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NCT Number: NCT03839992

Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis in Children Bronchial Diseases Bronchiectasis Respiratory Tract Diseases

Age range

5 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arthur F Gelb MD, Lakewood, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Spirometry

Diagnostic Test

measure spirometry and lung CT

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur F Gelb, MD

CONTACT

[email protected]

562-565-5333 ext. 5625655333

Vicki Masson, MD

CONTACT

[email protected]

631-741-0549 ext. 5625655333

Sponsors and collaborators

Lead sponsor

Gelb, Arthur F., M.D.

Indiv

Collaborators

  • Miller Children's & Women's Hospital Long Beach
  • Stony Brook University
  • The Hospital for Sick Children

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2019
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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