CoughEarly Phase 1NCT04256733
Cough Desensitization Therapy for Cough Hypersensitivity Syndrome
A Early Phase 1 study testing Supra-threshold and progressive doses of diluted capsaicin via a Koko Digidoser nebulizer and Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer 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?
- Supra-threshold and progressive doses of diluted capsaicin via a Koko Digidoser nebulizer and Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 13 Feb 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, and laryngoscopy (laryngoscopy completed by your physician or the speech-language pathologist)
- Have undergone behavioral cough suppression therapy without full resolution of cough
- Willing to take a pregnancy test before enrollment (if applicable)
- Willing to use contraception during the study (if applicable)
- Willing to sign an informed consent form
Who cannot join
- Under 18 years of age
- Currently a smoker of any substance
- Pregnant or attempting to become pregnant
- Diagnosed with a respiratory or pulmonary condition (e.g., asthma, COPD, emphysema, lung cancer, bronchitis)
- 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/Aceonm, quinapril/Accupril, trandolapril/Mavik
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Cough Reflex Desensitization for the Treatment of Cough Hypersensitivity Syndrome
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 7 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.
- Cough suppression training. Participants will be trained in cough suppression strategies. These strategies include 1) relaxed throat breathing where they inhale quickly through the nose and exhale through tightly pursed lips, and 2) cough suppression swallow, which involves swallowing saliva or a sip of water with as much effort as possible and while pressing hands together tightly. This training will take approximately 15 minutes.
- Cough frequency testing: Participants will carry a small audio recording device with a small microphone that attaches to the participant's shirt for 24 hours. The recording device will be in a small carrying case (about half the size of a typical cell phone) that can clip to a belt or waistband. Participants will return the recording device to the investigators at or before the first treatment visit (see below). The audio recording will be analyzed by computer software that counts the number of coughs in the 24-hour period. (NOTE: The audio recording will not be listened to by any PERSON and the recording will be deleted after it is analyzed by the computer software.) (Following baseline testing, participants will be randomly assigned to either the treatment group or placebo group.)
WEEKS 2-4: TREATMENT. Participants will attend treatment sessions twice per week for three weeks. Participants will use the breathing strategies following inhalation of either progressive doses of diluted capsaicin (experimental condition) or repeated exposures to a single sub-threshold concentration of diluted capsaicin (placebo condition). Participants will do this no more than twelve times per session. Each session will take approximately 45 minutes. If a participant misses a treatment session, the investigators will attempt to re-schedule that session. Each participant must complete at least five of treatment sessions to remain in the study.
WEEKS 5 AND 7: POST-TREATMENT TESTING. Outcome measures, as in the baseline phase, will be take 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 Koko Digidoser nebulizer, Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer
- Keywords
- chronic cough, refractory chronic cough, cough hypersensitivity syndrome
- Medical subject headings
- Cough, Chronic Cough, cough hypersensitivity syndrome
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 Koko Digidoser nebulizerBiological
Participants will be exposured to increasing doses of aerosolized capsaicin (a known cough stimulant) through the Koko Digidoser 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. The concentration will never exceed 1000 micromolar. Participants will attend 6 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.
Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizerBiological
Participants will be repeatedly exposed to a sub-threshold dose of aerosolized capsaicin through the KoKo Digidoser nebulizer during treatment sessions. Participants will attend 6 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.
| Study group | Role | What they receive |
|---|---|---|
| Supra-threshold capsaicin | Experimental | 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 Koko Digidoser nebulizer |
| Sub-threshold capsaicin | Placebo comparator | Participants will be exposed repeatedly to a single sub-threshold dose of aerosolized capsaicin through a nebulizer during treatment. This sub-threshold dose will elicit minimal or no urge-to-cough. Receives: Biological: Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leicester Cough Questionnaire (LCQ)
The Leicester Cough Questionnaire (LCQ) is a 19-item validated patient-report questionnaire that measures the impact of cough on quality of life. It takes about 5 minutes to complete and results in three domain scores (Social, Psychological, and Physical), and one Total score. Domain scores are averages of the questions that make up each domain. Minimum and maximum domain scores are 1 and 7, respectively. The domain scores are summed to determine the Total score, which can range from 3 to 21. A higher score means less impact on quality of life. The change in LCQ was determined by subtracting the Total LCQ score at baseline from the Total LCQ score at 3 weeks post-treatment. A positive LCQ change score indicates an improvement.
Measured: The LCQ will be measured before treatment and three weeks following treatment
Secondary outcomes (2)
Urge-to-Cough Testing
Urge-to-cough (UTC) testing involves presenting participants to various scents and vocal and breathing tasks (12 tasks in total) and asking them to rate their maximum perceived UTC on a scale from 0 (no UTC) to 10 (maximum UTC). The UTC score for each testing session is the sum of the the UTC scores from each individual task. This results in a possible score range from 0 (no UTC on any tasks) to 120 (score of 10 on every UTC task). UTC change is determined by subtracting the UTC score on each task at baseline from the UTC score for each task at 3 weeks post-treatment and then summing those scores. A negative UTC change score indicates the UTC score was lower post-treatment relative to baseline, which indicates an improvement.
Measured: Urge-to-cough will be measured before treatment and three weeks following the final treatment session
Urge-to-Cough Testing: Cough Frequency
During UTC testing, participants are exposed to various scents and vocal and breathing tasks and the number of coughs elicited during and immediately following each task are counted. A cough frequency score for each testing session is the sum of the number of coughs counted during each task. Change in cough frequency is calculated by subtracting the baseline cough frequency from the 3 week post-treatment cough frequency. A negative score indicates cough frequency was less after treatment, which indicates an improvement.
