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Sputum and Plasma Levels of Nociceptin and Substance P in Patients With Asthma, COPD and Chronic Cough

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00173225
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
The aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance P with cough severity and airway hyperreactivity in patients with asthma, COPD and chronic cough.

Condition
Asthma COPD Cough

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Association Between Sputum and Plasma Levels of Nociceptin and Substance P With Cough Severity and Airway Hyperreactivity in Patients With Asthma, COPD and Chronic Cough

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 300
Study Start Date: June 2005
Estimated Study Completion Date: June 2005
Detailed Description:
Recent animal studies have found that nociceptin can inhibit cough responses induced by capsaicin. We hypothesize that sputum and plasma levels of these peptides may reflect some neurochemical alterations in airway cough reflex or neurogenic inflammation in asthma or COPD. The aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance P with cough severity and airway hyperreactivity in patients with asthma, COPD and chronic cough. We will enroll 260 patients (100 patients with asthma, 60 with COPD and 100 with chronic cough) as well as 40 healthy subjects for this study. Sputum and peripheral blood will be collected and concentrations of nociceptin and substance P will be measured by ELISA. These levels will be correlated with cough severity (symptom scores), and airway hyperresponsiveness to inhaled methacholine as measured by PC20. Sputum and plasma concentrations of both peptides will be rechecked after clinical improvements in cough or airway symptoms are achieved after therapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:patients with asthma, COPD, chronic cough

Exclusion Criteria:patients refusing blood sampling

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173225


Contacts
Contact: Ping-Hung Kuo, MD 886-2-23123456 ext 3075 kph@ntumc.org

Locations
Taiwan
Ping-Hung Kuo Recruiting
Taipei, Taiwan, 100
Contact: Ping-Hung Kuo, MD    886-2-23123456 ext 3075    kph@ntumc.org   
Principal Investigator: Ping-Hung Kuo, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ping-Hung Kuo, MD Department of Internal Medicine, National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00173225     History of Changes
Other Study ID Numbers: 9461700531
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
Last Verified: June 2005

Keywords provided by National Taiwan University Hospital:
nociceptin
sunstance P
asthma
COPD
cough

Additional relevant MeSH terms:
Asthma
Cough
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Substance P
Neurokinin A
Nociceptin
Nocistatin
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents