Cystic Fibrosis in ChildrenNCT03839992
Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis
An observational study of Cystic Fibrosis in Children, run by Gelb, Arthur F., M.D. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- spirometry
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2018to 25 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Review pulmonary function and radiologic studies in retrospective records of heterozygote or homozygote patients with cystic fibrosis
Who may be able to join
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Arthur F Gelb MD
Lakewood, California, 90712
Arthur F Gelb, MD, 562-633-2204, afgelb@msn.com
Christine Fraser, 562-633-2204, familyfrase@msn.com
- Recruiting
Miller Children's Hospital and Long Beach Medical Center
Long Beach, California, 90806
Vicki C Masson, MD, 631-741-0549 ext. 6317410549, vicki.masson@gmail.com
Eli C Nussbaum, MD, 714-356-6830 ext. 6317410549, ENussbaum@memorialcare.org
About this study
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.
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.
Read the 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.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- spirometry
- Keywords
- abnormal FEF75, bronchiectasis, lung CT
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDiagnostic test
measure spirometry and lung CT
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Apr 2018
- Primary completion25 Apr 2027 (estimated)
- Study completion25 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelb, Arthur F., M.D.
- Collaborators
- Miller Children's & Women's Hospital Long Beach, Stony Brook University, The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Arthur Gelb, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839992
- Sponsor's protocol ID
- MHS #843-18
- Status last verified
- Oct 2023
- First submitted
- 11 Feb 2019
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All individual published data will be shared
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.
PubMed 5442364Gelb 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.
PubMed 4683321Gelb 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.
PubMed 4684043Hogg 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.
PubMed 28151425Lukic 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.
PubMed 26079395Masson 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.
PubMed 36914809
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03839992
- Acronym / sponsor ID
- MHS #843-18
- Conditions
- Cystic Fibrosis in Children
- Keywords
- abnormal FEF75, bronchiectasis, lung CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gelb, Arthur F., M.D.
- Collaborators
- Miller Children's & Women's Hospital Long Beach, Stony Brook University, The Hospital for Sick Children
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 25 Apr 2027 (estimated)
- Study completion
- 25 Nov 2027 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Review pulmonary function and radiologic studies in retrospective records of heterozygote or homozygote patients with cystic fibrosis
Key inclusion criteria (3 listed)
- 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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometrymeasure spirometry and lung CT | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Results publication: PubMed 5442364Mead J. The lung's "quiet zone". N Engl J Med. 1970 Jun 4;282(23):1318-9. doi: 10.1056/NEJM197006042822311. No abstract available.
- Results publication: PubMed 4683321Gelb 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.
- Results publication: PubMed 4684043Gelb 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.
- Results publication: PubMed 28151425Hogg 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.
- Results publication: PubMed 26079395Lukic 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.
- Derived from this study: PubMed 36914809Masson 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.
- Individual participant dataSharing planned: Yes. All individual published data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthur Gelb, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis in Children, run by Gelb, Arthur F., M.D. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur F Gelb, MD (562-565-5333 ext. 5625655333, afgelb@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839992, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.