Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 9/7/2018 |
| Start Date: | February 2019 |
| End Date: | December 2024 |
| Contact: | Karina Romero, MD |
| Email: | kromero4@jhmi.edu |
| Phone: | 4105502602 |
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.
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. All participants will continue to receive smoking cessation counseling
throughout the study period, including those that quit smoking during the run in period.
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.
(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. All participants will continue to receive smoking cessation counseling
throughout the study period, including those that quit smoking during the run in period.
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.
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%,
- Tobacco exposure ≥ 10 pack-years
- Current smoker with an exhaled Carbon Monoxide (eCO)> 10 ppm to confirm smoking status
- No home smoking ban.
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.
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: Nadia N Hansel, MD
Phone: 410-550-2602
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