Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

Last updated: October 25, 2023
Sponsor: Gelb, Arthur F., M.D.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cystic Fibrosis

Lung Disease

Scar Tissue

Treatment

spirometry

Clinical Study ID

NCT03839992
MHS #843-18
  • Ages 5-40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Heterozygote or homozygote patients with cystic fibrosis with normal routine prebronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%.

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: spirometry
Phase:
Study Start date:
April 25, 2018
Estimated Completion Date:
November 25, 2027

Study 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.

Connect with a study center

  • Arthur F Gelb MD

    Lakewood, California 90712
    United States

    Active - Recruiting

  • Miller Children's Hospital and Long Beach Medical Center

    Long Beach, California 90806
    United States

    Active - Recruiting

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