Clinical trial NCT03241420: Utility of Lung Clearance Index Score As a Noninvasive Marker of Small Airways Disease
Official title: Utility of Lung Clearance Index Score As a Noninvasive Marker of Small Airways Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lung Disease
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic military deployers with deployment-related lung disease seen at National Jewish Health and healthy controls subjects.

Brief summary: To determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of small airways disease in adults with chronic lung conditions compared to healthy adults, adjusting for age, sex and smoking status.

Detailed description: Target Population and Enrollment. The study will recruit and consent 300 patients from our Occupational Medicine and Interstitial Lung/Rheumatology Clinics at National Jewish Health who have been referred for evaluation of chronic lung conditions. The healthy control group will comprise 300 volunteers who are at least 18 years of age, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment. Inclusion criteria for the group with chronic lung disease will include physician diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary fibrosis, asthma, coal mine dust lung disease, asbestosis), and age ≥18 years. Exclusion criteria will include recent myocardial infarction, stroke, eye surgery, chest/abdominal surgery (within past month), known thoracic, aortic, or cerebral aneurysm, or uncontrolled hypertension. Study participation will consist of one visit that will last between 90-120 minutes. The chronic lung disease group will fill out the informed consent and complete both LCI testing and spirometry. The healthy control group will complete informed consent, a brief questionnaire, LCI testing, and spirometry.

Eligibility criteria: Inclusion Criteria:

* physician diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary fibrosis, asthma, coal mine dust lung disease, asbestosis), and age ≥18 years.

The healthy control group will comprise 300 volunteers who are at least 18 years of age, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment

Exclusion Criteria:

* Exclusion criteria will include recent myocardial infarction, stroke, eye surgery, chest/abdominal surgery (within past month), known thoracic, aortic, or cerebral aneurysm, or uncontrolled hypertension.

Primary outcomes:
measure: Lung Clearance Index (LCI) technique can be used as a marker of small airways disease in adults with chronic lung conditions
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References:
citation: Zell-Baran LM, Krefft SD, Moore CM, Wolff J, Meehan R, Rose CS. Multiple breath washout: A noninvasive tool for identifying lung disease in symptomatic military deployers. Respir Med. 2021 Jan;176:106281. doi: 10.1016/j.rmed.2020.106281. Epub 2020 Dec 5.
citation: Zell-Baran LM, Krefft SD, Moore CM, Wolff J, Meehan R, Rose CS. Multiple breath washout test data for healthy controls. Data Brief. 2020 Dec 10;34:106641. doi: 10.1016/j.dib.2020.106641. eCollection 2021 Feb.