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

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ClinicalTrials.gov Identifier: NCT03263130
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Gelb, Arthur F., M.D.

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).

Condition or disease Intervention/treatment
COPD, Emphysema, Asthma COPD Overlap Emphysema Other: As above: diagnosis: COPD, Emphysema, Asthma-COPD Overlap

Detailed Description:

The investigators are interested in determining the predominant site of expiratory airflow limitation including large central airways vs small peripheral airways/alveoli. In mild to moderate obstructive airways disease and emphysema, I believe routine spirometry including FEV 1(L), FVC (L), and FEV 1/FVC % may be normal, despite expiratory airflow limitation in lung peripheral airways. I also want to determine whether the mechanism(s) of expiratory airflow limitation are related to measured loss of lung elastic recoil or intrinsic obstruction of small peripheral airways or both. It is also important to determine the extent and distribution of emphysema using high resolution, thin section lung CT with voxel quantification. If available pathological analysis of lung surgical specimens and also formalin inflated lungs obtained at autopsy will also be studied. Blood studies will include but not limited to CBC, serum IgE, complete metabolic panel, and alpha 1 antitrypsin levels. Extensive lung function testing will also include spirometry tests before and after inhaled albuterol bronchodilation, lung volumes measured in a plethysmograph, diffusing capacity, measurement of lung elasticity that requires placement of an esophageal balloon, measurement of airflow after breathing a mixture of 80% helium-20%oxygen for 7-10 minutes, and measurements of exhaled nitric oxide. CAT scans of the lungs will be obtained to evaluate the presence, extent and distribution of emphysema and bronchiectasis. In some cases, bronchoscopy may be requested.

The above tests may be uncomfortable but should cause no harm.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Months
Official Title: Site and Mechanism(s) of Expiratory Airflow Limitation in COPD, Emphysema and Asthma-COPD Overlap
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Emphysema

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Site and Mechanism(s) of Expiratory Airflow Limitation [ Time Frame: within 2 years ]
    Contribution of loss of lung lastic recoil vs intrinsic airway obstruction



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
As above
Criteria

Inclusion Criteria:1. asthma- copd overlap 2. emphysema in smokers with smoking history > 15 pack years 3. COPD/ bronchitis and bronchiectasis in smokers with smoking history >15 pack years

Exclusion Criteria:other pulmonary or systemic diagnosis

  1. non smokers
  2. any other pulmonary diagnosis
  3. pulmonary fibrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263130


Contacts
Contact: Arthur F Gelb, MD 562-633-2204 afgelb@msn.com
Contact: Christine Fraser 562-633-2204 familyfrase@msn.com

Locations
United States, California
Arthur F Gelb MD Recruiting
Lakewood, California, United States, 90712
Contact: Arthur F Gelb, MD    562-633-2204    afgelb@msn.com   
Contact: Christine Fraser    562-633-2204    familyfrase@msn.com   
Principal Investigator: Arthur F Gelb, MD         
Arthur F Gelb MD Recruiting
Lakewood, California, United States, 90712
Contact: Arthur F Gelb, MD    562-633-2204    afgelb@msn.com   
Contact: Christine Fraser    562-633-2204    familyfrase@msn.com   
Sponsors and Collaborators
Gelb, Arthur F., M.D.
Investigators
Principal Investigator: Arthur F Gelb, MD Clin Prof Geffen School of Medicine at UCLA Medical Center
Study Director: Arthur F Gelb, MD Clin Prof Geffen School of Medicine at UCLA Medical Center

Publications:

Responsible Party: Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier: NCT03263130     History of Changes
Other Study ID Numbers: 1234567
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results of tests
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: As indicated for collaborration
Access Criteria: within 2 weeks of testing

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gelb, Arthur F., M.D.:
COPD, Emphysema, Asthma COPD Overlap

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Pulmonary Disease, Chronic Obstructive