COPD AsthmaPhase 3REDEFINENCT03137303
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
A Phase 3 study testing Spirometry at initial visit, Albuterol and Spirometry at 12-month follow-up in people with COPD Asthma, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic Error in COPD and Asthma patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Asthma
- What is being tested?
- Spirometry at initial visit, Albuterol and Spirometry at 12-month follow-up
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 30 Sep 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age ≥40 years of age
- 2. Use of a maintenance respiratory medication and one of the following in the past year:
- 3. Diagnosis of asthma and/or COPD
- 4. No spirometry test performed in the past 3 years
- 5. Past or current smoker or is exposed to tobacco
Who cannot join
- Unable to perform adequate spirometry
- Non-English speaking
- Pregnancy
- Plans to move from the Chicago Area within the next year
- Seen by pulmonary specialist in the past 3 years
- Any terminal illness with a life expectancy of <6 months
- Life threatening (e.g. intensive care admission and/or use of mechanical ventilation) respiratory failure event in the past year.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CCHHS
Chicago, Illinois, 60612
UI Health
Chicago, Illinois, 60612
About this study
The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic Error in COPD and Asthma patients.
Read the detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are common chronic lung diseases that are diagnosed in more than 30 million adults in the United States. However, diagnostic error (DE), is considered one of the most common and harmful of patient-safety problems by the Institute of Medicine, occur frequently with asthma and/or COPD and disproportionately affect minorities and the under-served. DE leads to lost opportunities to identify other chronic conditions, avoidable morbidity and mortality, unnecessary costs to patients and health systems, and poor quality of care. Shortness of breath or dyspnea, which is a common symptom in asthma and COPD, is also common for many other chronic conditions such as cardiovascular disease and obesity. A better understanding of the impact of DE and interventions to improve diagnostic accuracy in asthma and COPD are of particular importance for minorities and the under-served that are disproportionately affected by conditions leading to dyspnea.
Spirometry is a simple, mobile, and essential test that is recommended by all major national and international guidelines for the diagnosis of asthma and COPD. However it is well known that spirometry is not routinely used in the ambulatory primary care setting and minorities and the underserved population are less likely to have spirometry leading to greater prevalence of DE. It has been estimated that 30-50% of people with an existing diagnosis of asthma and COPD were found to be misdiagnosed. Many of these patients misdiagnosed with asthma and/or COPD receive unnecessary respiratory pharmacotherapy which can pose serious risks including pneumonia, cardiovascular events, and mortality. In the setting of DE, these are considered avoidable and unnecessary respiratory pharmacotherapy use in minorities and the underserved that are already disproportionately affected by cardiovascular disease increases the risk of poorer outcomes. There is also DE in the diagnosis of asthma versus COPD, as these are both clinically distinct respiratory disorders with nuances in treatment recommendations. It is reported that African-Americans are considered to have increasing COPD mortality and are disproportionately affected by asthma death rates. However, as spirometry is not routinely performed and DE is prevalent in asthma and COPD, a component of these poor outcomes may be attributable to missed or delayed diagnoses of other chronic conditions or misdiagnosis within asthma and COPD.
Barriers to the use of spirometry in primary care exist at provider and health systems levels. Previous studies show that primary care providers (PCPs) lack knowledge in existing guidelines and in implementing spirometry into primary care clinics. Beyond these barriers, PCPs struggle with logistical challenges such as time and workflow constraints with clinic visits lasting 15 minutes or less in patients with multiple chronic medical conditions. These predisposing and enabling factors explain why prior studies that included interventions to educate PCPs and incorporate spirometry by training personnel in primary care clinics have had limited results.
A new paradigm to improve guideline based care for asthma and COPD which includes spirometry is needed and can lead to a better understanding of DE and improved patient safety and patient-centered outcomes. Health Promoters or Community health workers (CHWs) have been supplementing medical care by disseminating appropriate health care practices for underserved minority populations. However, studies which include diagnostic evaluations with spirometry for asthma and COPD have not been performed. The REDEFINE program (Reducing Diagnostic Error to Improve PatieNt SafEty in COPD and Asthma) will incorporate health promoters working collaboratively with PCPs to address identified barriers to guideline based care which includes spirometry for the diagnosis of asthma and COPD for patients at risk for DE. We propose a comparative effectiveness study to better understand the epidemiology of DE and to evaluate the effectiveness and economic impact of providing the REDEFINE program to an underserved, predominantly minority population with a diagnosis of asthma and/or COPD at risk for DE.
- Conditions
- COPD Asthma
- Being tested
- Spirometry at initial visit, Albuterol, Spirometry at 12-month follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry at initial visitDevice
Also called KoKo Spirometer (Model 313120), 3 Liter Calibration Syringe
Initial visit for the intervention group, an initial demographics form and health questionnaires. To evaluate the breathing, a pre and post broncho dilator will be performed as well as a spirometry test.
AlbuterolDrug
Also called Albuterol, Ventolin, Proventil, Accuneb
The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.
Spirometry at 12-month follow-upDevice
Also called KoKo Spirometer (Model 313120), 3 Liter Calibration Syringe
At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry test and undergo the same spirometry protocol as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Patient Subject Usual Care | Placebo comparator | On the day of the outpatient visit, subjects will be advised to arrive 90 minutes prior to their clinic visit. The following will be performed.
1. Subject demographic and contact information
2. Co-morbid conditions
3. Smoking history
4. Medication history from patient and also from pharmacy used by subjects
5. A respiratory exacerbation history in the past year
6. Modified Medical Research Counsel (mMRC) dyspnea scale
7. Quality of life measures
Subjects will be advised to go to their clinics and be managed by their PCP thereafter.
At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry and undergo the same spirometry protocol as the intervention group. Receives: Drug: Albuterol; Device: Spirometry at 12-month follow-up |
| Patient-Subject Intervention | Experimental | On the day of the outpatient visit, subjects will be advised to arrive 90 minutes prior to their clinic visit in the same building as the clinic site. The following information will be collected and procedures will be performed:
1. Subject demographic and contact information
2. Co-morbid conditions
3. Smoking history
4. Medication history from patient and also from pharmacy used by subjects
5. A respiratory exacerbation history in the past year
6. Modified Medical Research Counsel (mMRC) dyspnea scale
7. Quality of life measures
8. Pre and post-bronchodilator using Albuterol (BD) spirometry Receives: Device: Spirometry at initial visit; Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Healthcare Visits
Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups
Measured: 1 year
Secondary outcomes (1)
Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results
determine differences in the accuracy of diagnosis between groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Jul 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (66)Papers the sponsor has linked to this study.
- Other trials for COPD AsthmaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Min Joo, MD MPH, University of Illinois Chicago
- Investigators
- Min Joo, MD MPH, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137303
- Sponsor's protocol ID
- 2016-1209
- Acronym
- REDEFINE
- Status last verified
- Feb 2024
- First submitted
- 14 Apr 2017
- Last updated
- 26 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akinbami LJ, Liu X. Chronic obstructive pulmonary disease among adults aged 18 and over in the United States, 1998-2009. NCHS Data Brief. 2011 Jun;(63):1-8.
PubMed 22142836Centers for Disease Control and Prevention (CDC). Vital signs: asthma prevalence, disease characteristics, and self-management education: United States, 2001--2009. MMWR Morb Mortal Wkly Rep. 2011 May 6;60(17):547-52.
PubMed 21544044Ball JR, Balogh E. Improving Diagnosis in Health Care: Highlights of a Report From the National Academies of Sciences, Engineering, and Medicine. Ann Intern Med. 2016 Jan 5;164(1):59-61. doi: 10.7326/M15-2256. Epub 2015 Sep 29. No abstract available.
