COPD, Chronic Obstructive Pulmonary DiseaseMOVE-COPDNCT03658538
Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
A study testing Active HEPA Air Cleaner and Motivational interviewing in people with COPD, Chronic Obstructive Pulmonary Disease, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Active HEPA Air Cleaner and Motivational interviewing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to 7 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Campus
Baltimore, Maryland, 21224
About this study
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.
Read the detailed description
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.
- Being tested
- Active HEPA Air Cleaner, Motivational interviewing, Sham Air Cleaner
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active HEPA Air CleanerDevice
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 interviewingBehavioural
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 CleanerDevice
The Control arm will receive sham air cleaners
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Sham Air Cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline and 6 months
Secondary outcomes (5)
Change in COPD Health Status Will be Assessed by the COPD Assessment Test (CAT)
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.
Measured: Baseline and 6 months
Change in Dyspnea (Breathlessness) as Assessed by the Modified Medical Research Council Questionnaire (mMRC)
Dyspnea (breathlessness) assessed by the modified Medical Research Council questionnaire (mMRC). Mean Score range is 0-4. Higher scores indicate worse COPD control.
Measured: Change from baseline and 6 months post-randomization
Difference in the Proportion (Probability) of Health Care Utilization Due to COPD-related Exacerbations
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.
Measured: From Baseline to 6 months
Lung Function as Assessed by the Post Forced Expiratory Volume in 1 Second (FEV1%) Predicted
Pulmonary function testing will be assessed as FEV1% predicted, that is FEV1, adjusted for age, height, race and sex
Measured: Baseline and 6 months
Change in the Clinical COPD Questionnaire (CCQ)
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start3 Jun 2019
- Primary completion15 Aug 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPD, Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Nadia N Hansel, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658538
- Sponsor's protocol ID
- IRB00185955
- Other IDs
- R01ES029512
- Acronym
- MOVE-COPD
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2018
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
- ClinicalTrials.gov ID
- NCT03658538
- Acronym / sponsor ID
- MOVE-COPD / IRB00185955
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: Active HEPA Air Cleaner, Behavioral: Motivational interviewingThe 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). |
| Control Arm | Sham comparator | Device: Sham Air CleanerHomes 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active HEPA Air CleanerThe active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction. | Device | Active Treatment |
| Motivational interviewingThe 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. | Behavioural | Active Treatment |
| Sham Air CleanerThe Control arm will receive sham air cleaners | Device | Control Arm |
Primary outcome
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.
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).
5 secondary outcomes
Change in COPD Health Status Will be Assessed by the COPD Assessment Test (CAT)
Time frame: Baseline and 6 months
Change in Dyspnea (Breathlessness) as Assessed by the Modified Medical Research Council Questionnaire (mMRC)
Time frame: Change from baseline and 6 months post-randomization
Difference in the Proportion (Probability) of Health Care Utilization Due to COPD-related Exacerbations
Time frame: From Baseline to 6 months
Lung Function as Assessed by the Post Forced Expiratory Volume in 1 Second (FEV1%) Predicted
Time frame: Baseline and 6 months
Change in the Clinical COPD Questionnaire (CCQ)
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia N Hansel, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active HEPA Air Cleaner and Motivational interviewing in people with COPD, Chronic Obstructive Pulmonary Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life -St. George's Respiratory Questionnaire (SGRQ) (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.