioral cough suppression therapy (BCST), neither of which is 100% effective. The primary component of BCST is teaching patients to suppress their cough in the presence of an urge-to-cough. Studies have confirmed a reduction in cough sensitivity (as tested with inhaled capsaicin) following 1-4 weeks of successful cough suppression. However, patients with severe CHS are not able to suppress their cough in the presence of uncontrollable environmental stimuli and, hence, do not respond well to the therapy. The purpose of this study is to determine the potential of treating CHS by implementing BCST while stimulating cough with progressive concentrations of inhaled diluted aerosolized capsaicin. The investigators hypothesize this treatment will result in a reduction in cough-reflex sensitivity, cough-related quality of life, and cough frequency.
Detailed description
The study will be a randomized, placebo-controlled, blinded study. It will take place in three phases, across 10 weeks.
WEEK 1: BASELINE TESTING AND TRAINING (approximate time = 1 hour).
Cough sensitivity testing: Standardized procedures that have been established and approved by the FDA will be used to determine cough sensitivity. Participants will inhale capsaicin vapor (a known cough stimulant) through a nebulizer with dosimeter, that delivers a specific dose of capsaicin in a mist form. They will inhale doubling doses of capsaicin mist from .49 micromolar to 1000 micromolar. The testing will be stopped when the investigators find the dose that causes five coughs or after giving the 1000 micromolar dose, whichever comes first. This testing will take approximately 30 minutes.
Urge-to-cough (UTC) testing: Participants be asked to report their UTC on a scale from 0 (no UTC) to 10 (maximum UTC) after each mist of capsaicin and after being presented with the following stimulants/tasks that cause some people to cough: perfume, bleach, vinegar, wood chips, laundry soap, cleaning wipe, deep and fast breath through the mouth, sustained voicing, reading a 55 word passage, and yelling a short phrase). This testing will take about 10 minutes.
Cough-related quality of life: Participants will complete the Leicester Cough Questionnaire which is a 23-item validated questionnaire designed to measure cough-related quality of life. It will take about 5 minutes.
Visual analogue cough severity (VAS): Participants will rate their cough severity on a visual analogue scale by placing a tick mark on a 100 mm line where 0 mm indicates "no cough" and 100 mm indicates "worst possible cough".
WEEKS 2-7: TREATMENT. Participants will attend treatment sessions twice per week for up to six weeks. Participants will use the breathing strategies following inhalation of either the active substance (experimental condition) or repeated exposures to an inactive substance (placebo condition). Participants will do this no more than twelve times per session. Each session will take 45-60 minutes. If a participant misses a treatment session, the investigators will attempt to re-schedule that session. Each participant must complete at least 10 treatment sessions to remain in the study.
WEEKS 8 AND 10: POST-TREATMENT TESTING. Outcome measures, as in the baseline phase, will be taken at one-week and three-weeks post-treatment. The LCQ will be measured again at three-months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One group will receive the placebo treatment while the second group receives the active treatment.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Supra-threshold capsaicin | Experimental | Biological: Supra-threshold and progressive doses of diluted capsaicin via a dosimeter-controlled nebulizerArm: Experimental: Supra-threshold capsaicin Participants will be exposed to progressively increasing concentrations of aerosolized capsaicin (the ingredient in chili peppers that makes them spicy, and a known cough stimulant) to stimulate an urge-to-cough. Participants will be coached to implement cough suppression strategies following each exposure. |
| Arm: Placebo Comparator: Saline | Placebo comparator | Biological: SalineParticipants will be exposed repeatedly to aerosolized saline through a nebulizer during treatment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age
- Currently suffering from a cough that started at least 8 weeks ago
- Have seen at least one physician for the cough and have received medical treatment without success
- Normal chest x-ray, pulmonary function testing (completed by your physician or a qualified speech-language pathologist).
- Completion of a laryngoscopy (by ENT physician or qualified speech-language pathologist) with no evidence of an anatomical abnormality (i.e., masses or lesions such as nodules, cysts, or cancer) that could contribute to cough.
Key exclusion criteria (19 listed)
- Under 18 years of age
- Positive for COVID-19 or presenting with any of the following symptoms of COVID- 19: fever or chills, sputum, difficulty breathing, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
- Have not followed current local, state, and CDC COVID-19 mitigation guidance, especially regarding travel.
- Unwilling to comply with COVID-19 precautions (see below)
- Currently a smoker of any substance
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 |
|---|---|---|
| Supra-threshold and progressive doses of diluted capsaicin via a dosimeter-controlled nebulizerParticipants will be exposured to increasing doses of aerosolized capsaicin (a known cough stimulant) through a dosimeter-controlled nebulizer, while implementing behavioral cough suppression strategies. The concentration of capsaicin will increase incrementally as tolerated, as long as participants are still able to suppress cough. Individual doses will never exceed 1000 micromolar. Cumulative doses per session will never exceed 2000 micromolar. Participants will attend 12 treatment sessions and be given up to 12 exposures per treatment session. Participants will be encouraged to use cough suppression strategies outside of treatment sessions as much as possible to attempt to suppress cough. | Biological | Experimental: Supra-threshold capsaicin |
| SalineParticipants will be repeatedly exposed to a saline through a dosimeter-controlled nebulizer during treatment sessions. Participants will attend 12 treatment sessions and be given up to 12 exposures per treatment session. | Biological | Arm: Placebo Comparator: Saline |
Primary outcome
Change from baseline Leicester Cough Questionnaire (LCQ) score at 1 week post-treatment
Time frame: The LCQ will be measured before treatment (baseline) and 1 week post treatment
The LCQ is a 23-item validated patient-report questionnaire that takes about 5 minutes to fill out. It results in three domain scores (Social, Psychological, and Physical) and one Total score, which is the sum of the domain scores. Domain scores are between 1 and 7. The total score is between 3 and 21. A higher score means a better outcome.
Change from baseline visual analogue cough severity score at 1 week post-treatment
Time frame: Cough severity will be will be measured before treatment (baseline) and 1 week post-treatment
Participant's perceived cough severity will be measured using a visual analogue scale. They will place a tick mark on a 100 mm line where 0mm indicates "no cough problem" and 100 mm indicates "worst possible cough problem".
2 secondary outcomes
Change from baseline cough-reflex sensitivity at 1 week post-treatment
Time frame: Cough-reflex sensitivity will be measured before treatment (baseline), and 1 week post-treatment
Change from baseline urge-to-cough (UTC) testing at 1 week post-treatment
Time frame: UTC testing will be measured before treatment (baseline) and 1 week post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 37118696Slovarp LJ, Reynolds JE, Tolbert S, Campbell S, Welby S, Morkrid P. Cough desensitization treatment for patients with refractory chronic cough: results of a second pilot randomized control trial. BMC Pulm Med. 2023 Apr 28;23(1):148. doi: 10.1186/s12890-023-02423-6.
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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. This study is not recruiting at the moment.
Laurie Slovarp, PhD principal investigator
University of Montana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saline in people with Cough, run by University of Montana 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 9 inclusion and 19 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: finished, as of the sponsor's last update on 3 Nov 2022. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Leicester Cough Questionnaire (LCQ) score at 1 week post-treatment (time frame: The LCQ will be measured before treatment (baseline) and 1 week post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226299, which also lists 1 linked publication.
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 3 Nov 2022.