Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip

Post Nasal Drip Clinical Trial

Official title:

Capsaicin Cough Sensitivity, Airway Inflammation and Neurogenic Peptides in Chronic Cough Associated With Postnasal Drip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588627
• Other study ID #: 2251-05
• Secondary ID: CR-20
• Status: Completed
• Phase: Phase 2
• First received: December 25, 2007
• Last updated: March 8, 2010
• Start date: March 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Post Nasal Drip

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Endpoint	No
Secondary	We hypothesize that neurogenic inflammation is increased in patients with PND-CC compared to subjects with PND alone.		Endpoint	No
Secondary	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.		Endpoint	No

External Links

•   Mayo Clinic Clinical Trials