An interventional study of Spirometry test and Levalbuterol in Chronic Obstructive Pulmonary Disease, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-12-24.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Health services research
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease that makes it harder to breathe over time. To date, there is no cure for COPD, but it can be managed when diagnosed and proper medical care is provided.
The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient outcomes (the condition of a patient's health) compared to usual care which may or may not include the use of spirometry. Spirometry is a standardized test used in medical practice that measures how much air your lungs can hold and how forcefully you can breathe out.
For this study, the investigators will compare two groups: 1) intervention (treatment) group and 2) usual care group (control). The intervention group will have a spirometry test and the results will be provided to the primary care physician. The usual care group will not initially have a spirometry test. Both groups will be followed for outcomes.
The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient associated outcomes compared to usual care which may or may not include the use of spirometry. To do this, we propose a comparative effectiveness trial of introducing a COPD assessment and management bundle targeted to primary care providers for patients suspected of having COPD versus usual care.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 56 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Patients, male and female, who are at least 40 years of age, receive primary treatment at the University of Illinois , and with any one of the following:
New Diagnosis
Inpatient or emergency department setting
New physician-diagnosis of COPD and/or new physician-diagnosis of asthma with a ≥10 pack year smoking without a spirometry 4 weeks or more after discharge from diagnosis setting.
Outpatient setting
Any patient with an existing physician-diagnosis of asthma within the past 2 years but > 6 months prior to the time of their visit and a ≥10 pack year smoking history, without a diagnosis of COPD, using a respiratory medication in the past year, and no spirometry on record or had a pre-bronchodilator spirometry with evidence of obstruction on record for at least the past 5 years.
Existing Diagnosis
Exclusion Criteria:
Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews.
Device: Spirometry test · Drug: Levalbuterol
Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference.
Device: Spirometry test · Drug: Levalbuterol
For the initial visit for the intervention group, an initial demographics form and a health questionnaire will given to the subject to complete. To evaluate the breathing and quality of living, a spirometry test will be performed that will evaluate how well and how fast the subject can breath and blow out air.
Also known as: KoKo Spirometer (Model 313105), 3 Liter Calibration Syringe
The spirometry test will be performed with a breathing medication called Levalbuterol (Xopenex®). Levalbuterol is used in standard practice for COPD and is commonly used during spirometry.
Also known as: Xopenex®: 4 puffs administered 30 seconds apart
Number of Participants With Accurate Classification of Irreversible Airflow Obstruction
accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was \<0.7.
Time frame: spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups
| Milestone | Usual Care | Intervention |
|---|---|---|
| Started | 22 | 34 |
| Completed | 22 | 34 |
| Not completed | 0 | 0 |
accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was \<0.7.
| Participants | COPD Assessment and Management Recommendations | Usual Care |
|---|---|---|
| Number of Participants With Accurate Classification of Irreversible Airflow Obstruction | 10 | 5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COPD Assessment and Management Recommendations | — | 0/34 (0%) | 0/34 (0%) |
| Usual Care | — | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | COPD Assessment and Management Recommendations | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 19 | 40 |
| >=65 years | 13 | 3 | 16 |
| Age, Continuous(years) | COPD Assessment and Management Recommendations | Usual Care | Total |
|---|---|---|---|
| Mean | 60.3 ± 10.1 | 57.0 ± 6.9 | 58.9 ± 7.2 |
| Sex: Female, Male(Participants) | COPD Assessment and Management Recommendations | Usual Care | Total |
|---|---|---|---|
| Female | 22 | 17 | 39 |
| Male | 12 | 5 | 17 |
| Region of Enrollment(participants) | COPD Assessment and Management Recommendations | Usual Care | Total |
|---|---|---|---|
| United States | 34 | 22 | 56 |
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago