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Chronic Obstructive Pulmonary Disease Patient Preferences Survey

COPD Patient Preferences, Activities, and Participation Survey

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02970422
Enrollment
200
Registered
2016-11-22
Start date
2016-11-30
Completion date
2018-12-12
Last updated
2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Survey, Priorities, Activities, Participation

Brief summary

The purpose of this study is to distribute a questionnaire created for individuals living with chronic obstructive pulmonary disease (COPD) to assess their activities, participation, and healthcare and COPD-related research priorities. The data collected will be compared across diagnosed COPD stages and disease severity to determine the extent to which adults with COPD participate in the listed activities and identify their primary research and healthcare related priorities. The questionnaire was originally developed based on past research then verified by a panel of COPD and participation experts; as well as, individuals living with COPD in the form of focus groups. The questionnaire will now be administered to 200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where clinical data for each participant will be available. This phase will help establish the reliability of the questionnaire.

Interventions

Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.

Sponsors

AstraZeneca
CollaboratorINDUSTRY
McGill University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of COPD * English or French speaking * Patient at one of the three participating sites with medical chart

Exclusion criteria

* No diagnosis of COPD by a healthcare professional * Unable to communicate in English or French * Unable to provide informed consent * No medical chart information at one of the three participating sites

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Prioritized Healthcare TopicsBaselineTwenty-four healthcare topics were selected once again from a literature and expert panel review, as well as corroborated by individuals living with COPD in five focus groups. Example healthcare topics include: relief of breathlessness; increase maximal amount of exercise individuals living with COPD can do inside and outside their homes; and prevent-lung flare-ups. Participants were asked to indicate their preference of the topics by assigning a percentage of their time, in increments of 10%, to the various healthcare topics, for a total of 100% of their time. For the 24 healthcare topics, individuals could select up to 10 topics (10% times 10 topics, for 100% of their time). The top five topics are presented as the most important topics for the participants and are indicative of areas of focus for future healthcare and research. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.
Number of Participants Who Prioritized Research TopicsBaselineIndividuals were asked to indicate their research priorities from a list of research topics using a modified willingness-to-pay method (Kawata et al., 2014). The willingness-to-pay method allows individuals to assign preference to various topics by assigning a percentage of funds to the topic. A list of 22 research topics (e.g., to relieve breathlessness in individuals living with COPD, to increase access to lung transplantations) was created for this study through a literature review, expert consultation, and five focus groups with individuals living with COPD (n=23, 27% women). Individuals were asked to assign a percentage of funds, in increments of 10% of funding, to the 22 COPD research topics. Participants could assign anywhere between 10% of funding to 100% of funding to the topics. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesBaselineParticipants will answer questions about their participation in 26 daily activities, as well as their desire to participate in each of the 26 daily activities. This is a measure of those who indicated they wanted to increase their participation. 10 of the 26 activities and their outcome measures are listed below. Activity 1: Walking from one place to another outside of your home on a flat surface. Activity 2: Moving from one place to another using motorized transportation. Activity 3: Climbing two or more flights of stairs. Activity 4: Walking up a hill. Activity 5: Participating in regular exercise. Activity 6: Walking from one place to another in your home. Activity 7: Carrying light objects on a flat surface. Activity 8: Carrying heavy objects on a flat surface. Activity 9: Carrying-out low intensity physical activities

Secondary

MeasureTime frameDescription
COPD Assessment TestBaselineThis questionnaire measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Items include: I never cough\| I cough all the time, I have no phlegm (mucus) in my chest at all \| My chest is completely full of phlegm (mucus), My chest does not feel tight at all \| My chest feels very tight, When I walk up a hill or one flight of stairs, I am not breathless \| When I walk up a hill or one flight of stairs, I am very breathless, I am not limited doing any activities at home\| I am very limited doing activities at home, I am confident leaving my home despite my lung condition\| I am not at all confident leaving my home because of my lung condition, I sleep soundly \| I don't sleep soundly because of my lung condition, I have lots of energy I have no energy at all. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.
Godin Leisure Time Physical Activity QuestionnaireBaselineSelf-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.
Forced Expiratory Volume in 1-sec (FEV1)BaselineIndividuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry
Number of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsbaselineAn exacerbation was defined as a change in medication due to a COPD exacerbation (i.e., the prescription of prednisone or a medical action plan) as indicated in the medical chart or hospital admission due to a COPD exacerbation.
Satisfaction of Life QuestionnaireBaselineThis 5 item questionnaire was used to measure participants' level of life satisfaction. The higher the score, the higher the sense of life satisfaction. A score from 5-9 indicated extremely dissatisfied, 10-14 is dissatisfied, 15-19 indicated slightly below average life satisfaction. 20-24 is the average score, 25-29 is a high score indicative of higher life satisfaction and a score between 30-35 is a very high score and represent very high life satisfaction.
FEV1/FVCBaselineIndividuals FEV1-to-forced vital capacity (FVC) ratio
Modified Medical Research Council Questionnaire on BreathlessnessBaselineSelf-reported intensity of activity related breathlessness as assessed by the modified Medical Research Council (mMRC) dyspnea scale (0-4). This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.

Countries

Canada

Participant flow

Recruitment details

200 participants completed the AHRPQ. Of those, 52 were missing spirometry in medical records, 148 completed with spirometry for Quartile 1-4 analysis \[groups\], and 130 of the 148 completed spirometry, exacerbation and mMRC for Group A-D analysis.

Participants by arm

ArmCount
All Participants
Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.
200
Total200

Baseline characteristics

CharacteristicAll Participants
Age, Continuous67.5 Years
STANDARD_DEVIATION 8.8
Asthma64 Participants
Cancer25 Participants
CAT (COPD assessment test)
score ≥10 (higher than normal burden of disease )
163 Participants
CAT (COPD assessment test)
score <10 (less than normal burden of disease)
34 Participants
Cerebrovascular disease3 Participants
Chronic kidney disease5 Participants
Congestive heart failure15 Participants
Connective tissue disease3 Participants
Dementia1 Participants
Diabetes Mellitus18 Participants
Education
Full-time/Part-time
86 Participants
Education
Unemployed/Retired/Disability
108 Participants
Hemiplegia0 Participants
HIV/AIDS1 Participants
Household Income
Above $60,000
43 Participants
Household Income
Under $60,000
118 Participants
Liver disease4 Participants
Marital Status
Married/Common Law
108 Participants
Marital Status
Single/Divorced/Widowed
86 Participants
mMRC (Modified-Medical Research Council Questionnaire on breathlessness)
0-1 (mild breathlessnes)
67 Participants
mMRC (Modified-Medical Research Council Questionnaire on breathlessness)
≥2 (increased breathlessness)
129 Participants
Myocardial Infarction11 Participants
Peripheral vascular disease7 Participants
Pulmonary Rehab Attendance
No
112 Participants
Pulmonary Rehab Attendance
Yes
81 Participants
Race/Ethnicity, Customized
Race
Other
12 Participants
Race/Ethnicity, Customized
Race
White
181 Participants
Region of Enrollment
Canada
200 Participants
Sex: Female, Male
Female
96 Participants
Sex: Female, Male
Male
103 Participants
Smoking
Ever smoked tobacco
184 Participants
Smoking
Never smoked tobacco
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Number of Participants Who Prioritized Healthcare Topics

Twenty-four healthcare topics were selected once again from a literature and expert panel review, as well as corroborated by individuals living with COPD in five focus groups. Example healthcare topics include: relief of breathlessness; increase maximal amount of exercise individuals living with COPD can do inside and outside their homes; and prevent-lung flare-ups. Participants were asked to indicate their preference of the topics by assigning a percentage of their time, in increments of 10%, to the various healthcare topics, for a total of 100% of their time. For the 24 healthcare topics, individuals could select up to 10 topics (10% times 10 topics, for 100% of their time). The top five topics are presented as the most important topics for the participants and are indicative of areas of focus for future healthcare and research. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.

Time frame: Baseline

Population: Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry \& exacerbation and mMRC for Group ABCD analysis.

ArmMeasureGroupValue (NUMBER)
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities79 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being70 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD71 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups74 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness90 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities67 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness79 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being62 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD61 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups64 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being20 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities20 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness23 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD18 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups18 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups18 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being15 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD19 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities22 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness22 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD23 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness21 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities15 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups18 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being17 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups20 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD11 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities22 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness24 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being18 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness11 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups14 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities12 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being12 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD12 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities30 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness36 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being26 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups23 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD27 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities6 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being9 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups7 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness5 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD6 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsDiscuss COPD16 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsRelief of Breathlessness27 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsPrevent Lung Flare-Ups20 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsImprove Your Ability to Improve Activities19 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Healthcare TopicsImprove Physical Well-Being15 participants
Comparison: Improve your ability to perform activities in and out of your homep-value: 0.31Chi-squared
Comparison: Prevent lung flare-upsp-value: 0.96Chi-squared
Comparison: Discuss COPD and its progressionp-value: 0.04Chi-squared
Comparison: Improve your physical well-beingp-value: 0.7Chi-squared
Comparison: Relief of breathlessnessp-value: 0.91Chi-squared
Comparison: Relief of breathlessnessp-value: 0.01Chi-squared
Comparison: Improve your ability to perform activities in and out of your homep-value: 0.49Chi-squared
Comparison: Prevent lung flare-upsp-value: 0.93Chi-squared
Comparison: Discuss COPD and its progressionp-value: 0.6Chi-squared
Comparison: Improve your physical well-beingp-value: 0.31Chi-squared
Primary

Number of Participants Who Prioritized Research Topics

Individuals were asked to indicate their research priorities from a list of research topics using a modified willingness-to-pay method (Kawata et al., 2014). The willingness-to-pay method allows individuals to assign preference to various topics by assigning a percentage of funds to the topic. A list of 22 research topics (e.g., to relieve breathlessness in individuals living with COPD, to increase access to lung transplantations) was created for this study through a literature review, expert consultation, and five focus groups with individuals living with COPD (n=23, 27% women). Individuals were asked to assign a percentage of funds, in increments of 10% of funding, to the 22 COPD research topics. Participants could assign anywhere between 10% of funding to 100% of funding to the topics. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.

Time frame: Baseline

Population: Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry \& exacerbation and mMRC for Group ABCD analysis.

ArmMeasureGroupValue (NUMBER)
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups74 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise68 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD113 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD85 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise70 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD98 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups62 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise61 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise57 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD74 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise20 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD28 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD18 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups18 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise21 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise12 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups18 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD29 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD26 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise14 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise17 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise15 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD26 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD22 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups14 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise20 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups24 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise19 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD30 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD19 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise6 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise11 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD20 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD15 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups14 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise29 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD30 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups24 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise29 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD40 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise7 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD7 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise4 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups3 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD9 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo relieve breathlessness in COPD31 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo prevent lung flare ups21 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo improve maximal amount of exercise18 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo increase the ability to exercise14 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Prioritized Research TopicsTo prevent the development of COPD20 participants
Comparison: To relieve breathlessness in adults living with COPDp-value: 0.73Chi-squared
Comparison: To prevent the development of COPDp-value: 0.23Chi-squared
Comparison: To prevent lung flare-ups in adults living with COPDp-value: 0.14Chi-squared
Comparison: To increase the ability of adults living with COPD to exercisep-value: 0.52Chi-squared
Comparison: To improve the maximal amount of exercise of adults living with COPD in and out of the homep-value: 0.11Chi-squared
Comparison: To relieve breathlessness in adults living with COPDp-value: 0.14Chi-squared
Comparison: To prevent the development of COPDp-value: 0.73Chi-squared
Comparison: To prevent lung flare-ups in adults living with COPDp-value: 0.2Chi-squared
Comparison: To increase the ability of adults living with COPD to exercisep-value: 0.17Chi-squared
Comparison: To improve the maximal amount of exercise of adults living with COPD in and out of the homep-value: 0.02Chi-squared
Primary

Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities

Participants will answer questions about their participation in 26 daily activities, as well as their desire to participate in each of the 26 daily activities. This is a measure of those who indicated they wanted to increase their participation. 10 of the 26 activities and their outcome measures are listed below. Activity 1: Walking from one place to another outside of your home on a flat surface. Activity 2: Moving from one place to another using motorized transportation. Activity 3: Climbing two or more flights of stairs. Activity 4: Walking up a hill. Activity 5: Participating in regular exercise. Activity 6: Walking from one place to another in your home. Activity 7: Carrying light objects on a flat surface. Activity 8: Carrying heavy objects on a flat surface. Activity 9: Carrying-out low intensity physical activities

Time frame: Baseline

Population: Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry \& exacerbation and mMRC for Group ABCD analysis.

ArmMeasureGroupValue (NUMBER)
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 63 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 4142 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1108 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 3114 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 930 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 899 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 5117 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 217 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1090 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 719 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 183 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 3101 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1071 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 225 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 928 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 4107 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 60 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 715 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 886 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 587 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 105 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 811 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 25 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 424 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 75 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 95 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 522 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 324 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 60 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 18 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 327 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 441 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 60 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 23 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 522 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1017 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 73 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 822 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 127 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 93 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 828 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1030 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 73 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 130 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 322 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 93 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 23 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 532 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 439 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 63 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 143 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 26 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 438 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 60 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 838 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 341 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 541 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 78 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 919 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1038 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 312 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 58 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 60 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 18 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 98 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 87 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 215 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 100 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 74 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 419 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 76 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 444 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 544 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 60 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1024 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 330 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 827 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 22 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 98 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 138 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 20 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 40 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 97 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 70 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 321 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 57 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 814 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1014 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 17 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 60 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 95 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 444 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 838 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 28 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 75 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 60 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 130 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 528 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 1033 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants Who Were Not Satisfied With Their Participation in Daily and Social ActivitiesActivity 338 participants
Comparison: Activity 1: Walking from one place to another outside of your home on a flat surfacep-value: 0.05Chi-squared
Comparison: Activity 2: Moving from one place to another using motorized transportationp-value: 0.87Chi-squared
Comparison: Activity 3: Climbing two or more flights of stairsp-value: 0.65Chi-squared
Comparison: Activity 4: Walking up a hillp-value: 0.35Chi-squared
Comparison: Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitnessp-value: 0.03Chi-squared
Comparison: Activity 1: Walking from one place to another outside of your home on a flat surfacep-value: 0Chi-squared
Comparison: Activity 2: Moving from one place to another using motorized transportationp-value: 0.33Chi-squared
Comparison: Activity 3: Climbing two or more flights of stairsp-value: 0Chi-squared
Comparison: Activity 4: Walking up a hillp-value: 0.01Chi-squared
Comparison: Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitnessp-value: 0.02Chi-squared
Secondary

COPD Assessment Test

This questionnaire measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Items include: I never cough\| I cough all the time, I have no phlegm (mucus) in my chest at all \| My chest is completely full of phlegm (mucus), My chest does not feel tight at all \| My chest feels very tight, When I walk up a hill or one flight of stairs, I am not breathless \| When I walk up a hill or one flight of stairs, I am very breathless, I am not limited doing any activities at home\| I am very limited doing activities at home, I am confident leaving my home despite my lung condition\| I am not at all confident leaving my home because of my lung condition, I sleep soundly \| I don't sleep soundly because of my lung condition, I have lots of energy I have no energy at all. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Participation Differences by Individuals' Disease SeverityCOPD Assessment TestCAT ≥10122 participants
Participation Differences by Individuals' Disease SeverityCOPD Assessment TestCAT <1024 participants
Participation Differences by Individuals' Disease SeverityCOPD Assessment TestData missing2 participants
Participation Differences by (GOLD) ABCD ClassificationCOPD Assessment TestCAT <1022 participants
Participation Differences by (GOLD) ABCD ClassificationCOPD Assessment TestData missing1 participants
Participation Differences by (GOLD) ABCD ClassificationCOPD Assessment TestCAT ≥10107 participants
Quartile 1 - Mild Airflow ObstructionCOPD Assessment TestData missing1 participants
Quartile 1 - Mild Airflow ObstructionCOPD Assessment TestCAT <1010 participants
Quartile 1 - Mild Airflow ObstructionCOPD Assessment TestCAT ≥1026 participants
Quartile 2 - Moderate Airflow ObstructionCOPD Assessment TestCAT <105 participants
Quartile 2 - Moderate Airflow ObstructionCOPD Assessment TestCAT ≥1032 participants
Quartile 2 - Moderate Airflow ObstructionCOPD Assessment TestData missing0 participants
Quartile 3 - Severe Airflow ObstructionCOPD Assessment TestCAT <106 participants
Quartile 3 - Severe Airflow ObstructionCOPD Assessment TestData missing1 participants
Quartile 3 - Severe Airflow ObstructionCOPD Assessment TestCAT ≥1030 participants
Quartile 4 - Very Severe Airflow ObstructionCOPD Assessment TestData missing0 participants
Quartile 4 - Very Severe Airflow ObstructionCOPD Assessment TestCAT ≥1034 participants
Quartile 4 - Very Severe Airflow ObstructionCOPD Assessment TestCAT <103 participants
Group A - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestData missing0 participants
Group A - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestCAT ≥1018 participants
Group A - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestCAT <108 participants
Group B - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestCAT ≥1044 participants
Group B - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestCAT <106 participants
Group B - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestData missing0 participants
Group C - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestCAT <105 participants
Group C - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestCAT ≥109 participants
Group C - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestData missing0 participants
Group D - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestData missing1 participants
Group D - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestCAT <103 participants
Group D - Breathlessness Burden and Exacerbation RiskCOPD Assessment TestCAT ≥1036 participants
p-value: 0.31ANOVA
Secondary

FEV1/FVC

Individuals FEV1-to-forced vital capacity (FVC) ratio

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Participation Differences by Individuals' Disease SeverityFEV1/FVC49.1 Measured ratioStandard Deviation 11.8
Participation Differences by (GOLD) ABCD ClassificationFEV1/FVC49.0 Measured ratioStandard Deviation 11.9
Quartile 1 - Mild Airflow ObstructionFEV1/FVC60.5 Measured ratioStandard Deviation 8.5
Quartile 2 - Moderate Airflow ObstructionFEV1/FVC53.8 Measured ratioStandard Deviation 8.5
Quartile 3 - Severe Airflow ObstructionFEV1/FVC44.1 Measured ratioStandard Deviation 8.9
Quartile 4 - Very Severe Airflow ObstructionFEV1/FVC38.1 Measured ratioStandard Deviation 7.9
Group A - Breathlessness Burden and Exacerbation RiskFEV1/FVC58.1 Measured ratioStandard Deviation 7.3
Group B - Breathlessness Burden and Exacerbation RiskFEV1/FVC47.9 Measured ratioStandard Deviation 11.2
Group C - Breathlessness Burden and Exacerbation RiskFEV1/FVC49.1 Measured ratioStandard Deviation 12.8
Group D - Breathlessness Burden and Exacerbation RiskFEV1/FVC44.5 Measured ratioStandard Deviation 12
p-value: 0ANOVA
Secondary

Forced Expiratory Volume in 1-sec (FEV1)

Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Participation Differences by Individuals' Disease SeverityForced Expiratory Volume in 1-sec (FEV1)49.6 percent predictedStandard Deviation 23.2
Participation Differences by (GOLD) ABCD ClassificationForced Expiratory Volume in 1-sec (FEV1)48.5 percent predictedStandard Deviation 20.7
Quartile 1 - Mild Airflow ObstructionForced Expiratory Volume in 1-sec (FEV1)79.0 percent predictedStandard Deviation 21.5
Quartile 2 - Moderate Airflow ObstructionForced Expiratory Volume in 1-sec (FEV1)55.6 percent predictedStandard Deviation 5.5
Quartile 3 - Severe Airflow ObstructionForced Expiratory Volume in 1-sec (FEV1)38.5 percent predictedStandard Deviation 4.8
Quartile 4 - Very Severe Airflow ObstructionForced Expiratory Volume in 1-sec (FEV1)25.2 percent predictedStandard Deviation 4.5
Group A - Breathlessness Burden and Exacerbation RiskForced Expiratory Volume in 1-sec (FEV1)66.0 percent predictedStandard Deviation 20.2
Group B - Breathlessness Burden and Exacerbation RiskForced Expiratory Volume in 1-sec (FEV1)47.1 percent predictedStandard Deviation 17.9
Group C - Breathlessness Burden and Exacerbation RiskForced Expiratory Volume in 1-sec (FEV1)50.8 percent predictedStandard Deviation 20.3
Group D - Breathlessness Burden and Exacerbation RiskForced Expiratory Volume in 1-sec (FEV1)37.8 percent predictedStandard Deviation 17
p-value: 0Kruskal-Wallis
Secondary

