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

Study Overview

• Status: Recruiting
• Conditions: COPD, Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Active HEPA Air Cleaner; Behavioral: Motivational interviewing; Device: Sham Air Cleaner

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy Lorizio, MD, MPH; Phone Number: 4105502449; Email: wlorizi1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Campus
      • Contact: Maggie Maly; Phone Number: 410-550-9527; Email: mmaly1@jhmi.edu
      • Principal Investigator: Nadia N Hansel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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: 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 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Device: 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.; Behavioral: 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.
Sham Comparator: 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.	Device: Sham Air Cleaner; The Control arm will receive sham air cleaners

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in COPD health status	COPD health status will be assessed with 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 Quality of Life	St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dyspnea as assessed by modified medical research Council questionnaire(mMRC)	Dyspnea will be assessed using the modified medical research Council questionnaire(mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).is from 0 to 40. Higher scores indicate worse COPD control	Change from baseline and 6 months post-randomization
Change in aggregate Health Care Utilization (number of episodes reported due to COPD-related exacerbation)	We will administer a questionnaire 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. Report of HCU due to COPD-related exacerbation will be collected at baseline, at 3 and at 6 month clinic visits. The aggregate HCU number could range from 0 (zero/none event reported) to 1 or more episodes reported during the last 3 months.	Baseline, 3 month and 6 months post-randomization
Lung Function as assessed by Forced Expiratory Volume in 1 second (FEV1%)	Pulmonary function testing will be assessed as FEV1% predicted, that is FEV1, adjusted for age, height, race and sex	Baseline and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systemic markers of inflammation in serum (Interleukin-1 beta)	Interleukin-1 beta concentration in serum (units/mg)	Baseline and 6 months
Change in Systemic markers of inflammation in serum (C-reactive protein)	C-reactive protein concentration in serum will be expressed in: mg/l	Baseline and 6 months
Change in Markers of oxidative stress in urine (8-isoprostane)	8-isoprostane concentration in urine (pg/ml)	Baseline and 6 months
Change in Markers of inflammation in induced sputum (neutrophils count differential)	The induced sputum supernatant will be stored and frozen for comparison on cell count differential (neutrophils)	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Nadia N Hansel, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: IRB00185955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes