- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839992
Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis
October 25, 2023 updated by: Gelb, Arthur F., M.D.
The Measurement and Analysis of Maximal Expiratory Flow Volume Loops at Low Lung Volumes in Children With Cystic Fibrosis and Normal Routine Lung Function.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arthur F Gelb, MD
- Phone Number: 5625655333 562-565-5333
- Email: afgelb@msn.com
Study Contact Backup
- Name: Vicki Masson, MD
- Phone Number: 5625655333 631-741-0549
- Email: vicki.masson@gmail.com
Study Locations
-
-
California
-
Lakewood, California, United States, 90712
- Recruiting
- Arthur F Gelb MD
-
Contact:
- Arthur F Gelb, MD
- Phone Number: 562-633-2204
- Email: afgelb@msn.com
-
Contact:
- Christine Fraser
- Phone Number: 562-633-2204
- Email: familyfrase@msn.com
-
Principal Investigator:
- Arthur F Gelb, MD
-
Long Beach, California, United States, 90806
- Recruiting
- Miller Children's Hospital and Long Beach Medical Center
-
Contact:
- Vicki C Masson, MD
- Phone Number: 6317410549 631-741-0549
- Email: vicki.masson@gmail.com
-
Contact:
- Eli C Nussbaum, MD
- Phone Number: 6317410549 714-356-6830
- Email: ENussbaum@memorialcare.org
-
Principal Investigator:
- Vicki C Masson, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Review pulmonary function and radiologic studies in retrospective records of heterozygote or homozygote patients with cystic fibrosis
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Arthur Gelb, MD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2018
Primary Completion (Estimated)
April 25, 2027
Study Completion (Estimated)
November 25, 2027
Study Registration Dates
First Submitted
February 11, 2019
First Submitted That Met QC Criteria
February 11, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHS #843-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All individual published data will be shared
IPD Sharing Time Frame
when published
IPD Sharing Access Criteria
published data
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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