Measured: Baseline and 3 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 May 2019
- Primary completion30 Nov 2020
- Study completion13 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Early 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 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 J Slovarp, PhD, Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256733
- Sponsor's protocol ID
- 188-88
- Status last verified
- Aug 2023
- First submitted
- 24 Sep 2019
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slovarp L, Reynolds JE, Bozarth-Dailey E, Popp S, Campbell S, Morkrid P. Cough desensitization treatment: A randomized, sham-controlled pilot trial for patients with refractory chronic cough. Respir Med. 2022 Mar;193:106739. doi: 10.1016/j.rmed.2022.106739. Epub 2022 Jan 15.
PubMed 35091204
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cough Reflex Desensitization for the Treatment of Cough Hypersensitivity Syndrome
- ClinicalTrials.gov ID
- NCT04256733
- Acronym / sponsor ID
- 188-88
- Conditions
- Cough
- Keywords
- chronic cough, refractory chronic cough, cough hypersensitivity syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 13 Feb 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 4 Mar 2024
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 7 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.
- Cough suppression training. Participants will be trained in cough suppression strategies. These strategies include 1) relaxed throat breathing where they inhale quickly through the nose and exhale through tightly pursed lips, and 2) cough suppression swallow, which involves swallowing saliva or a sip of water with as much effort as possible and while pressing hands together tightly. This training will take approximately 15 minutes.
- Cough frequency testing: Participants will carry a small audio recording device with a small microphone that attaches to the participant's shirt for 24 hours. The recording device will be in a small carrying case (about half the size of a typical cell phone) that can clip to a belt or waistband. Participants will return the recording device to the investigators at or before the first treatment visit (see below). The audio recording will be analyzed by computer software that counts the number of coughs in the 24-hour period. (NOTE: The audio recording will not be listened to by any PERSON and the recording will be deleted after it is analyzed by the computer software.) (Following baseline testing, participants will be randomly assigned to either the treatment group or placebo group.)
WEEKS 2-4: TREATMENT. Participants will attend treatment sessions twice per week for three weeks. Participants will use the breathing strategies following inhalation of either progressive doses of diluted capsaicin (experimental condition) or repeated exposures to a single sub-threshold concentration of diluted capsaicin (placebo condition). Participants will do this no more than twelve times per session. Each session will take approximately 45 minutes. If a participant misses a treatment session, the investigators will attempt to re-schedule that session. Each participant must complete at least five of treatment sessions to remain in the study.
WEEKS 5 AND 7: POST-TREATMENT TESTING. Outcome measures, as in the baseline phase, will be take 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
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- One group will receive the placebo treatment while the second group receives the active treatment.
| Arm | Type | Receives |
|---|---|---|
| Supra-threshold capsaicin | Experimental | Biological: Supra-threshold and progressive doses of diluted capsaicin via a Koko Digidoser nebulizerParticipants 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. |
| Sub-threshold capsaicin | Placebo comparator | Biological: Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizerParticipants will be exposed repeatedly to a single sub-threshold dose of aerosolized capsaicin through a nebulizer during treatment. This sub-threshold dose will elicit minimal or no urge-to-cough. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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, and laryngoscopy (laryngoscopy completed by your physician or the speech-language pathologist)
- Have undergone behavioral cough suppression therapy without full resolution of cough
Key exclusion criteria (5 listed)
- Under 18 years of age
- Currently a smoker of any substance
- Pregnant or attempting to become pregnant
- Diagnosed with a respiratory or pulmonary condition (e.g., asthma, COPD, emphysema, lung cancer, bronchitis)
- 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/Aceonm, quinapril/Accupril, trandolapril/Mavik
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 Koko Digidoser nebulizerParticipants will be exposured to increasing doses of aerosolized capsaicin (a known cough stimulant) through the Koko Digidoser 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. The concentration will never exceed 1000 micromolar. Participants will attend 6 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 | Supra-threshold capsaicin |
| Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizerParticipants will be repeatedly exposed to a sub-threshold dose of aerosolized capsaicin through the KoKo Digidoser nebulizer during treatment sessions. Participants will attend 6 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 | Sub-threshold capsaicin |
Primary outcome
Leicester Cough Questionnaire (LCQ)
Time frame: The LCQ will be measured before treatment and three weeks following treatment
The Leicester Cough Questionnaire (LCQ) is a 19-item validated patient-report questionnaire that measures the impact of cough on quality of life. It takes about 5 minutes to complete and results in three domain scores (Social, Psychological, and Physical), and one Total score. Domain scores are averages of the questions that make up each domain. Minimum and maximum domain scores are 1 and 7, respectively. The domain scores are summed to determine the Total score, which can range from 3 to 21. A higher score means less impact on quality of life. The change in LCQ was determined by subtracting the Total LCQ score at baseline from the Total LCQ score at 3 weeks post-treatment. A positive LCQ change score indicates an improvement.
2 secondary outcomes
Urge-to-Cough Testing
Time frame: Urge-to-cough will be measured before treatment and three weeks following the final treatment session
Urge-to-Cough Testing: Cough Frequency
Time frame: Baseline and 3 weeks post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35091204Slovarp L, Reynolds JE, Bozarth-Dailey E, Popp S, Campbell S, Morkrid P. Cough desensitization treatment: A randomized, sham-controlled pilot trial for patients with refractory chronic cough. Respir Med. 2022 Mar;193:106739. doi: 10.1016/j.rmed.2022.106739. Epub 2022 Jan 15.
- Individual participant dataSharing planned: No
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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 J 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 Early Phase 1 study testing Supra-threshold and progressive doses of diluted capsaicin via a Koko Digidoser nebulizer and Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer 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 8 inclusion and 5 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 4 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Leicester Cough Questionnaire (LCQ) (time frame: The LCQ will be measured before treatment and three weeks following treatment). 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 NCT04256733, 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 4 Mar 2024.