Post Nasal DripNCT00588627
Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip
An observational study of Post Nasal Drip, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to find out why some people with mucus dripping down the back of their throat have a nagging cough while others do not cough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Nasal Drip
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic, community samples
Who may be able to join
- -
- Postnasal Drip with chronic cough:
- Postnasal drip by rhinoscopy
- Cough by visual analog scale.
- Patients have to be 18 years old or older.
- Cough-variant asthma must be excluded by a negative methacholine challenge test within one year, or documented failure of chronic cough to resolve after administration of inhaled corticosteroid (> one-month duration). Asthma is defined by the ATS guidelines.
Show all 12Show fewer
- Subjects must have a negative chest radiogram or Chest CT scan within 6 months.
- No active GERD symptoms (< 7 RSI score) \& a stable dose of Proton Pump Inhibitor (4 weeks).
- Eligibility Criteria of Postnasal Drip without cough:
- Postnasal drip by rhinoscopy
- No cough by visual analog scale.
- Patients have to be 18 years old or older.
Who cannot join
- Subject Exclusion Criteria for Postnasal Drip with Chronic Cough:
- Presence of nasal polyposis and/or sinusitis or active GERD symptoms on examination.
- Current smokers (smoking within the 2 months prior to the study) will be excluded.
- Patients with an upper respiratory tract infection within the preceding 8 weeks.
- Patients taking angiotensin converting enzyme inhibitors.
- Patients on leukotriene receptor antagonist and/ or nasal topical corticosteroids or inhaled corticosteroids. Patient must be off nasal or inhaled corticosteroid by at least 4 weeks.
Show all 9Show fewer
- Exclusion Criteria: Same for Post Nasal Drip without cough except:
- A chest radiogram is not necessary in this group.
- Patients taking leukotriene inhibitors, or using nasal steroid therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capsaicin Cough Sensitivity, Airway Inflammation and Neurogenic Peptides in Chronic Cough Associated With Postnasal Drip
This study is being done to find out why some people with mucus dripping down the back of their throat have a nagging cough while others do not cough.
Read the detailed description
The objective of the protocol is to determine the pathogenesis of cough in diseases of the aerodigestive tract. There were over 24 million ambulatory chronic cough visits nationally in 1991 and over 8,000 visits in 2004 at MCR. Current guidelines for chronic cough are based on case series and on empirical expert opinions. Studies have implicated mucosal inflammation, heightened sensitivity of capsaicin cough receptors on peripheral nerves and elaboration of inflammatory mediators including tussigenic neuropeptides. There are gaps in our knowledge of what triggers cough in many disease states. For example, postnasal drip syndrome has been estimated to account for 70% of chronic cough, yet it is known that not all patients with postnasal drip have chronic cough. Our hypothesis is that there must be critical factor/s that cause cough in one patient with postnasal drip but not in another. This study will evaluate whether there exists differences in capsaicin cough sensitivity, neuropeptides levels and mucosal inflammation in patients with postnasal drip and chronic cough and compared to its natural control group, subjects with postnasal drip with and without chronic cough. After standard therapy to eliminate postnasal drip, repeat measurement of capsaicin sensitivity and nitric oxide levels will be obtained. There is a critical need to determine the mechanisms underlying cough for better management. The study results will provide insight and fill gaps in our knowledge and will serve to advance future work evaluating mechanisms of cough in other disease states including asthma, GERD, interstitial lung disease and smokers.
- Conditions
- Post Nasal Drip
- Keywords
- Chronic cough, Post nasal drip
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Post Nasal Drip and chronic cough | |
| 2 | Post nasal drip and no cough |
What is being measured
The primary outcome is the main question the study is designed to answer.
We hypothesize that capsaicin cough sensitivity is increased in patients with PND-CC compared to subjects with PND without cough and that cough sensitivity to capsaicin will decrease with treatment for postnasal drip.
Measured: Endpoint
Secondary outcomes (2)
We hypothesize that neurogenic inflammation is increased in patients with PND-CC compared to subjects with PND alone.
Measured: Endpoint
We hypothesize that nasal mucosal inflammation is increased in patients with PND-CC compared to subjects with PND alone, and that nasal mucosal inflammation will be decreased following treatment for postnasal treatment.