PubMed 26414299Committee on Diagnostic Error in Health Care; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine; Balogh EP, Miller BT, Ball JR, editors. Improving Diagnosis in Health Care. Washington (DC): National Academies Press (US); 2015 Dec 29. Available from http://www.ncbi.nlm.nih.gov/books/NBK338596/
PubMed 26803862Singh H, Graber ML. Improving Diagnosis in Health Care--The Next Imperative for Patient Safety. N Engl J Med. 2015 Dec 24;373(26):2493-5. doi: 10.1056/NEJMp1512241. Epub 2015 Nov 11. No abstract available.
PubMed 26559457Khullar D, Jha AK, Jena AB. Reducing Diagnostic Errors--Why Now? N Engl J Med. 2015 Dec 24;373(26):2491-3. doi: 10.1056/NEJMp1508044. Epub 2015 Sep 23. No abstract available.
PubMed 26397948Global Initiative for Asthma. Global strategy for asthma management and prevention. Bethesda, MD, USA: GINA;2015
Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.
PubMed 21810710National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
PubMed 17983880Bolton CE, Ionescu AA, Edwards PH, Faulkner TA, Edwards SM, Shale DJ. Attaining a correct diagnosis of COPD in general practice. Respir Med. 2005 Apr;99(4):493-500. doi: 10.1016/j.rmed.2004.09.015. Epub 2004 Nov 11.
PubMed 15763457Damarla M, Celli BR, Mullerova HX, Pinto-Plata VM. Discrepancy in the use of confirmatory tests in patients hospitalized with the diagnosis of chronic obstructive pulmonary disease or congestive heart failure. Respir Care. 2006 Oct;51(10):1120-4.
PubMed 17005056Han MK, Kim MG, Mardon R, Renner P, Sullivan S, Diette GB, Martinez FJ. Spirometry utilization for COPD: how do we measure up? Chest. 2007 Aug;132(2):403-9. doi: 10.1378/chest.06-2846. Epub 2007 Jun 5.
PubMed 17550936Lee TA, Bartle B, Weiss KB. Spirometry use in clinical practice following diagnosis of COPD. Chest. 2006 Jun;129(6):1509-15. doi: 10.1378/chest.129.6.1509.
PubMed 16778268Mapel DW, Picchi MA, Hurley JS, Frost FJ, Petersen HV, Mapel VM, Coultas DB. Utilization in COPD: patient characteristics and diagnostic evaluation. Chest. 2000 May;117(5 Suppl 2):346S-53S. doi: 10.1378/chest.117.5_suppl_2.346s.
PubMed 10843975Miravitlles M, de la Roza C, Naberan K, Lamban M, Gobartt E, Martin A. Use of spirometry and patterns of prescribing in COPD in primary care. Respir Med. 2007 Aug;101(8):1753-60. doi: 10.1016/j.rmed.2007.02.019. Epub 2007 Apr 19.
PubMed 17448651
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
- ClinicalTrials.gov ID
- NCT03137303
- Acronym / sponsor ID
- REDEFINE / 2016-1209
- Conditions
- COPD Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 22 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic Error in COPD and Asthma patients.
Detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are common chronic lung diseases that are diagnosed in more than 30 million adults in the United States. However, diagnostic error (DE), is considered one of the most common and harmful of patient-safety problems by the Institute of Medicine, occur frequently with asthma and/or COPD and disproportionately affect minorities and the under-served. DE leads to lost opportunities to identify other chronic conditions, avoidable morbidity and mortality, unnecessary costs to patients and health systems, and poor quality of care. Shortness of breath or dyspnea, which is a common symptom in asthma and COPD, is also common for many other chronic conditions such as cardiovascular disease and obesity. A better understanding of the impact of DE and interventions to improve diagnostic accuracy in asthma and COPD are of particular importance for minorities and the under-served that are disproportionately affected by conditions leading to dyspnea.
