Clinical trial NCT03658538: Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
Official title: Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD, Chronic Obstructive Pulmonary Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2018-09-05
Enrollment: 144
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline and 6 months
measure: Change in Dyspnea as assessed by the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in COPD health status
timeFrame: Baseline and 6 months
measure: Change in Dyspnea as assessed by modified medical research Council questionnaire(mMRC)
timeFrame: Change from baseline and 6 months post-randomization
measure: Change in aggregate Health Care Utilization (number of episodes reported due to COPD-related exacerbation)
timeFrame: Baseline, 3 month and 6 months post-randomization
measure: Lung Function as assessed by Forced Expiratory Volume in 1 second (FEV1%)
timeFrame: Baseline and 6 months
measure: The Clinical COPD Questionnaire (CCQ)
timeFrame: Baseline and 6 months
Other outcomes:
measure: Change in Systemic markers of inflammation in serum (Interleukin-8)
timeFrame: Baseline and 6 months
measure: Change in Systemic markers of inflammation in serum (C-reactive protein)
timeFrame: Baseline and 6 months
measure: Change in Markers of oxidative stress in urine (8-isoprostane)
timeFrame: Baseline and 6 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Nadia N Hansel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: