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Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

NCT ID: NCT03839992

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-25

Study Completion Date

2027-11-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cystic Fibrosis in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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spirometry

measure spirometry and lung CT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

\-
Minimum Eligible Age

5 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Miller Children's & Women's Hospital Long Beach

OTHER

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Gelb, Arthur F., M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur Gelb, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Arthur F Gelb MD

Lakewood, California, United States

Site Status RECRUITING

Miller Children's Hospital and Long Beach Medical Center

Long Beach, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Arthur F Gelb, MD

Role: CONTACT

[email protected]
562-565-5333 ext. 5625655333

Vicki Masson, MD

Role: CONTACT

[email protected]
631-741-0549 ext. 5625655333

Facility Contacts

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Arthur F Gelb, MD

Role: primary

[email protected]
562-633-2204

Christine Fraser

Role: backup

[email protected]
562-633-2204

Vicki C Masson, MD

Role: primary

[email protected]
631-741-0549 ext. 6317410549

Eli C Nussbaum, MD

Role: backup

[email protected]
714-356-6830 ext. 6317410549

References

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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.

Reference Type RESULT
PMID: 5442364 (View on PubMed)

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.

Reference Type RESULT
PMID: 4683321 (View on PubMed)

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.

Reference Type RESULT
PMID: 4684043 (View on PubMed)

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.

Reference Type RESULT
PMID: 28151425 (View on PubMed)

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.

Reference Type RESULT
PMID: 26079395 (View on PubMed)

Masson VK, Nussbaum E, Gelb AF, Tashkin DP, Randhawa I, Nadel JA, Fireizen Y, De Celie-Germana JK, Madera D, Senanayake D. Isolated abnormal FEF75% detects unsuspected bronchiolar obstruction in CF children. Pediatr Res. 2023 Sep;94(3):1051-1056. doi: 10.1038/s41390-023-02532-2. Epub 2023 Mar 13.

Reference Type DERIVED
PMID: 36914809 (View on PubMed)

Other Identifiers

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MHS #843-18

Identifier Type: -

Identifier Source: org_study_id

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