Prospective study for the association between productive cough and mucus plugs in the pathogenesis of chronic obstructive pulmonary disease (COPD)

Prospective study for the association between productive cough and mucus plugs in the pathogenesis of chronic obstructive pulmonary disease (COPD) - Prospective study for the association between productive cough and mucus plugs in the pathogenesis of chronic obstructive pulmonary disease (COPD)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055706

Enrollment

250

Registered

2024-11-01

Start date

2024-11-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic obstructive pulmonary disease (COPD)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are visiting the research institution 2. Patients who have been definitively diagnosed with COPD and are currently undergoing treatment 3. Patients who are 20 years of age or older on the day of enrollment 4. Patients who have given written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients with other obvious respiratory diseases such as lung cancer or interstitial lung disease 2. Pregnant or breastfeeding patients 3. Other patients who the principal investigator/researcher deems inappropriate as study subjects

Design outcomes

Primary

Measure	Time frame
To compare the frequency of COPD exacerbations and deaths among patients with wet cough, those with dry cough, and those without cough.	—

Secondary

Measure	Time frame
We will compare chest CT mucus plug scores, emphysema scores, degree of airway wall thickness, frequency of sinusitis, frequency of heart disease, BNP values, peripheral blood eosinophil/neutrophil counts, non-specific IgE, presence or absence of allergen sensitization, serum biomarkers (IL-8, IL-33, etc.), exhaled NO value, and pulmonary function in patients with wet cough, dry cough, and no cough. We will also analyze changes in these clinical indicators and the incidence of COPD exacerbations, hospitalization rates, and mortality rates during the observation period. In cases who were able to expectorate sputum (mainly the group with wet cough), we will analyze the types of bacterial flora in sputum cultures and the incidence of COPD exacerbations, hospitalization rates, and mortality rates. In addition, only in cases where testing was possible, we will analyze the relationship between capsaicin cough sensitivity, cell fractions in induced sputum, biomarkers in sputum supernatant (IL-8, IL-33, etc.) and the incidence of COPD exacerbations during the observation period, hospitalization rate, mortality rate, mucus plug score on chest CT, emphysema score, airway wall thickness, presence or absence of allergen sensitization, serum biomarkers (IL-8, IL-33, etc.), exhaled NO value, lung function, etc.	—

Measure

Time frame

We will compare chest CT mucus plug scores, emphysema scores, degree of airway wall thickness, frequency of sinusitis, frequency of heart disease, BNP values, peripheral blood eosinophil/neutrophil counts, non-specific IgE, presence or absence of allergen sensitization, serum biomarkers (IL-8, IL-33, etc.), exhaled NO value, and pulmonary function in patients with wet cough, dry cough, and no cough. We will also analyze changes in these clinical indicators and the incidence of COPD exacerbations, hospitalization rates, and mortality rates during the observation period. In cases who were able to expectorate sputum (mainly the group with wet cough), we will analyze the types of bacterial flora in sputum cultures and the incidence of COPD exacerbations, hospitalization rates, and mortality rates. In addition, only in cases where testing was possible, we will analyze the relationship between capsaicin cough sensitivity, cell fractions in induced sputum, biomarkers in sputum supernatant (IL-8, IL-33, etc.) and the incidence of COPD exacerbations during the observation period, hospitalization rate, mortality rate, mucus plug score on chest CT, emphysema score, airway wall thickness, presence or absence of allergen sensitization, serum biomarkers (IL-8, IL-33, etc.), exhaled NO value, lung function, etc.

—

Countries

Japan

Contacts

Public ContactKensuke Fukumitsu

Nagoya City University Graduate School of Medical Sciences Department of Respiratory Medicine, Allergy and Clinical Immunology

k-fkmt@med.nagoya-cu.ac.jp052-853-8216

Outcome results