Chronic Obstructive Pulmonary DiseaseNCT02775487
Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients.
An observational study of Chronic Obstructive Pulmonary Disease, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Primary objective of this project is to measure the impact of passive control and active control systems on indoor pollution that is directly or indirectly related to ambient air pollution (smog). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from pulmonary rehabilitation centers in St. Louis, MO. Potential participants will be screened to ascertain eligibility based on diagnosis and stage of disease progression.
Who may be able to join
- diagnosis of COPD (stage III or IV); adults over the age of 18 years
Who cannot join
- Children (persons under age 18), fetuses, neonates, pregnant women, prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients: Effectiveness of Controls
Primary objective of this project is to measure the impact of passive control and active control systems on indoor pollution that is directly or indirectly related to ambient air pollution (smog). The first goal will be to measure baseline parameters for 50 homes, including information about the building, ventilation characteristics, pollution levels (indoors and outdoors), and occupant survey information. In a subset of these homes, either passive or active control systems will be installed and the impact of these systems on indoor concentrations. Participants will be enrolled on a rolling basis (5-15 persons studied at a given point in time) over a 16-month period. Participants will be followed for approximately 5 weeks and data obtained at three points in time: at enrollment (day 1 of study), after 1 week (baseline verification) and after four weeks with the control system in the home (at the end of study week 5).
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a degenerative lung disease resulting in lower lung function characterized by an obstruction to airflow. COPD is an umbrella term for two disease processes: chronic bronchitis and emphysema. It is currently the 4th leading cause of death in the United States. Approximately 14 million Americans are known to suffer from COPD; however, it is estimated that as many as 24 million Americans may have some form of one or both of the diseases (Centers for Disease Control, 2011). The primary risk factor for developing COPD is cigarette smoking; other factors include exposure to air pollution, occupational dusts and chemicals, and lower socioeconomic status. Poverty has been identified as a risk factor for COPD but the aspects related to poverty that increase the risk of COPD are unclear (GOLD, 2011). Lower education level and household income has been noted to relate to increased severity of COPD (Eisner, Blanc, Omachi, Yelin, Sidney, Katz, et al, 2011). An American Lung Association survey found that over half of those diagnosed with COPD reported that their condition limits their ability to perform activities of daily living, including activities in the home (American Lung Association, 2009). As air pollution can lead to an exacerbation of COPD symptoms and precipitate emergency room visits and hospitalization, minimizing pollution in indoor air may be a key component of disease management and decreasing health care costs.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Air quality
- 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD and air quality | Persons enrolled in the study will have been diagnosed with Stage III or IV COPD and samples of air taken from their home environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Air quality measures at week 5
Air samples taken from the home
Measured: week 5 of study
Secondary outcomes (3)
Change in Borg scale for breathlessness from week 1 to week 5
Scale on which participant rates perceived breathlessness
Measured: week 1 of study, week 2 of study and week 5 of study
Change in vital signs from week 1 to week 5
Heart rate, respiratory rate, blood pressure, oxygen saturation (SpO2) via pulse oximetry, bedside spirometry
Measured: week 1 of study, week 2 of study and week 5 of study
Change in Air quality measures from week 1 to week 5
Change in Air quality measures from week 1 to week 5
Measured: week 1 and week 2 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2013 (estimated)
- Study completionJan 2013
Why it stopped: Withdrawn before IRB review. Investigator no longer working at facility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Shawna L Strickland, PhD, RRT, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775487
- Sponsor's protocol ID
- ST-MU-UT 2012
- Status last verified
- Sep 2016
- First submitted
- 23 Jan 2012
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients: Effectiveness of Controls
- ClinicalTrials.gov ID
- NCT02775487
- Acronym / sponsor ID
- ST-MU-UT 2012
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Air quality
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawn before IRB review. Investigator no longer working at facility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- Jan 2013
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective of this project is to measure the impact of passive control and active control systems on indoor pollution that is directly or indirectly related to ambient air pollution (smog). The first goal will be to measure baseline parameters for 50 homes, including information about the building, ventilation characteristics, pollution levels (indoors and outdoors), and occupant survey information. In a subset of these homes, either passive or active control systems will be installed and the impact of these systems on indoor concentrations. Participants will be enrolled on a rolling basis (5-15 persons studied at a given point in time) over a 16-month period. Participants will be followed for approximately 5 weeks and data obtained at three points in time: at enrollment (day 1 of study), after 1 week (baseline verification) and after four weeks with the control system in the home (at the end of study week 5).
Detailed description
Chronic obstructive pulmonary disease (COPD) is a degenerative lung disease resulting in lower lung function characterized by an obstruction to airflow. COPD is an umbrella term for two disease processes: chronic bronchitis and emphysema. It is currently the 4th leading cause of death in the United States. Approximately 14 million Americans are known to suffer from COPD; however, it is estimated that as many as 24 million Americans may have some form of one or both of the diseases (Centers for Disease Control, 2011). The primary risk factor for developing COPD is cigarette smoking; other factors include exposure to air pollution, occupational dusts and chemicals, and lower socioeconomic status. Poverty has been identified as a risk factor for COPD but the aspects related to poverty that increase the risk of COPD are unclear (GOLD, 2011). Lower education level and household income has been noted to relate to increased severity of COPD (Eisner, Blanc, Omachi, Yelin, Sidney, Katz, et al, 2011). An American Lung Association survey found that over half of those diagnosed with COPD reported that their condition limits their ability to perform activities of daily living, including activities in the home (American Lung Association, 2009). As air pollution can lead to an exacerbation of COPD symptoms and precipitate emergency room visits and hospitalization, minimizing pollution in indoor air may be a key component of disease management and decreasing health care costs.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD and air quality | – | –Persons enrolled in the study will have been diagnosed with Stage III or IV COPD and samples of air taken from their home environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from pulmonary rehabilitation centers in St. Louis, MO. Potential participants will be screened to ascertain eligibility based on diagnosis and stage of disease progression.
Key inclusion criteria (1 listed)
- diagnosis of COPD (stage III or IV); adults over the age of 18 years
Key exclusion criteria (1 listed)
- Children (persons under age 18), fetuses, neonates, pregnant women, prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Air quality measures at week 5
Time frame: week 5 of study
Air samples taken from the home
3 secondary outcomes
Change in Borg scale for breathlessness from week 1 to week 5
Time frame: week 1 of study, week 2 of study and week 5 of study
Change in vital signs from week 1 to week 5
Time frame: week 1 of study, week 2 of study and week 5 of study
Change in Air quality measures from week 1 to week 5
Time frame: week 1 and week 2 of the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- 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.
Shawna L Strickland, PhD, RRT principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University of Missouri-Columbia 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 30 Sep 2016. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Air quality measures at week 5 (time frame: week 5 of study). 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 30 Sep 2016.