- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344987
Effect of Indoor Air Quality Improvement on Health in Patients With Interstitial Lung Disease
January 7, 2026 updated by: Hongbing Xu, Peking Union Medical College
A Randomized Crossover Trial of Indoor Air Quality Improvement on Health in Patients With Interstitial Lung Disease
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients diagnosed with interstitial lung disease (ILD).
- Stable disease status, defined as no hospitalization due to acute exacerbation within the past month.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Purifier (without Filter) Arm
|
Place an air purifier without a filter in the home.
|
|
Experimental: Air Purifier (with Filter) Arm
|
Place an air purifier with high-efficiency filters in the home, and turn it on for at least 18 hours every day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Improvement-related Indicators (e.g., Improvement in Respiratory Symptom Score)
Time Frame: Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
|
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)
Time Frame: Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
|
Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
|
|
|
Quality of Life Indicators (e.g., CAT Score)
Time Frame: Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
|
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)
Time Frame: Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
December 22, 2025
First Submitted That Met QC Criteria
January 7, 2026
First Posted (Actual)
January 15, 2026
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMS-PUMC-IRM-IAQ-ILD-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
- 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.
- 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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