Measured: Endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Nasal DripStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Kaiser G. Lim, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588627
- Sponsor's protocol ID
- 2251-05
- Other IDs
- CR-20
- Status last verified
- Mar 2010
- First submitted
- 25 Dec 2007
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsaicin Cough Sensitivity, Airway Inflammation and Neurogenic Peptides in Chronic Cough Associated With Postnasal Drip
- ClinicalTrials.gov ID
- NCT00588627
- Acronym / sponsor ID
- 2251-05
- Conditions
- Post Nasal Drip
- Keywords
- Chronic cough, Post nasal drip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Jan 2008 (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.
This study is being done to find out why some people with mucus dripping down the back of their throat have a nagging cough while others do not cough.
Detailed description
The objective of the protocol is to determine the pathogenesis of cough in diseases of the aerodigestive tract. There were over 24 million ambulatory chronic cough visits nationally in 1991 and over 8,000 visits in 2004 at MCR. Current guidelines for chronic cough are based on case series and on empirical expert opinions. Studies have implicated mucosal inflammation, heightened sensitivity of capsaicin cough receptors on peripheral nerves and elaboration of inflammatory mediators including tussigenic neuropeptides. There are gaps in our knowledge of what triggers cough in many disease states. For example, postnasal drip syndrome has been estimated to account for 70% of chronic cough, yet it is known that not all patients with postnasal drip have chronic cough. Our hypothesis is that there must be critical factor/s that cause cough in one patient with postnasal drip but not in another. This study will evaluate whether there exists differences in capsaicin cough sensitivity, neuropeptides levels and mucosal inflammation in patients with postnasal drip and chronic cough and compared to its natural control group, subjects with postnasal drip with and without chronic cough. After standard therapy to eliminate postnasal drip, repeat measurement of capsaicin sensitivity and nitric oxide levels will be obtained. There is a critical need to determine the mechanisms underlying cough for better management. The study results will provide insight and fill gaps in our knowledge and will serve to advance future work evaluating mechanisms of cough in other disease states including asthma, GERD, interstitial lung disease and smokers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Post Nasal Drip and chronic cough |
| 2 | – | –Post nasal drip and no cough |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, community samples
Key inclusion criteria (12 listed)
- -
- Postnasal drip by rhinoscopy
- Cough by visual analog scale.
- Patients have to be 18 years old or older.
- Cough-variant asthma must be excluded by a negative methacholine challenge test within one year, or documented failure of chronic cough to resolve after administration of inhaled corticosteroid (> one-month duration). Asthma is defined by the ATS guidelines.
Key exclusion criteria (9 listed)
- Subject Exclusion Criteria for Postnasal Drip with Chronic Cough:
- A chest radiogram is not necessary in this group.
- Patients taking leukotriene inhibitors, or using nasal steroid therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We hypothesize that capsaicin cough sensitivity is increased in patients with PND-CC compared to subjects with PND without cough and that cough sensitivity to capsaicin will decrease with treatment for postnasal drip.
Time frame: Endpoint
2 secondary outcomes
We hypothesize that neurogenic inflammation is increased in patients with PND-CC compared to subjects with PND alone.
Time frame: Endpoint
We hypothesize that nasal mucosal inflammation is increased in patients with PND-CC compared to subjects with PND alone, and that nasal mucosal inflammation will be decreased following treatment for postnasal treatment.
Time frame: Endpoint
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 10 Mar 2010.
Related trials for Post Nasal Drip
Recruiting
Upper Airway's Pressure Drop Analyses After Mandibular Advancement and Maxillary Expansion
Apnea, Airway Obstruction, Nasal
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.
Kaiser G. Lim, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Nasal Drip, run by Mayo Clinic 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 12 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: finished, as of the sponsor's last update on 10 Mar 2010. 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. 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?
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?
We hypothesize that capsaicin cough sensitivity is increased in patients with PND-CC compared to subjects with PND without cough and that cough sensitivity to capsaicin will decrease with treatment for postnasal drip. (time frame: Endpoint). 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 10 Mar 2010.