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Completed

NCT Number: NCT03658538

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

About this study

People with COPD who have higher exposure to indoor pollutants, including particulate matter (PM), second hand smoke (SHS), and nitrogen dioxide (NO2) have worse respiratory morbidity including a higher risk of exacerbations. These effects are not obscured by smoking habit. Unfortunately, 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 in order to maximize the opportunity to prove that there is a health benefit to active smokers with COPD from indoor air pollution reduction. After a one-month run in period in which all participants will receive smoking cessation strategies including Motivational Interviewing (MI) and nicotine replacement therapy, participants unable to quit smoking (n=120) will have 1:1 randomization to receive either 1) multi-component environmental intervention (active "high-efficiency particulate air"(HEPA) air cleaners + MI intervention for SHS reduction) or 2) sham air cleaners. Referrals to community resources for additional support will also be provided. Investigators aim to determine whether a multi-component environmental intervention (targeting PM, SHS and NO2 reduction) will improve respiratory morbidity (i.e., symptoms, quality of life, lung function and exacerbation risk) (Specific Aim #1) and intermediate outcome measures (i.e., markers of airway and systemic inflammation and oxidative stress) (Specific Aim #2) in smokers with COPD. Investigators anticipate that results from this study will inform clinical practice guidelines and health care policies aimed at reducing COPD morbidity and may have broader implications for indoor environmental recommendations for smokers with chronic disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Sham air cleaner

Device

The Control arm will receive sham air cleaners

Primary outcomes

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

    Time frame: Baseline and 6 months

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

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

    Time frame: Baseline and 6 months

    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).

Secondary outcomes

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

    Time frame: Baseline and 6 months

    Change in COPD health status will be assessed by the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control.

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

    Time frame: Change from baseline and 6 months post-randomization

    Dyspnea (breathlessness) assessed by the modified Medical Research Council questionnaire (mMRC). Mean Score range is 0-4. Higher scores indicate worse COPD control.

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

    Time frame: From Baseline to 6 months

    Questionnaire administered to collect participant's self report of Health Care Utilization (HCU) episodes due to COPD-related exacerbation (including need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization). This questionnaire will be administered at baseline and during the 6 months of follow-up. The HCU number could range from 0 (zero/no episode reported) to 1 (1 or more episodes reported) during the 6 months follow-up.

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

    Time frame: Baseline and 6 months

    Pulmonary function testing will be assessed as FEV1% predicted, that is FEV1, adjusted for age, height, race and sex

  5. Change in the Clinical COPD Questionnaire (CCQ)

    Time frame: Baseline and 6 months

    The Clinical COPD Questionnaire (CCQ) will be administered to evaluate health status in patients with COPD. The CCQ is a 10-item questionnaire, health-related quality of life questionnaire (HRQoL) with good psychometric properties. The total score ranges from 0 to 6, where a higher scores indicates a worse health status.

Other outcomes

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

    Time frame: Baseline and 6 months

    Change in systemic markers of inflammation in serum (Interleukin-8) will be measured by Interleukin-8 concentration in serum (units/mg).

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

    Time frame: Baseline and 6 months

    Change in Systemic markers of inflammation in serum (C-reactive protein) will be measured by C-reactive protein concentration in serum and it will be expressed in: mg/l

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

    Time frame: Baseline and 6 months

    Change in Markers of oxidative stress in urine (8-isoprostane) will be measured by 8-isoprostane concentration in urine (pg/ml).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Acronym: MOVE-COPD

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2018
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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