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NCT03839992 Clinical Trial

Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

Cystic Fibrosis in Children Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03839992
Other study ID # MHS #843-18
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 25, 2018
Est. completion date November 25, 2027

Study information
Verified date October 2023
Source Gelb, Arthur F., M.D.
Contact Arthur F Gelb, MD
Phone 562-565-5333
Email afgelb@msn.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date November 25, 2027
Est. primary completion date April 25, 2027
Accepts healthy volunteers No
Gender All
Age group 5 Years to 40 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• spirometry
measure spirometry and lung CT

Locations
Country Name City State
United States Arthur F Gelb MD Lakewood California
United States Miller Children's Hospital and Long Beach Medical Center Long Beach California

Sponsors (4)
Lead Sponsor Collaborator
Gelb, Arthur F., M.D. Miller Children's & Women's Hospital Long Beach, Stony Brook University, The Hospital for Sick Children

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gelb AF, Gold WM, Wright RR, Bruch HR, Nadel JA. Physiologic diagnosis of subclinical emphysema. Am Rev Respir Dis. 1973 Jan;107(1):50-63. doi: 10.1164/arrd.1973.107.1.50. No abstract available. — View Citation

Gelb AF, Zamel N. Simplified diagnosis of small-airway obstruction. N Engl J Med. 1973 Feb 22;288(8):395-8. doi: 10.1056/NEJM197302222880805. No abstract available. — View Citation

Hogg JC, Pare PD, Hackett TL. The Contribution of Small Airway Obstruction to the Pathogenesis of Chronic Obstructive Pulmonary Disease. Physiol Rev. 2017 Apr;97(2):529-552. doi: 10.1152/physrev.00025.2015. Erratum In: Physiol Rev. 2018 Jul 1;98(3):1909. — View Citation

Lukic KZ, Coates AL. Does the FEF25-75 or the FEF75 have any value in assessing lung disease in children with cystic fibrosis or asthma? Pediatr Pulmonol. 2015 Sep;50(9):863-8. doi: 10.1002/ppul.23234. Epub 2015 Jun 16. — View Citation

Mead J. The lung's "quiet zone". N Engl J Med. 1970 Jun 4;282(23):1318-9. doi: 10.1056/NEJM197006042822311. No abstract available. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis 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
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