AsthmaNCT00173225
Sputum and Plasma Levels of Nociceptin and Substance P in Patients With Asthma, COPD and Chronic Cough
An observational study of Asthma and COPD, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jun 2005
- 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
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:patients with asthma, COPD, chronic cough
-
Exclusion Criteria:patients refusing blood sampling
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ping-Hung Kuo
Taipei, 100
Ping-Hung Kuo, MD, 886-2-23123456 ext. 3075, kph@ntumc.org
Ping-Hung Kuo, MD
About this study
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
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.
Read the 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.
- Keywords
- nociceptin, sunstance P, asthma, COPD, cough
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Cough
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ping-Hung Kuo, MD, Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173225
- Sponsor's protocol ID
- 9461700531
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00173225
- Acronym / sponsor ID
- 9461700531
- Keywords
- nociceptin, sunstance P, asthma, COPD, cough
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jun 2005
- First posted
- 15 Sep 2005 (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.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Ping-Hung Kuo, MD principal investigator
Department of Internal Medicine, National Taiwan University Hospital
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 Asthma and COPD, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping-Hung Kuo, MD (886-2-23123456 ext. 3075, kph@ntumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Sep 2005.