NCT03839992

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Apr 2018Nov 2027

Study Start

First participant enrolled

April 25, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2027

Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

9 years

First QC Date

February 11, 2019

Last Update Submit

October 25, 2023

Conditions

Cystic Fibrosis in Children

Keywords

abnormal FEF75bronchiectasislung CT

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

spirometryDIAGNOSTIC_TEST

measure spirometry and lung CT

Eligibility Criteria

Age5 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Review pulmonary function and radiologic studies in retrospective records of heterozygote or homozygote patients with cystic fibrosis

You may qualify if:

  • Heterozygote or homozygote patients with cystic fibrosis with normal routine pre bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arthur F Gelb MD

Lakewood, California, 90712, United States

RECRUITING

Miller Children's Hospital and Long Beach Medical Center

Long Beach, California, 90806, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 5442364RESULT

  • 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.

    PMID: 4683321RESULT

  • 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.

    PMID: 4684043RESULT

  • 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.

    PMID: 28151425RESULT

  • 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.

    PMID: 26079395RESULT

  • 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.

    PMID: 36914809DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Arthur Gelb, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur F Gelb, MD

CONTACT

562-565-5333afgelb@msn.com

Vicki Masson, MD

CONTACT

631-741-0549vicki.masson@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

April 25, 2018

Primary Completion (Estimated)

April 25, 2027

Study Completion (Estimated)

November 25, 2027

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

All individual published data will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
when published
Access Criteria
published data

Locations

US(2)