NCT07344987

Brief Summary

Air pollution threatens the respiratory health of patients with interstitial lung disease (ILD). High-efficiency air purifiers, featuring easy operation and excellent particulate matter removal efficiency, have been shown in previous studies to potentially delay lung function deterioration and reduce acute exacerbation risk in respiratory disease patients. This randomized crossover study employs air purifiers to filter indoor gaseous pollutants, allergens, and other contaminants, aiming to alleviate respiratory irritation, improve daily life comfort, and enhance overall health status in ILD patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

December 22, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 22, 2025

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Symptom Improvement-related Indicators (e.g., Improvement in Respiratory Symptom Score)

    St. George's Respiratory Questionnaire (SGRQ):Score Range:Minimum score: 0 points;Maximum score: 100 points.A higher score indicates worse outcomes for the patient.

    Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)

  • Pulmonary Function Indicators (e.g., Pulmonary Diffusing Capacity)

    Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)

  • Quality of Life Indicators (e.g., CAT Score)

    COPD Assessment Test (CAT):It is a short, validated, patient-reported outcome (PRO) tool specifically designed to measure the impact of pulmonary disease on a patient's health status and daily life.Score Range:Minimum score: 0 points;Maximum score: 40 points.A higher score indicates worse health status and greater pulmonary disease-related burden for the patient.

    Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)

  • Blood Sample Indicators (e.g., Concentration of Interleukin-8)

    Assessment of Changes in Pulmonary Inflammation or Lung Injury Before and After Intervention Using Concentrations of Biomarkers Such as Interleukin-8

    Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)

Study Arms (2)

Purifier (without Filter) Arm

SHAM COMPARATOR
Behavioral: Purifier (without Filter) Arm

Air Purifier (with Filter) Arm

EXPERIMENTAL
Behavioral: Air Purifier (with Filter) Arm

Interventions

Place an air purifier with high-efficiency filters in the home, and turn it on for at least 18 hours every day.

Air Purifier (with Filter) Arm

Place an air purifier without a filter in the home.

Purifier (without Filter) Arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with interstitial lung disease (ILD).
  • Stable disease status, defined as no hospitalization due to acute exacerbation within the past month.

You may not qualify if:

  • Patients with complications of severe organ failure (including heart, liver, or kidney failure), malignant tumors, or mental disorders.
  • A history of respiratory tract infection within the past two weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Air Filters

Intervention Hierarchy (Ancestors)

FiltrationChemistry Techniques, AnalyticalInvestigative TechniquesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 15, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

1. The informed consent form signed by study participants does not include clauses authorizing the sharing of de-identified individual participant data (IPD) with external researchers. In accordance with the ethical approval requirements, no secondary use of IPD beyond the primary study objectives is permitted without explicit participant consent. 2. The sample size of this study is relatively small, and the collected IPD has high heterogeneity due to individual differences in patient clinical characteristics and intervention responsiveness. Sharing such a limited dataset may not support robust secondary research findings, and could lead to misleading interpretations of the intervention effect on pulmonary inflammation.