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| ID | Type | Description | Link |
|---|---|---|---|
| R01ES029512 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Change in Dyspnea (Breathlessness) as Assessed by the Modified Medical Research Council Questionnaire (mMRC) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systemic Markers of Inflammation in Serum (Interleukin-8) | Change in systemic markers of inflammation in serum (Interleukin-8) will be measured by Interleukin-8 concentration in serum (units/mg). | Baseline and 6 months |
| Change in Systemic Markers of Inflammation in Serum (C-reactive Protein) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadia N Hansel, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Campus | Baltimore | Maryland | 21224 | United States |
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Of the 144 enrolled participants, 121 met inclusion criteria. 1 of those participants dropped out prior to completing the baseline visit and was excluded from analysis.
Participants were recruited in the Baltimore/Washington are (MD, USA) between June 2019 and January 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | The active treatment arm will receive two portable active High-Efficiency Particulate Air (HEPA) air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and secondhand smoking (SHS) reduction in addition to the smoking cessation counseling received by all study participants. Active HEPA (high-efficiency particulate air) Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA (high-efficiency particulate air) and carbon filters to support a home smoking ban and SHS (secondhand smoking) reduction. Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS (secondhand smoking) reduction (in addition to the smoking cessation counseling received by all study participants). The Control arm will receive only continued counseling for smoking cessation. |
| FG001 | Control Arm | Homes in the control group will receive Sham air cleaners that have the internal high-efficiency particulate air (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 secondhand smoking (SHS) reduction, they will receive only smoking cessation counseling. Sham Air Cleaner: The Control arm will receive sham air cleaners |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | 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). Active HEPA Air Cleaner: 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: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The difference in the overall number of participants analyzed is due to participants not having SGRQ data collected in either baseline and/or 6 months period. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 6 months |
|
From randomization up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | 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). Active HEPA Air Cleaner: 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: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension (Elevated high blood pressure) | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nadia Hansel | Johns Hopkins University | 410-955-3841 | nhansel1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2022 | Aug 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2025 | Aug 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| 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. |
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| Sham Air Cleaner | Device | The Control arm will receive sham air cleaners |
|
Dyspnea (breathlessness) assessed by the modified Medical Research Council questionnaire (mMRC). Mean Score range is 0-4. Higher scores indicate worse COPD control. |
| 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. | 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 | 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. | 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 |
| Baseline and 6 months |
| Change in Markers of Oxidative Stress in Urine (8-isoprostane) | Change in Markers of oxidative stress in urine (8-isoprostane) will be measured by 8-isoprostane concentration in urine (pg/ml). | Baseline and 6 months |
| Change residence |
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| Lost to Follow-up |
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| Unblinded |
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| Physician Decision |
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| Incomplete clinical visit at 6 months due to illness |
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| Evicted from home |
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| BG001 | Control Arm | 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. Sham Air Cleaner: The Control arm will receive sham air cleaners |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Some College Education or Above | Count of Participants | Participants |
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| OG001 | Control Arm | 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. Sham Air Cleaner: The Control arm will receive sham air cleaners |
|
|
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| Primary | 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). | The difference in the overall number of participants analyzed is due to participants not having the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ) data collected n either baseline and/or 6 months period. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 6 months |
|
|
|
|
| Secondary | 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. | The difference in the overall number of participants analyzed is due to participants not having the COPD assessment test (CAT) data collected in either baseline and/or 6 months period. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 6 months |
|
|
|
| Secondary | 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. | The difference in the overall number of participants analyzed is due to participants not having the modified Medical Research Council questionnaire (mMRC) data collected in either baseline and/or 6 months period. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline and 6 months post-randomization |
|
|
|
| Secondary | 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. | The difference in the overall number of participants analyzed is due to participants not completing (data not collected) the exacerbation survey between baseline and 6 months | Posted | Mean | 95% Confidence Interval | Proportion of events | From Baseline to 6 months |
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| Secondary | 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 | The difference in the overall number of participants analyzed is due to participants not having FEV1 data collected in either baseline and/or 6 months period. | Posted | Mean | 95% Confidence Interval | FEV1 percent predicted | Baseline and 6 months |
|
|
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| Secondary | 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. | The difference in the overall number of participants analyzed is due to participants not having the Clinical COPD Questionnaire (CCQ) data collected in either baseline and/or 6 months period. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 6 months |
|
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| Other Pre-specified | Change in Systemic Markers of Inflammation in Serum (Interleukin-8) | Change in systemic markers of inflammation in serum (Interleukin-8) will be measured by Interleukin-8 concentration in serum (units/mg). | Not Posted | Baseline and 6 months | Participants |
| Other Pre-specified | Change in Systemic Markers of Inflammation in Serum (C-reactive Protein) | 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 | Not Posted | Baseline and 6 months | Participants |
| Other Pre-specified | Change in Markers of Oxidative Stress in Urine (8-isoprostane) | Change in Markers of oxidative stress in urine (8-isoprostane) will be measured by 8-isoprostane concentration in urine (pg/ml). | Not Posted | Baseline and 6 months | Participants |
| 2 |
| 59 |
| 4 |
| 59 |
| 3 |
| 59 |
| EG001 | Control Arm | 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. Sham Air Cleaner: The Control arm will receive sham air cleaners | 1 | 61 | 3 | 61 | 1 | 61 |
| Gastric Mass | Gastrointestinal disorders | Non-systematic Assessment |
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| Syncope (Hypotension and dehydration) | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Influenza (Hospitalized) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Knee Scope Surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Acute Kidney Injury (AKI) | Renal and urinary disorders | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Adverse Reaction (Palpitations/jitters) to the Nicotine Replacement Therapy (Gum) | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | Non-systematic Assessment |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |