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

Sponsor
Gelb, Arthur F., M.D. (Other)
Overall Status
Recruiting
CT.gov ID
NCT03263130
Collaborator
(none)
60
2
71
30
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Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Site and Mechanism(s) of Expiratory Airflow Limitation in COPD, Emphysema and Asthma-COPD Overlap
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Site and Mechanism(s) of Expiratory Airflow Limitation [4 years]

    Contribution of loss of lung lastic recoil vs intrinsic airway obstruction

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • asthma- copd overlap

  • emphysema in smokers with smoking history > 15 pack years

  • COPD/ bronchitis and bronchiectasis in smokers with smoking history

  • 15 pack years

Exclusion Criteria:other pulmonary or systemic diagnosis

  • non smokers

  • any other pulmonary diagnosis

  • pulmonary fibrosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arthur F Gelb MD Lakewood California United States 90712
2 Arthur F Gelb MD Lakewood California United States 90712

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier:
NCT03263130
Other Study ID Numbers:
  • 1234567
First Posted:
Aug 28, 2017
Last Update Posted:
Feb 8, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2021