Chronic CoughNCT01807832
The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
A study testing capsaicin challenge in people with Chronic Cough, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The purpose of this study is to determine whether the capsaicin challenge can improve the diagnosis, treatment, monitoring and follow-up in patients with chronic cough. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Cough
- What is being tested?
- capsaicin challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with persisting cough for more than 3 months, without known respiratory or lung diseases
Who cannot join
- Diagnosis of respiratory or lung diseases of any kind
About this study
The purpose of this study is to determine whether the capsaicin challenge can improve the diagnosis, treatment, monitoring and follow-up in patients with chronic cough.
Read the detailed description
Capsaicin is administrated in incremental concentrations with two inhalations of normal saline solution. Patients are instructed to exhale to functional residual capacity and than to inhale through the mouthpiece for 1 second (single breath inhalation). The number of coughs in the first 10 seconds after each inhalation is counted. C2; the concentration of which the patient responded by 2 coughs, C5;the concentration of which the patient responded by 5 coughs. The challenge ends at C5.
- Conditions
- Chronic Cough
- Being tested
- capsaicin challenge
- Keywords
- chronic cough, cough reflex hypersensitivity, capsaicin
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsaicin challengeOther
| Study group | Role | What they receive |
|---|---|---|
| chronic cough | Other | Capsaicine challenge in chronic cough patients Receives: Other: capsaicin challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough reflex hypersensitivity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807832
- Sponsor's protocol ID
- TASMC-13-LF-0695-CTIL
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
- ClinicalTrials.gov ID
- NCT01807832
- Acronym / sponsor ID
- TASMC-13-LF-0695-CTIL
- Conditions
- Chronic Cough
- Keywords
- chronic cough, cough reflex hypersensitivity, capsaicin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Mar 2013 (estimated)
- 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 determine whether the capsaicin challenge can improve the diagnosis, treatment, monitoring and follow-up in patients with chronic cough.
Detailed description
Capsaicin is administrated in incremental concentrations with two inhalations of normal saline solution. Patients are instructed to exhale to functional residual capacity and than to inhale through the mouthpiece for 1 second (single breath inhalation). The number of coughs in the first 10 seconds after each inhalation is counted. C2; the concentration of which the patient responded by 2 coughs, C5;the concentration of which the patient responded by 5 coughs. The challenge ends at C5.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic cough | Other | Other: capsaicin challengeCapsaicine challenge in chronic cough patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with persisting cough for more than 3 months, without known respiratory or lung diseases
Key exclusion criteria (1 listed)
- Diagnosis of respiratory or lung diseases of any kind
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 |
|---|---|---|
| capsaicin challenge | Other | chronic cough |
Primary outcome
cough reflex hypersensitivity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing capsaicin challenge in people with Chronic Cough, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
cough reflex hypersensitivity (time frame: 3 months). 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 8 Mar 2013.