Spirometry is a simple, mobile, and essential test that is recommended by all major national and international guidelines for the diagnosis of asthma and COPD. However it is well known that spirometry is not routinely used in the ambulatory primary care setting and minorities and the underserved population are less likely to have spirometry leading to greater prevalence of DE. It has been estimated that 30-50% of people with an existing diagnosis of asthma and COPD were found to be misdiagnosed. Many of these patients misdiagnosed with asthma and/or COPD receive unnecessary respiratory pharmacotherapy which can pose serious risks including pneumonia, cardiovascular events, and mortality. In the setting of DE, these are considered avoidable and unnecessary respiratory pharmacotherapy use in minorities and the underserved that are already disproportionately affected by cardiovascular disease increases the risk of poorer outcomes. There is also DE in the diagnosis of asthma versus COPD, as these are both clinically distinct respiratory disorders with nuances in treatment recommendations. It is reported that African-Americans are considered to have increasing COPD mortality and are disproportionately affected by asthma death rates. However, as spirometry is not routinely performed and DE is prevalent in asthma and COPD, a component of these poor outcomes may be attributable to missed or delayed diagnoses of other chronic conditions or misdiagnosis within asthma and COPD.
Barriers to the use of spirometry in primary care exist at provider and health systems levels. Previous studies show that primary care providers (PCPs) lack knowledge in existing guidelines and in implementing spirometry into primary care clinics. Beyond these barriers, PCPs struggle with logistical challenges such as time and workflow constraints with clinic visits lasting 15 minutes or less in patients with multiple chronic medical conditions. These predisposing and enabling factors explain why prior studies that included interventions to educate PCPs and incorporate spirometry by training personnel in primary care clinics have had limited results.
A new paradigm to improve guideline based care for asthma and COPD which includes spirometry is needed and can lead to a better understanding of DE and improved patient safety and patient-centered outcomes. Health Promoters or Community health workers (CHWs) have been supplementing medical care by disseminating appropriate health care practices for underserved minority populations. However, studies which include diagnostic evaluations with spirometry for asthma and COPD have not been performed. The REDEFINE program (Reducing Diagnostic Error to Improve PatieNt SafEty in COPD and Asthma) will incorporate health promoters working collaboratively with PCPs to address identified barriers to guideline based care which includes spirometry for the diagnosis of asthma and COPD for patients at risk for DE. We propose a comparative effectiveness study to better understand the epidemiology of DE and to evaluate the effectiveness and economic impact of providing the REDEFINE program to an underserved, predominantly minority population with a diagnosis of asthma and/or COPD at risk for DE.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Subject Usual Care | Placebo comparator | Drug: Albuterol, Device: Spirometry at 12-month follow-upOn the day of the outpatient visit, subjects will be advised to arrive 90 minutes prior to their clinic visit. The following will be performed. 1. Subject demographic and contact information 2. Co-morbid conditions 3. Smoking history 4. Medication history from patient and also from pharmacy used by subjects 5. A respiratory exacerbation history in the past year 6. Modified Medical Research Counsel (mMRC) dyspnea scale 7. Quality of life measures Subjects will be advised to go to their clinics and be managed by their PCP thereafter. At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry and undergo the same spirometry protocol as the intervention group. |
| Patient-Subject Intervention | Experimental | Device: Spirometry at initial visit, Drug: AlbuterolOn the day of the outpatient visit, subjects will be advised to arrive 90 minutes prior to their clinic visit in the same building as the clinic site. The following information will be collected and procedures will be performed: 1. Subject demographic and contact information 2. Co-morbid conditions 3. Smoking history 4. Medication history from patient and also from pharmacy used by subjects 5. A respiratory exacerbation history in the past year 6. Modified Medical Research Counsel (mMRC) dyspnea scale 7. Quality of life measures 8. Pre and post-bronchodilator using Albuterol (BD) spirometry |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Age ≥40 years of age
- 2. Use of a maintenance respiratory medication and one of the following in the past year:
- 3. Diagnosis of asthma and/or COPD
- 4. No spirometry test performed in the past 3 years
- 5. Past or current smoker or is exposed to tobacco
Key exclusion criteria (7 listed)
- Unable to perform adequate spirometry
- Non-English speaking
- Pregnancy
- Plans to move from the Chicago Area within the next year
- Seen by pulmonary specialist in the past 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirometry at initial visitAlso: KoKo Spirometer (Model 313120), 3 Liter Calibration SyringeInitial visit for the intervention group, an initial demographics form and health questionnaires. To evaluate the breathing, a pre and post broncho dilator will be performed as well as a spirometry test. | Device | Patient-Subject Intervention |
| AlbuterolAlso: Albuterol, Ventolin, Proventil, AccunebThe post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry. | Drug | Patient Subject Usual Care, Patient-Subject Intervention |
| Spirometry at 12-month follow-upAlso: KoKo Spirometer (Model 313120), 3 Liter Calibration SyringeAt the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry test and undergo the same spirometry protocol as the intervention group. | Device | Patient Subject Usual Care |
Primary outcome
Total Number of Healthcare Visits
Time frame: 1 year
Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups
1 secondary outcome
Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22142836Akinbami LJ, Liu X. Chronic obstructive pulmonary disease among adults aged 18 and over in the United States, 1998-2009. NCHS Data Brief. 2011 Jun;(63):1-8.
- Background: PubMed 21544044Centers for Disease Control and Prevention (CDC). Vital signs: asthma prevalence, disease characteristics, and self-management education: United States, 2001--2009. MMWR Morb Mortal Wkly Rep. 2011 May 6;60(17):547-52.
- Background: PubMed 26414299Ball JR, Balogh E. Improving Diagnosis in Health Care: Highlights of a Report From the National Academies of Sciences, Engineering, and Medicine. Ann Intern Med. 2016 Jan 5;164(1):59-61. doi: 10.7326/M15-2256. Epub 2015 Sep 29. No abstract available.
- Background: PubMed 26803862Committee on Diagnostic Error in Health Care; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine; Balogh EP, Miller BT, Ball JR, editors. Improving Diagnosis in Health Care. Washington (DC): National Academies Press (US); 2015 Dec 29. Available from http://www.ncbi.nlm.nih.gov/books/NBK338596/
- Background: PubMed 26559457Singh H, Graber ML. Improving Diagnosis in Health Care--The Next Imperative for Patient Safety. N Engl J Med. 2015 Dec 24;373(26):2493-5. doi: 10.1056/NEJMp1512241. Epub 2015 Nov 11. No abstract available.
- Background: PubMed 26397948Khullar D, Jha AK, Jena AB. Reducing Diagnostic Errors--Why Now? N Engl J Med. 2015 Dec 24;373(26):2491-3. doi: 10.1056/NEJMp1508044. Epub 2015 Sep 23. No abstract available.
- BackgroundGlobal Initiative for Asthma. Global strategy for asthma management and prevention. Bethesda, MD, USA: GINA;2015
- Background: PubMed 21810710Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.
- Background: PubMed 17983880National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
- Background: PubMed 15763457Bolton CE, Ionescu AA, Edwards PH, Faulkner TA, Edwards SM, Shale DJ. Attaining a correct diagnosis of COPD in general practice. Respir Med. 2005 Apr;99(4):493-500. doi: 10.1016/j.rmed.2004.09.015. Epub 2004 Nov 11.
- Background: PubMed 17005056Damarla M, Celli BR, Mullerova HX, Pinto-Plata VM. Discrepancy in the use of confirmatory tests in patients hospitalized with the diagnosis of chronic obstructive pulmonary disease or congestive heart failure. Respir Care. 2006 Oct;51(10):1120-4.
- Background: PubMed 17550936Han MK, Kim MG, Mardon R, Renner P, Sullivan S, Diette GB, Martinez FJ. Spirometry utilization for COPD: how do we measure up? Chest. 2007 Aug;132(2):403-9. doi: 10.1378/chest.06-2846. Epub 2007 Jun 5.
- Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2016Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Joo, MD MPH principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spirometry at initial visit, Albuterol and Spirometry at 12-month follow-up in people with COPD Asthma, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Healthcare Visits (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137303, which also lists 66 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024; AzTrials last refreshed its copy on 3 Nov 2026.