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Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03839992
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Gelb, Arthur F., M.D.

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.

Condition or disease Intervention/treatment
Cystic Fibrosis in Children Diagnostic Test: spirometry

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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.
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : April 25, 2020
Estimated Study Completion Date : April 25, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: spirometry
    measure spirometry and lung CT


Primary Outcome Measures :
  1. Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis [ Time Frame: 2 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



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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839992


Contacts
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Contact: Arthur F Gelb, MD 562-565-5333 ext 5625655333 afgelb@msn.com
Contact: Vicki Masson, MD 631-741-0549 ext 5625655333 vicki.masson@gmail.com

Locations
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United States, California
Miller Children`s Hospital and Long Beach Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Vicki C Masson, MD    631-741-0549 ext 6317410549    vicki.masson@gmail.com   
Contact: Eli C Nussbaum, MD    714-356-6830 ext 6317410549    ENussbaum@memorialcare.org   
Principal Investigator: Vicki C Masson, MD         
Sponsors and Collaborators
Gelb, Arthur F., M.D.
Investigators
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Principal Investigator: Arthur Gelb, MD University of California, Los Angeles

Publications of Results:
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Responsible Party: Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier: NCT03839992     History of Changes
Other Study ID Numbers: MHS #843-18
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual published data will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: when published
Access Criteria: published data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Gelb, Arthur F., M.D.:
abnormal FEF75
bronchiectasis
lung CT
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases