ClinicalTrials.gov
ClinicalTrials.gov Menu

Utility of Lung Clearance Index Score as a Noninvasive Marker of Small Airways Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03241420
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Diana Pruitt, National Jewish Health

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.

Condition or disease Intervention/treatment Phase
Chronic Lung Disease Device: lung clearance index (LCI) Phase 3

Detailed Description:
Target Population and Enrollment. The study will recruit and consent 300 patients from our Occupational Medicine and Interstitial Lung Disease 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of lung injury/small airways disease in adults with chronic lung conditions compared to healthy adults, adjusting for age, sex, and smoking status.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utility of Lung Clearance Index Score as a Noninvasive Marker of Small Airways Disease
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Chronic Lung conditions
Study participation will consist of one visit: Informed consent, complete both Lung Clearance Index (LCI) testing and spirometry.
Device: lung clearance index (LCI)
Determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of lung injury/small airways disease in adults with chronic lung conditions compared to health adults, adjusting for age, sex, and smoking status.

Active Comparator: Healthy control group
Study participation will consist of one visit: Informed consent, brief questionnaire, LCI testing and spirometry.
Device: lung clearance index (LCI)
Determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of lung injury/small airways disease in adults with chronic lung conditions compared to health adults, adjusting for age, sex, and smoking status.




Primary Outcome Measures :
  1. Lung Clearance Index (LCI) technique can be used as a marker of small airways disease in adults with chronic lung conditions [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03241420


Contacts
Contact: Jenna Wolff, BA 303-398-1418 wolffj@njheatlh.org
Contact: Lauren Zell-Baran, MPH 303-398-1187 zell-baranl@njhealth.org

Locations
United States, Colorado
National Jewish Health Interstitial Lung Disease Program Recruiting
Denver, Colorado, United States, 80206
Contact: Jenna Wolff, BA    303-398-1418    wolffj@njhealth.org   
Contact: Lauren Zell-Baran, MPH    303-398-1187    zell-baranl@njhealth.org   
Sponsors and Collaborators
National Jewish Health

Responsible Party: Diana Pruitt, Principal Investigator, National Jewish Health
ClinicalTrials.gov Identifier: NCT03241420     History of Changes
Other Study ID Numbers: HS-2985
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive