A Phase 3 interventional study of Standard Smoking Cessation and Extended Nicotine Replacement Therapy in Smoking, Pulmonary Disease, Chronic Obstructive and Tobacco Use Disorder, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-06.
Sponsored by University of Kansas Medical Center · Phase 3, Interventional, and Treatment
Long-term NRT has not been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT, might prove to be a reasonable alternative to the standard approach of asking patients to quit immediately. The investigators believe that GMT with long-term NRT will reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates.
In this study, 398 smokers with COPD will be randomly assigned to either receive: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). The SC intervention will be based on a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (a nicotine patch plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The GMT intervention will consist of counseling, focused on medication adherence and smoking reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will compare the two treatments based on their effects on smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms, breathing function, and smoking-related hospitalizations or death. The investigators will also analyze the data in such a way that will be able to identify which patients are most likely to benefit from treatment. This analysis will allow patients to estimate their chances of success based on their own personal characteristics and which treatment they choose.
The investigators study addresses research priorities identified in recent smoking cessation guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder Advisory Committee. This study reflects the interests expressed by smokers in prior surveys and addresses the limited reach and effectiveness of traditional approaches to smoking cessation. If our GMT approach is effective, our study could change the recommendations provided in clinical practice guidelines and change the way that insurance companies pay for smoking cessation treatment. GMT could provide an alternative for millions of smokers with COPD who are not currently benefiting from traditional approaches to smoking cessation
BACKGROUND Smokers with chronic obstructive pulmonary disease (COPD) recognize the dangers of continued smoking and would like to quit, but for most of them the idea of going 'cold turkey' is too intimidating. Many of these smokers would like to cut back on the amount that they smoke as part of a longer term path to quitting. Long-term nicotine replacement therapy (NRT) might allow them to do this. Long-term NRT is safe; it can reduce the rewarding effects of cigarettes, reduce the amount that people smoke, and increase quit rates. Long-term NRT has not, however, been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to evaluate the relative benefits of a third option: guided maintenance therapy with long-term NRT. We believe that long-term NRT could reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates.
OBJECTIVES
METHODS In this study, we will randomize 398 smokers with COPD to one of two treatment arms: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). Participants in the SC arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. Participants in the GMT arm will receive counseling focused on medication adherence and smoking reduction plus 52 weeks of combined NRT. Outcomes will be measured at 3, 6 and 12 months post-randomization and will assess rates of smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, and clinical outcomes including respiratory symptoms, respiratory function, and smoking-related hospitalizations or death. In addition to directly comparing outcomes in the two treatment arms, our novel classification and regression tree analysis will allow us to identify subgroups of patients most likely to benefit from treatment and will allow patients to estimate their projected outcomes given their personal history and their choice of therapy.
PATIENT OUTCOMES (PROJECTED) This study will show how long-term NRT compares to a traditional smoking cessation program in helping smokers quit, reduce cigarette exposure, lower exposure to carcinogens, and reduce risk for death and hospitalizations. If our hypothesis is correct, this program could dramatically alter treatment choices for the millions of smokers in the United States with COPD that have been frustrated in their attempts to quit.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 398 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
Other: Standard Smoking Cessation · Drug: Nicotine replacement therapy
Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
Other: Extended Nicotine Replacement Therapy · Drug: Nicotine replacement therapy
Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
Also known as: nicotine patch, nicotine gum, nicotine lozenge
Smoking Abstinence (Point Prevalent)
7-day point prevalent abstinence at 12 months, confirmed by exhaled CO \<=10
Time frame: Month 12
Sustained Abstinence
6 month sustained abstinence as measured by self-report at 6 and 12 months and confirmed by CO at 6 and 12 months. Participants who were confirmed as non-smokers by carbon monoxide (CO) at both Month 6 and Month 12 were considered to have "6-month sustained abstinence."
Time frame: Month 6 through Month 12
Quit Attempts
Number of self-reported quit attempts over one year. At Month 3 and Month 6, participants reported the number of quit attempts in the last 3 months. At Month 12, participants reported the number of quit attempts in the last 6 months.
Time frame: Month 3, Month 6, Month 12
Average Cigarettes Per Day
Average number of cigarettes per day over one year. Participants were asked at Month 3, Month 6, and Month 12 "During the past 7 days, on those days that you smoked, what was the average number of cigarettes or little cigars smoked per day?"
Time frame: Month 3, Month 6, Month 12
Carbon Monoxide Exposure
Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million.
Time frame: Month 3, Month 6, Month 12
Carcinogen Exposure
Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL.
Time frame: Month 3, Month 6, Month 12
Respiratory Function
Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization.
Time frame: Month 12
Respiratory Symptoms
Respiratory symptoms as measured by the COPD Assessment Test (CAT) respiratory questionnaire. Participants completed this 8-item assessment at Month 3, Month 6, and Month 12. Scores range from 0 to 40, with higher levels indicating higher impact of COPD on well-being and daily life.
Time frame: Month 3, Month 6, Month 12
Respiratory-related Hospital Visits
Number of respiratory-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for respiratory-related problems at Month 3, Month 6, and Month 12
Time frame: Month 3, Month 6, Month 12
Cardiac-related Hospital Visits
Number of cardiac-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for cardiac-related problems at Month 3, Month 6, and Month 12.
Time frame: Month 3, Month 6, Month 12
7-day Abstinence
Self-reported and biochemically verified 7-day abstinence. Participants were asked at Month 3, Month 6, and Month 12, "Have you smoked any cigarettes or little cigars, even a puff, in the past 7 days?" They also completed an exhaled carbon monoxide lab test at Month 3, 6 and 12. Biochemical verification= exhaled CO \<=10 ppm. Month 12 biochemically verified abstinence is the primary outcome, and is not reported in this table.
Time frame: Month 3, Month 6, Month 12
Cotinine
Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine.
Time frame: Month 3, Month 6, Month 12
Average Cigarettes Per Day (Continued Smokers Only)
Average number of cigarettes per day over one year, among continued smokers. All participants were asked "During the past 7 days, on those days that you smoked, what was the average number of cigarettes smoked per day?" at Month 3, Month 6, and Month 12. This analysis looks at the number of cigarettes per day among participants who were still smoking.
Time frame: Month 3, Month 6, Month 12
Carbon Monoxide Exposure (Continued Smokers Only)
Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. This analysis looks at CO among those continuing to smoke.
Time frame: Month 3, Month 6, Month 12
Carcinogen Exposure (Continued Smokers Only)
Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. This analysis looks at NNAL among continuing smokers only.
Time frame: Month 3, Month 6, Month 12
Cotinine (Continued Smokers Only)
Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. This analysis looks at NNAL among continuing smokers only.
Time frame: Month 3, Month 6, Month 12
| Milestone | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Started | 198 | 200 |
| Completed | 197 | 197 |
| Not completed | 1 | 3 |
| Withdrew: Death | 1 | 3 |
7-day point prevalent abstinence at 12 months, confirmed by exhaled CO \<=10
| Participants | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Smoking Abstinence (Point Prevalent) | 23 | 24 |
6 month sustained abstinence as measured by self-report at 6 and 12 months and confirmed by CO at 6 and 12 months. Participants who were confirmed as non-smokers by carbon monoxide (CO) at both Month 6 and Month 12 were considered to have "6-month sustained abstinence."
| Participants | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Sustained Abstinence | 15 | 12 |
Number of self-reported quit attempts over one year. At Month 3 and Month 6, participants reported the number of quit attempts in the last 3 months. At Month 12, participants reported the number of quit attempts in the last 6 months.
| number of quit attempts | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 4.6 ± 6.54 | 3.7 ± 5.48 |
| Month 6 | 4.5 ± 6.86 | 4.8 ± 8.97 |
| Month 12 | 5.7 ± 8.59 | 6.2 ± 11.31 |
Average number of cigarettes per day over one year. Participants were asked at Month 3, Month 6, and Month 12 "During the past 7 days, on those days that you smoked, what was the average number of cigarettes or little cigars smoked per day?"
| cigarettes per day | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 7.9 ± 8.64 | 10.5 ± 8.64 |
| Month 6 | 8.1 ± 8.52 | 9.1 ± 9.45 |
| Month 12 | 8.5 ± 7.84 | 8.1 ± 8.33 |
Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million.
| parts per million (ppm) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 15.0 ± 12.62 | 17.4 ± 13.69 |
| Month 6 | 14.6 ± 11.85 | 15.4 ± 12.58 |
| Month 12 | 15.5 ± 11.14 | 13.8 ± 11.14 |
Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL.
| pg/mg creatinine | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 279.0 ± 353.42 | 320.1 ± 350.59 |
| Month 6 | 178.2 ± 221.26 | 186.0 ± 236.21 |
| Month 12 | 190.4 ± 233.22 | 183.5 ± 223.94 |
Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization.
| % of predicted | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Respiratory Function | 55.4 ± 19.25 | 56.8 ± 19.78 |
Respiratory symptoms as measured by the COPD Assessment Test (CAT) respiratory questionnaire. Participants completed this 8-item assessment at Month 3, Month 6, and Month 12. Scores range from 0 to 40, with higher levels indicating higher impact of COPD on well-being and daily life.
| units on a scale | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 17.8 ± 9.25 | 19.3 ± 8.68 |
| Month 6 | 17.9 ± 9.48 | 18.1 ± 8.51 |
| Month 12 | 17.5 ± 9.33 | 18.2 ± 9.37 |
Number of respiratory-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for respiratory-related problems at Month 3, Month 6, and Month 12
| Participants | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 — 0 Visits | 176 | 169 |
| Month 3 — 1 Visit | 11 | 15 |
| Month 3 — 2 or more Visits | 2 | 7 |
| Month 6 — 0 Visits | 152 | 154 |
| Month 6 — 1 Visit | 22 | 24 |
| Month 6 — 2 or more Visits | 7 | 7 |
| Month 12 — 0 Visits | 157 | 153 |
| Month 12 — 1 Visit | 18 | 20 |
| Month 12 — 2 or more Visits | 10 | 10 |
Number of cardiac-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for cardiac-related problems at Month 3, Month 6, and Month 12.
| Participants | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 — 0 Visits | 181 | 185 |
| Month 3 — 1 Visit | 7 | 6 |
| Month 3 — 2 or more Visits | 1 | 0 |
| Month 6 — 0 Visits | 171 | 180 |
| Month 6 — 1 Visit | 10 | 4 |
| Month 6 — 2 or more Visits | 0 | 1 |
| Month 12 — 0 Visits | 175 | 167 |
| Month 12 — 1 Visit | 8 | 12 |
| Month 12 — 2 or more Visits | 2 | 3 |
Self-reported and biochemically verified 7-day abstinence. Participants were asked at Month 3, Month 6, and Month 12, "Have you smoked any cigarettes or little cigars, even a puff, in the past 7 days?" They also completed an exhaled carbon monoxide lab test at Month 3, 6 and 12. Biochemical verification= exhaled CO \<=10 ppm. Month 12 biochemically verified abstinence is the primary outcome, and is not reported in this table.
| Participants | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3, self-report | 27 | 16 |
| Month 3, biochemically verified | 25 | 14 |
| Month 6, self-report | 28 | 20 |
| Month 6, biochemically verified | 25 | 19 |
| Month 12, self-report | 25 | 28 |
Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine.
| ng/mg creatinine | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 2652.5 ± 2675.18 | 3378.1 ± 3182.00 |
| Month 6 | 2390.7 ± 2842.07 | 3342.3 ± 3282.48 |
| Month 12 | 2159.0 ± 2989.46 | 2363.7 ± 2988.16 |
Average number of cigarettes per day over one year, among continued smokers. All participants were asked "During the past 7 days, on those days that you smoked, what was the average number of cigarettes smoked per day?" at Month 3, Month 6, and Month 12. This analysis looks at the number of cigarettes per day among participants who were still smoking.
| cigarettes per day | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 8.7 ± 8.84 | 11.4 ± 8.53 |
| Month 6 | 9.1 ± 8.62 | 9.9 ± 9.52 |
| Month 12 | 9.7 ± 7.64 | 9.3 ± 8.27 |
Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. This analysis looks at CO among those continuing to smoke.
| parts per million (ppm) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 16.4 ± 12.56 | 18.8 ± 13.23 |
| Month 6 | 16.0 ± 11.68 | 17.0 ± 12.49 |
| Month 12 | 17.4 ± 10.57 | 15.8 ± 10.73 |
Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. This analysis looks at NNAL among continuing smokers only.
| pg/mg creatinine | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 314.6 ± 373.23 | 337.6 ± 363.80 |
| Month 6 | 219.8 ± 236.30 | 217.1 ± 251.82 |
| Month 12 | 257.0 ± 234.83 | 247.5 ± 230.64 |
Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. This analysis looks at NNAL among continuing smokers only.
| ng/mg creatinine | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Month 3 | 2771.2 ± 2774.24 | 3305.8 ± 2859.90 |
| Month 6 | 2850.7 ± 2645.50 | 3502.2 ± 2978.67 |
| Month 12 | 2733.9 ± 2532.32 | 2782.7 ± 2583.60 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Smoking Cessation | 1/198 (0.5%) | 9/198 (4.5%) | 97/198 (49%) |
| Extended Nicotine Replacement Therapy | 3/200 (1.5%) | 8/200 (4%) | 163/200 (81.5%) |
| Event | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| RevascularizationCardiac disorders | 3/198 | 0/200 |
| ArrhythmiaCardiac disorders | 1/198 | 3/200 |
| Hospitalization for CHFCardiac disorders | 2/198 | 2/200 |
| TIACardiac disorders | 1/198 | 1/200 |
| StrokeCardiac disorders | 1/198 | 0/200 |
| Unstable anginaCardiac disorders | 1/198 | 0/200 |
| Mesenteric IschemiaCardiac disorders | 0/198 | 1/200 |
| Myocardial InfarctionCardiac disorders | 0/198 | 1/200 |
| Event | Standard Smoking Cessation | Extended Nicotine Replacement Therapy |
|---|---|---|
| Local skin reactionsProduct Issues | 44/198 | 81/200 |
| Upper GI symptomsProduct Issues | 32/198 | 62/200 |
| Sleep DisturbanceProduct Issues | 23/198 | 41/200 |
| Oral discomfortProduct Issues | 13/198 | 26/200 |
| Change in affect or state of arousalProduct Issues | 12/198 | 20/200 |
| HeadacheProduct Issues | 7/198 | 18/200 |
| Cardiovascular symptomsProduct Issues | 7/198 | 13/200 |
| HiccupsProduct Issues | 7/198 | 11/200 |
| Bad Taste in MouthProduct Issues | 4/198 | 11/200 |
| DizzinessProduct Issues | 3/198 | 11/200 |
| Age, Continuous(years) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy | Total |
|---|---|---|---|
| Mean | 56.3 ± 8.66 | 55.7 ± 9.88 | 55.9 ± 9.29 |
| Sex: Female, Male(Participants) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy | Total |
|---|---|---|---|
| Female | 111 | 127 | 238 |
| Male | 87 | 73 | 160 |
| Ethnicity (NIH/OMB)(Participants) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 5 | 13 |
| Not Hispanic or Latino | 190 | 195 | 385 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 3 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 47 | 35 | 82 |
| White | 113 | 123 | 236 |
| More than one race | 35 | 42 | 77 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy | Total |
|---|---|---|---|
| United States | 198 | 200 | 398 |
| Number of Quit Attempts in the Past 12 Months(number of quit attempts) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy | Total |
|---|---|---|---|
| Mean | 2.2 ± 5.09 | 1.9 ± 4.29 | 2.1 ± 4.70 |
| Cigarettes Smoked per Day(cigarettes per day) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy | Total |
|---|---|---|---|
| Mean | 22.1 ± 11.87 | 24.0 ± 12.58 | 23.0 ± 12.26 |
| Carbon Monoxide Exposure(parts per million) | Standard Smoking Cessation | Extended Nicotine Replacement Therapy | Total |
|---|---|---|---|
| Mean | 22.2 ± 13.12 | 22.7 ± 14.48 | 22.5 ± 13.81 |
6 further baseline measures are reported on the registry.
Plan to share: Yes — We will create a clean, de-identified copy of our dataset. It will be available to other researchers, upon request. We will make data available to users under a data sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be saved as SAS or SPSS files, saved to disk, encrypted, and mailed to users. A copy of our analytic code used to generate our primary outcomes paper(s) will also be available on request. Given that this study does not meet the threshold for data sharing requirements, the costs of data preparation and shipping will be borne by the requester.
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Pulmonary Disease, Chronic Obstructive→
University of Kansas Medical Center