Godin Leisure Time Physical Activity Questionnaire

Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.

Time frame: Baseline

Population: Missing data n=8 for differences by individuals' disease severity and n=4 for differences by (GOLD) ABCD

ArmMeasureValue (MEAN)Dispersion
Participation Differences by Individuals' Disease SeverityGodin Leisure Time Physical Activity Questionnaire74.64 Total minutes of Moderate to Vigorous PAStandard Deviation 138.59
Participation Differences by (GOLD) ABCD ClassificationGodin Leisure Time Physical Activity Questionnaire101.86 Total minutes of Moderate to Vigorous PAStandard Deviation 194.49
Quartile 1 - Mild Airflow ObstructionGodin Leisure Time Physical Activity Questionnaire100.29 Total minutes of Moderate to Vigorous PAStandard Deviation 170.08
Quartile 2 - Moderate Airflow ObstructionGodin Leisure Time Physical Activity Questionnaire117.06 Total minutes of Moderate to Vigorous PAStandard Deviation 175.61
Quartile 3 - Severe Airflow ObstructionGodin Leisure Time Physical Activity Questionnaire42.78 Total minutes of Moderate to Vigorous PAStandard Deviation 90.57
Quartile 4 - Very Severe Airflow ObstructionGodin Leisure Time Physical Activity Questionnaire40.06 Total minutes of Moderate to Vigorous PAStandard Deviation 79.7
Group A - Breathlessness Burden and Exacerbation RiskGodin Leisure Time Physical Activity Questionnaire166.52 Total minutes of Moderate to Vigorous PAStandard Deviation 204.52
Group B - Breathlessness Burden and Exacerbation RiskGodin Leisure Time Physical Activity Questionnaire33.38 Total minutes of Moderate to Vigorous PAStandard Deviation 76.05
Group C - Breathlessness Burden and Exacerbation RiskGodin Leisure Time Physical Activity Questionnaire138.57 Total minutes of Moderate to Vigorous PAStandard Deviation 149.35
Group D - Breathlessness Burden and Exacerbation RiskGodin Leisure Time Physical Activity Questionnaire39.10 Total minutes of Moderate to Vigorous PAStandard Deviation 73.21
p-value: 0.04Kruskal-Wallis
Secondary

Modified Medical Research Council Questionnaire on Breathlessness

Self-reported intensity of activity related breathlessness as assessed by the modified Medical Research Council (mMRC) dyspnea scale (0-4). This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Participation Differences by Individuals' Disease SeverityModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-145 participants
Participation Differences by Individuals' Disease SeverityModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥2101 participants
Participation Differences by Individuals' Disease SeverityModified Medical Research Council Questionnaire on BreathlessnessData missing2 participants
Participation Differences by (GOLD) ABCD ClassificationModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-140 participants
Participation Differences by (GOLD) ABCD ClassificationModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥290 participants
Participation Differences by (GOLD) ABCD ClassificationModified Medical Research Council Questionnaire on BreathlessnessData missing0 participants
Quartile 1 - Mild Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥215 participants
Quartile 1 - Mild Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessData missing2 participants
Quartile 1 - Mild Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-120 participants
Quartile 2 - Moderate Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥222 participants
Quartile 2 - Moderate Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-115 participants
Quartile 2 - Moderate Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessData missing0 participants
Quartile 3 - Severe Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-17 participants
Quartile 3 - Severe Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥230 participants
Quartile 3 - Severe Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessData missing0 participants
Quartile 4 - Very Severe Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessData missing0 participants
Quartile 4 - Very Severe Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-13 participants
Quartile 4 - Very Severe Airflow ObstructionModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥234 participants
Group A - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-126 participants
Group A - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥20 participants
Group A - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessData missing0 participants
Group B - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessData missing0 participants
Group B - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-10 participants
Group B - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥250 participants
Group C - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessData missing0 participants
Group C - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥20 participants
Group C - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-114 participants
Group D - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessmMRC 0-10 participants
Group D - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessmMRC ≥240 participants
Group D - Breathlessness Burden and Exacerbation RiskModified Medical Research Council Questionnaire on BreathlessnessData missing0 participants
p-value: 0ANOVA
Secondary

Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months

An exacerbation was defined as a change in medication due to a COPD exacerbation (i.e., the prescription of prednisone or a medical action plan) as indicated in the medical chart or hospital admission due to a COPD exacerbation.

Time frame: baseline

ArmMeasureGroupValue (NUMBER)
Participation Differences by Individuals' Disease SeverityNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations92 participants
Participation Differences by Individuals' Disease SeverityNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission56 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations76 participants
Participation Differences by (GOLD) ABCD ClassificationNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission54 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations30 participants
Quartile 1 - Mild Airflow ObstructionNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission7 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations27 participants
Quartile 2 - Moderate Airflow ObstructionNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission10 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission18 participants
Quartile 3 - Severe Airflow ObstructionNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations19 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission21 participants
Quartile 4 - Very Severe Airflow ObstructionNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations16 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission0 participants
Group A - Breathlessness Burden and Exacerbation RiskNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations26 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations50 participants
Group B - Breathlessness Burden and Exacerbation RiskNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission0 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations0 participants
Group C - Breathlessness Burden and Exacerbation RiskNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission14 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 0-1 exacerbations0 participants
Group D - Breathlessness Burden and Exacerbation RiskNumber of Participants With Exacerbations Due to COPD in the Preceding 12 MonthsNumber of participants with 2+ or 1 exacerbations leading to hospital admission40 participants
Secondary

Satisfaction of Life Questionnaire

This 5 item questionnaire was used to measure participants' level of life satisfaction. The higher the score, the higher the sense of life satisfaction. A score from 5-9 indicated extremely dissatisfied, 10-14 is dissatisfied, 15-19 indicated slightly below average life satisfaction. 20-24 is the average score, 25-29 is a high score indicative of higher life satisfaction and a score between 30-35 is a very high score and represent very high life satisfaction.

Time frame: Baseline

Population: Missing data n=6 for differences by individuals' disease severity and n=6 for differences by (GOLD) ABCD

ArmMeasureValue (MEAN)Dispersion
Participation Differences by Individuals' Disease SeveritySatisfaction of Life Questionnaire18.62 total score on a scaleStandard Deviation 8.16
Participation Differences by (GOLD) ABCD ClassificationSatisfaction of Life Questionnaire18.38 total score on a scaleStandard Deviation 8.14
Quartile 1 - Mild Airflow ObstructionSatisfaction of Life Questionnaire22.51 total score on a scaleStandard Deviation 7.78
Quartile 2 - Moderate Airflow ObstructionSatisfaction of Life Questionnaire20.94 total score on a scaleStandard Deviation 7.68
Quartile 3 - Severe Airflow ObstructionSatisfaction of Life Questionnaire16.35 total score on a scaleStandard Deviation 7.23
Quartile 4 - Very Severe Airflow ObstructionSatisfaction of Life Questionnaire15.1 total score on a scaleStandard Deviation 7.87
Group A - Breathlessness Burden and Exacerbation RiskSatisfaction of Life Questionnaire22.50 total score on a scaleStandard Deviation 6.83
Group B - Breathlessness Burden and Exacerbation RiskSatisfaction of Life Questionnaire17.33 total score on a scaleStandard Deviation 8.1
Group C - Breathlessness Burden and Exacerbation RiskSatisfaction of Life Questionnaire21.67 total score on a scaleStandard Deviation 6.73
Group D - Breathlessness Burden and Exacerbation RiskSatisfaction of Life Questionnaire15.95 total score on a scaleStandard Deviation 8.26
p-value: 0ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026