Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588627
First received: December 25, 2007
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

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.


Condition Phase
Post Nasal Drip
Phase 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Capsaicin Cough Sensitivity, Airway Inflammation and Neurogenic Peptides in Chronic Cough Associated With Postnasal Drip

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We hypothesize that neurogenic inflammation is increased in patients with PND-CC compared to subjects with PND alone. [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Mucus will be quantified and protease inhibitors will be added after collection. The specimen will be coded to deidentify. It will be transported to laboratory for storage and analysis. The mucus collected from the posterior nasopharynx will be frozen and assayed simultaneously. Substance P and Neurokinin A will be measured by ELISA at the end of the study period.


Enrollment: 25
Study Start Date: March 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Post Nasal Drip and chronic cough
2
Post nasal drip and no 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic, community samples

Criteria

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588627

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kaiser G. Lim, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Kaiser G. Lim, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588627     History of Changes
Other Study ID Numbers: 2251-05, CR-20
Study First Received: December 25, 2007
Last Updated: March 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Chronic cough
Post nasal drip

ClinicalTrials.gov processed this record on October 21, 2014