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CompletedNCT00588627Updated Mar 10, 2010

Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip

An observational study in Post Nasal Drip, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-10.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Post Nasal Drip

Keywords

  • Chronic cough
  • Post nasal drip
03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 25 is below the median of 94 across 75 observational studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic, community samples

Inclusion criteria

-

Postnasal Drip with chronic cough:

  1. Postnasal drip by rhinoscopy
  2. Cough by visual analog scale.
  3. Patients have to be 18 years old or older.
  4. 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.
  5. Subjects must have a negative chest radiogram or Chest CT scan within 6 months.
  6. No active GERD symptoms (\< 7 RSI score) \& a stable dose of Proton Pump Inhibitor (4 weeks).

    Eligibility Criteria of Postnasal Drip without cough:

  7. Postnasal drip by rhinoscopy
  8. No cough by visual analog scale.
  9. Patients have to be 18 years old or older.

Exclusion criteria

Exclusion Criteria:

  • Subject Exclusion Criteria for Postnasal Drip with Chronic Cough:

    1. Presence of nasal polyposis and/or sinusitis or active GERD symptoms on examination.
    2. Current smokers (smoking within the 2 months prior to the study) will be excluded.
    3. Patients with an upper respiratory tract infection within the preceding 8 weeks.
    4. Patients taking angiotensin converting enzyme inhibitors.
    5. 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.

Exclusion Criteria: Same for Post Nasal Drip without cough except:

  1. A chest radiogram is not necessary in this group.
  2. Patients taking leukotriene inhibitors, or using nasal steroid therapy.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 1

    Post Nasal Drip and chronic cough

  • 2

    Post nasal drip and no cough

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. We hypothesize that neurogenic inflammation is increased in patients with PND-CC compared to subjects with PND alone.

    Time frame: Endpoint

  2. 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

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00588627
Lead sponsor
Mayo Clinic
First posted
Jan 8, 2008
Start date
Mar 2006
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Mar 10, 2010

Study contacts

Kaiser G. Lim, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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