Site and Mechanism(s) of Expiratory Airflow Limitation in COPD, Emphysema and Asthma-COPD Overlap

NCT03263130 | Recruiting DMC

• 1 other identifier: 1234567
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this cross-sectional, observational study is to evaluate the site and mechanism(s) for expiratory airflow limitation in chronic, treated, current or former smokers (\>15 pack years) with COPD, Emphysema, and Asthma-COPD Overlap with mild to severe expiratory airflow limitation. Treatment may include short and long acting inhaled beta2agonists, short and long acting inhaled muscarinic receptor antagonists, inhaled and or oral corticosteroid, oral antibiotic, supplemental oxygen, and PDE type 4 inhibitor. In some cases, the patient may have had a history of asthma preceding the development of COPD (Asthma COPD Overlap).

Conditions

COPD, Emphysema, Asthma COPD Overlap; Emphysema

Keywords

COPD, Emphysema, Asthma COPD Overlap

Outcome Measures

Primary Outcomes (1)

• Site and Mechanism(s) of Expiratory Airflow Limitation

  Contribution of loss of lung lastic recoil vs intrinsic airway obstruction

  4 years

Study Arms (1)

COPD, Emphysema, Asthma-COPD Overlap

Based on clinical, pathologic, laboratory, physiologic and radiologic differences, patient groups can be described.

Other: As above: diagnosis: COPD, Emphysema, Asthma-COPD Overlap

Interventions

As above: diagnosis: COPD, Emphysema, Asthma-COPD Overlap OTHER

COPD, Emphysema, Asthma-COPD Overlap

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As above

You may qualify if:

• asthma- copd overlap
• emphysema in smokers with smoking history \> 15 pack years
• COPD/ bronchitis and bronchiectasis in smokers with smoking history
• \>15 pack years

You may not qualify if:

• non smokers
• any other pulmonary diagnosis
• pulmonary fibrosis

Sponsors & Collaborators

• Gelb, Arthur F., M.D.: lead

Study Sites (2)

Arthur F Gelb MD

Lakewood, California, 90712, United States

RECRUITING

Arthur F Gelb MD

Lakewood, California, 90712, United States

RECRUITING

Related Publications (18)

• 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.

  PMID: 21810710 RESULT

• Alcaide AB, Sanchez-Salcedo P, Bastarrika G, Campo A, Berto J, Ocon MD, Fernandez-Montero A, Celli BR, Zulueta JJ, de-Torres JP. Clinical Features of Smokers With Radiological Emphysema But Without Airway Limitation. Chest. 2017 Feb;151(2):358-365. doi: 10.1016/j.chest.2016.10.044. Epub 2016 Nov 3.

  PMID: 27818328 RESULT

• Mannino DM, Make BJ. Is it time to move beyond the "O" in early COPD? Eur Respir J. 2015 Dec;46(6):1535-7. doi: 10.1183/13993003.01436-2015. No abstract available.

  PMID: 26621878 RESULT

• Rennard SI, Drummond MB. Early chronic obstructive pulmonary disease: definition, assessment, and prevention. Lancet. 2015 May 2;385(9979):1778-1788. doi: 10.1016/S0140-6736(15)60647-X.

  PMID: 25943942 RESULT

• Harvey BG, Strulovici-Barel Y, Kaner RJ, Sanders A, Vincent TL, Mezey JG, Crystal RG. Risk of COPD with obstruction in active smokers with normal spirometry and reduced diffusion capacity. Eur Respir J. 2015 Dec;46(6):1589-1597. doi: 10.1183/13993003.02377-2014. Epub 2015 Nov 5.

  PMID: 26541521 RESULT

• Johns DP, Walters JA, Walters EH. Diagnosis and early detection of COPD using spirometry. J Thorac Dis. 2014 Nov;6(11):1557-69. doi: 10.3978/j.issn.2072-1439.2014.08.18.

  PMID: 25478197 RESULT

• Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R 3rd, Rennard S, Tashkin DP, Han MK; SPIROMICS Research Group. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811-21. doi: 10.1056/NEJMoa1505971.

  PMID: 27168432 RESULT

• Rodriguez-Roisin R, Han MK, Vestbo J, Wedzicha JA, Woodruff PG, Martinez FJ. Chronic Respiratory Symptoms with Normal Spirometry. A Reliable Clinical Entity? Am J Respir Crit Care Med. 2017 Jan 1;195(1):17-22. doi: 10.1164/rccm.201607-1376PP. No abstract available.

