Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)

NCT03658538 | Completed Results DMC FDA Device

• 2 other identifiers: IRB00185955R01ES029512
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

COPD is characterized by lung injury and inflammation caused by noxious particles and gases, including those emanating from cigarette smoke and air pollution. Despite the clear detrimental impact of poor air quality on respiratory outcomes, regardless of smoking status, to investigators' knowledge, there are no studied environmental interventions targeting indoor air quality to improve respiratory health of smokers, thus ignoring a potential target for harm reduction. Investigators propose a randomized controlled intervention trial to test whether targeted reductions of multiple indoor pollutants (PM, SHS and NO2) in homes of smokers with COPD will improve respiratory outcomes. Investigators have chosen a potent, multimodal intervention (active air cleaners + Motivational intervention for SHS reduction) in order to maximize the opportunity to prove that there is a health benefit to active smokers with COPD from indoor air pollution reduction.

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Life -St. George's Respiratory Questionnaire (SGRQ)

  St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more quality of life limitations.

  Baseline and 6 months

• Change in Dyspnea as Assessed by the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ)

  Dyspnea will be assessed using the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ). The SDSOBQ scoring will range from 0 to 120 (with higher scores indicating greater difficulty breathing).

  Baseline and 6 months

Secondary Outcomes (5)

• Change in COPD Health Status Will be Assessed by the COPD Assessment Test (CAT)

  Baseline and 6 months

• Change in Dyspnea (Breathlessness) as Assessed by the Modified Medical Research Council Questionnaire (mMRC)

  Change from baseline and 6 months post-randomization

• Difference in the Proportion (Probability) of Health Care Utilization Due to COPD-related Exacerbations

  From Baseline to 6 months

• Lung Function as Assessed by the Post Forced Expiratory Volume in 1 Second (FEV1%) Predicted

  Baseline and 6 months

• Change in the Clinical COPD Questionnaire (CCQ)

  Baseline and 6 months

Other Outcomes (3)

• Change in Systemic Markers of Inflammation in Serum (Interleukin-8)

  Baseline and 6 months

• Change in Systemic Markers of Inflammation in Serum (C-reactive Protein)

  Baseline and 6 months

• Change in Markers of Oxidative Stress in Urine (8-isoprostane)

  Baseline and 6 months

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).

Device: Active HEPA Air Cleaner; Behavioral: Motivational interviewing

Control Arm

SHAM COMPARATOR

Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.

Device: Sham Air Cleaner

Interventions

Active HEPA Air Cleaner DEVICE

The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.

Active Treatment

Motivational interviewing BEHAVIORAL

The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants). The Control arm will receive only continued counseling for smoking cessation.

Active Treatment

Sham Air Cleaner DEVICE

The Control arm will receive sham air cleaners

Control Arm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 40 years,
• Physician diagnosis of COPD,
• Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) \<70% and FEV1 (% predicted) \<80%. IF FEV1/FVC \<70% and FEV1 (% predicted) ≥ 80%, additional requirement will apply/will be asked: COPD Assessment Test (CAT) score ≥ 10 OR exacerbation history during the last 12 months.
• Tobacco exposure ≥ 10 pack-years
• Current smoker with an exhaled Carbon Monoxide (eCO) ≥ 7 ppm to confirm smoking status. We will employ a combination of self-report and a biochemical marker to identify former-smokers. (If no eCO performed due to COronaVIrus Disease-19 (COVID-19) pandemic safety reasons, we will rely on self-report smoking status and self-report 7-day abstinence questionnaire answers)
• No home smoking ban. IF smoking is not allowed indoor (inside participant's home) then a "home air quality assessment visit" may be done.

You may not qualify if:

• Chronic systemic corticosteroids,
• Other chronic lung disease including asthma,
• Living in location other than home (e.g., long term care facility)
• Home owner or occupant planning to move or change residence within study period.
• Air Cleaners drop off (home visits temporary criteria due to COVID-19).

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Nadia Hansel
• Organization: Johns Hopkins University

nhansel1@jhmi.edu

410-955-3841

Study Officials

• Nadia N Hansel, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 5, 2018
• Study Start: June 3, 2019
• Primary Completion: August 15, 2024
• Study Completion: November 7, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)