Clinical Phenotypes of COPD Patients Between in Plateau and Plain

NCT04964076 | Completed

• 1 other identifier: LM2020390
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (7)

• Assessment of respiratory symptoms

  COPD Assessment Test

  Data were obtained during the interview.

• Exacerbation

  Frequency of exacerbations in the past year

  Data were obtained during the interview.

• Spirometry testing

  FEV1 %predicted, FVC %predicted, ratio of FEV1/FVC

  Data were obtained during the interview.

• Emphysema

  The percentage of the LAA divided by total lung volumes (LAA%) was used as an index of the severity of emphysema in quantitative CT examination.

  Within 3 months of the interview.

• Airway remodeling -1

  Bronchial wall thickness (WT, mm) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.

  Within 3 months of the interview.

• Airway remodeling -2

  Luminal area (LA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.

  Within 3 months of the interview.

• Airway remodeling -3

  Bronchial wall area (WA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.

  Within 3 months of the interview.

Study Arms (2)

COPD patients in the plateau

We consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Tibet Autonomous Region People's Hospital from January 2018 to December 2021.

Other: No intervention

COPD patients in the plain

We consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Peking University Third Hospital from January 2018 to December 2021.

Other: No intervention

Interventions

No intervention OTHER

No intervention

COPD patients in the plain; COPD patients in the plateau

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We consecutively enrolled patients with COPD from January 2018 to December 2021, who visited the outpatient of Department of Respiratory Medicine in Peking University Third Hospital or Tibet Autonomous Region People's Hospital.

You may qualify if:

• meeting the diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC)\<0.7.

You may not qualify if:

• age \<40 years;
• subjects with airway diseases other than COPD;
• acute exacerbation of COPD in the past 3 months;
• active tuberculosis;
• cardiovascular or cerebrovascular events in the past 3 months;
• cognitive dysfunction such as vascular dementia or Alzheimer's disease;
• refusal to participate in this study.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Tibet Autonomous Region People's Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongchang Sun, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University Third Hospital

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 15, 2021
• Study Start: November 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)