  PMID: 27598473 RESULT

• Martinez CH, Diaz AA, Meldrum C, Curtis JL, Cooper CB, Pirozzi C, Kanner RE, Paine R 3rd, Woodruff PG, Bleecker ER, Hansel NN, Barr RG, Marchetti N, Criner GJ, Kazerooni EA, Hoffman EA, Ross BD, Galban CJ, Cigolle CT, Martinez FJ, Han MK; SPIROMICS Investigators. Age and Small Airway Imaging Abnormalities in Subjects with and without Airflow Obstruction in SPIROMICS. Am J Respir Crit Care Med. 2017 Feb 15;195(4):464-472. doi: 10.1164/rccm.201604-0871OC.

  PMID: 27564413 RESULT

• Regan EA, Lynch DA, Curran-Everett D, Curtis JL, Austin JH, Grenier PA, Kauczor HU, Bailey WC, DeMeo DL, Casaburi RH, Friedman P, Van Beek EJ, Hokanson JE, Bowler RP, Beaty TH, Washko GR, Han MK, Kim V, Kim SS, Yagihashi K, Washington L, McEvoy CE, Tanner C, Mannino DM, Make BJ, Silverman EK, Crapo JD; Genetic Epidemiology of COPD (COPDGene) Investigators. Clinical and Radiologic Disease in Smokers With Normal Spirometry. JAMA Intern Med. 2015 Sep;175(9):1539-49. doi: 10.1001/jamainternmed.2015.2735.

  PMID: 26098755 RESULT

• Gelb AF, Hogg JC, Muller NL, Schein MJ, Kuei J, Tashkin DP, Epstein JD, Kollin J, Green RH, Zamel N, Elliott WM, Hadjiaghai L. Contribution of emphysema and small airways in COPD. Chest. 1996 Feb;109(2):353-9. doi: 10.1378/chest.109.2.353.

  PMID: 8620705 RESULT

• Gelb AF, Schein M, Kuei J, Tashkin DP, Muller NL, Hogg JC, Epstein JD, Zamel N. Limited contribution of emphysema in advanced chronic obstructive pulmonary disease. Am Rev Respir Dis. 1993 May;147(5):1157-61. doi: 10.1164/ajrccm/147.5.1157.

  PMID: 8484625 RESULT

• Gelb AF, Yamamoto A, Verbeken EK, Nadel JA. Unraveling the Pathophysiology of the Asthma-COPD Overlap Syndrome: Unsuspected Mild Centrilobular Emphysema Is Responsible for Loss of Lung Elastic Recoil in Never Smokers With Asthma With Persistent Expiratory Airflow Limitation. Chest. 2015 Aug;148(2):313-320. doi: 10.1378/chest.14-2483.

  PMID: 25950858 RESULT

• Gelb AF, Gold WM, Wright RR, Bruch HR, Nadel JA. Physiologic diagnosis of subclinical emphysema. Am Rev Respir Dis. 1973 Jan;107(1):50-63. doi: 10.1164/arrd.1973.107.1.50. No abstract available.

  PMID: 4683321 RESULT

• Gelb AF, Zamel N. Simplified diagnosis of small-airway obstruction. N Engl J Med. 1973 Feb 22;288(8):395-8. doi: 10.1056/NEJM197302222880805. No abstract available.

  PMID: 4684043 RESULT

• Gelb AF, Williams AJ, Zamel N. Spirometry. FEV1 vs FEF25-75 percent. Chest. 1983 Oct;84(4):473-4. doi: 10.1378/chest.84.4.473. No abstract available.

  PMID: 6617285 RESULT

• Gelb AF, Yamamoto A, Mauad T, Kollin J, Schein MJ, Nadel JA. Unsuspected mild emphysema in nonsmoking patients with chronic asthma with persistent airway obstruction. J Allergy Clin Immunol. 2014 Jan;133(1):263-5.e1-3. doi: 10.1016/j.jaci.2013.09.045. Epub 2013 Nov 28. No abstract available.

  PMID: 24290280 RESULT

• Gelb AF, Yamamoto A, Verbeken EK, Schein MJ, Moridzadeh R, Tran D, Fraser C, Barbers R, Elatre W, Koss MN, Glassy EF, Nadel JA. Further Studies of Unsuspected Emphysema in Nonsmoking Patients With Asthma With Persistent Expiratory Airflow Obstruction. Chest. 2018 Mar;153(3):618-629. doi: 10.1016/j.chest.2017.11.016. Epub 2017 Nov 29.

  PMID: 29197547 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur F Gelb, MD

  Clin Prof Geffen School of Medicine at UCLA Medical Center

  PRINCIPAL INVESTIGATOR

• Arthur F Gelb, MD

  Clin Prof Geffen School of Medicine at UCLA Medical Center

  STUDY DIRECTOR

Central Study Contacts

Arthur F Gelb, MD

CONTACT

562-633-2204; afgelb@msn.com

Christine Fraser

CONTACT

562-633-2204; familyfrase@msn.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 28, 2017
• Study Start: January 1, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: As indicated for collaborration
• Access Criteria: within 2 weeks of testing

Locations

US (2)