An observational study in COPD, Emphysema, Asthma COPD Overlap and Emphysema, sponsored by Gelb, Arthur F., M.D.. Recruiting at 2 sites in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Gelb, Arthur F., M.D. · Observational
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).
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 60 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Gelb, Arthur F., M.D. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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As above
Inclusion Criteria:
Exclusion Criteria:other pulmonary or systemic diagnosis
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Based on clinical, pathologic, laboratory, physiologic and radiologic differences, patient groups can be described.
Other: As above: diagnosis: COPD, Emphysema, Asthma-COPD Overlap
Site and Mechanism(s) of Expiratory Airflow Limitation
Contribution of loss of lung lastic recoil vs intrinsic airway obstruction
Time frame: 4 years
Plan to share: Yes — Results of tests
Supporting information: Study protocol, Clinical study report
Time frame: As indicated for collaborration
Access criteria: within 2 weeks of testing
Started Jan 2017 (actual). Primary completion is estimated for Jan 2027, 120 months after the start.
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Pulmonary Disease, Chronic Obstructive →
Gelb, Arthur F., M.D.