Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

October 25, 2023 updated by: Gelb, Arthur F., M.D.

The Measurement and Analysis of Maximal Expiratory Flow Volume Loops at Low Lung Volumes in Children With Cystic Fibrosis and Normal Routine Lung Function.

Goal is to physiologically detect unsuspected small airways obstruction in children and adults with treated heterozygous and homozygous cystic fibrosis. Unsuspected refers to normal routine pre bronchodilator spirometry including normal FEV1(L), FVC (L). and FEV1/FVC%. This is a retrospective study.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

The current study is based on current investigators previously published patho-physiologic and lung CT studies in small airways intrinsic obstruction, emphysema, and asthma. Current investigators have demonstrated that despite the presence of normal routine spirometry including normal FEV1(L), FVC (L), and FEV1/FVC% that unsuspected small airways obstruction, and emphysema can be detected. This has been achieved by presence of isolated abnormal expiratory airflow limitation at low lung volumes on the maximal expiratory flow volume curves. This includes abnormal expiratory airflow at 75% and 80% expired lung volume. Current investigators believe investigators will be able to detect unsuspected small airways intrinsic obstruction, and peripheral airway bronchiectasis proven by lung CT, in patients with cystic fibrosis despite presence of pre bronchodilator normal routine spirometry.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Arthur F Gelb, MD
  • Phone Number: 5625655333 562-565-5333
  • Email: afgelb@msn.com

Study Contact Backup

Study Locations

    • California
      • Lakewood, California, United States, 90712
        • Recruiting
        • Arthur F Gelb MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arthur F Gelb, MD
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's Hospital and Long Beach Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vicki C Masson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Review pulmonary function and radiologic studies in retrospective records of heterozygote or homozygote patients with cystic fibrosis

Description

Inclusion Criteria:

Heterozygote or homozygote patients with cystic fibrosis with normal routine pre bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%.

Exclusion Criteria:Heterozygote or homozygote patients with cystic fibrosis with ABNORMAL routine pre bronchodilator spirometry

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis
Time Frame: 5 years
Retrospective analysis of pre bronchodilator spirometry, and lung CT study to detect abnormal FEF75% in the presence of normal spirometry and FEF25-75. Detect isolated abnormal pre bronchodilator spirometry at 75%FVC
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arthur Gelb, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Estimated)

April 25, 2027

Study Completion (Estimated)

November 25, 2027

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual published data will be shared

IPD Sharing Time Frame

when published

IPD Sharing Access Criteria

published data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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