Air Purifier Use and Respiratory Health in COPD Patients

NCT07505602 | Recruiting

• 1 other identifier: FDUEH-11
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, parallel-controlled trial aims to evaluate the effects of an indoor air purifier intervention on respiratory health in patients with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

Respiratory Health

Keywords

Chronic Obstructive Pulmonary Disease; Air purifier; Randomized controlled trial; Respiratory health

Outcome Measures

Primary Outcomes (3)

• Changes in the percentage of low attenuation area at -950 Hounsfield units (%LAA-950)

  %LAA-950 was defined as the percentage of voxels with attenuation lower than -950 Hounsfield units. A higher percentage reflects more severe emphysematous destruction of lung tissue.

  Baseline and after the completion of the intervention period (12 months anticipated)

• Changes of wall area percentage (WA%)

  Airway wall thickness was calculated as the mean percentage of wall area (WA%) of prespecified segmental and subsegmental bronchi from each lung lobe.

  Baseline and after the completion of the intervention period (12 months anticipated)

• Changes of forced expiratory volume in 1 s (FEV1)

  The pulmonary function measures are performed by a professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject is in a sitting position and clamps the nose clip, and repeats the test, with the best result as the criterion.

  Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

Secondary Outcomes (3)

• Changes of St. George's Respiratory Questionnaire (SGRQ) score

  Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

• Changes of COPD Assessment Test (CAT) score

  Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

• COPD exacerbations

  Baseline and monthly thereafter through the 12th month

Other Outcomes (27)

• Change of Total Lung Volume (TLV)

  Baseline and after the completion of the intervention period (12 months anticipated)

• Change of mean pulmonary nodule size

  Baseline and after the completion of the intervention period (12 months anticipated)

• Change of mean airway wall thickness (WT)

  Baseline and after the completion of the intervention period (12 months anticipated)

Study Arms (2)

Active air purifier group

EXPERIMENTAL

Participants in this group received a home-based air purifier equipped with high-efficiency particulate air (HEPA) and carbon filters.

Behavioral: Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters

Sham air purifier group

SHAM COMPARATOR

Participants in this group received an air purifier identical in appearance to those used by the active air purifier group, but without the filtration function.

Behavioral: Using air purifiers with non-functional filtration system

Interventions

Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters BEHAVIORAL

Participants in the intervention arm will receive active air purifiers, which will be installed in their bedroom and the room where they spend the most time at home. The devices will operate continuously for the entire intervention period.

Active air purifier group

Using air purifiers with non-functional filtration system BEHAVIORAL

Participants in the intervention arm will receive sham air purifiers, which will be installed in their bedroom and the room where they spend the most time at home. The devices will operate continuously for the entire intervention period.

Sham air purifier group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 and 80 years old
• Physician diagnosis of COPD
• Living in Shanghai during the intervention period
• Subjects who have no plans to change homes during the intervention period
• Non-smokers and former smokers

You may not qualify if:

• Subjects living in a location other than home
• Subjects with a history of alcohol abuse
• Subjects with other chronic lung diseases, such as active tuberculosis, pulmonary fibrosis, cystic fibrosis, or alpha-1 antitrypsin deficiency
• Subjects with a history of thoracic surgery
• Subjects with a history of malignant tumors, such as lung cancer, liver cancer, or gastric cancer
• Subjects with diagnosed chronic hepatic or renal insufficiency, such as liver cirrhosis, chronic viral hepatitis, or autoimmune liver disease
• Subjects with acute myocardial infarction or unstable arrhythmia diagnosed within the past 6 weeks
• Subjects currently participating in other interventional studies

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

School of Public Health, Fudan University

Shanghai, China

RECRUITING

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

Central Study Contacts

Haidong Kan, Ph.D

CONTACT

+86-021-54237908; kanh@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 1, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

CN (1)