Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03839992

Enrollment

100

Registered

2019-02-15

Start date

2018-04-25

Completion date

2027-11-25

Last updated

2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis in Children

Keywords

abnormal FEF75, bronchiectasis, lung CT

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTspirometry

measure spirometry and lung CT

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 40 Years

Healthy volunteers

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis	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

Countries

United States

Contacts

Primary ContactArthur F Gelb, MD

afgelb@msn.com562-565-5333

Backup ContactVicki Masson, MD

vicki.masson@gmail.com631-741-0549

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026