Recruiting

Observational Study

Sponsor:

Gelb, Arthur F., M.D.

Code:

NCT03839992

Conditions

Cystic Fibrosis in Children

Eligibility Criteria

Sex: All

Age: 5 - 40

Healthy Volunteers: Not accepted

Interventions

spirometry

Study Details

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.

Conditions

Cystic Fibrosis in Children

Study ID

NCT03839992

Start date

Apr 25, 2018

Status verified date

Oct, 2023

Completion date

Nov 25, 2027

Anticipated

Primary completion date

Apr 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

spirometry

measure spirometry and lung CT

Primary outcome measure

  • Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Arthur F Gelb, MD

562-565-5333afgelb@msn.com

Vicki Masson, MD

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

Locations

Arthur F Gelb MD

Recruiting

Lakewood, California, United States, 90712

Contacts

Arthur F Gelb, MD

562-633-2204afgelb@msn.com

Christine Fraser

562-633-2204familyfrase@msn.com

Principal Investigator:

Arthur F Gelb, MD

Miller Children's Hospital and Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Vicki C Masson, MD

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

Eli C Nussbaum, MD

714-356-6830ENussbaum@memorialcare.org

Principal Investigator:

Vicki C Masson, MD

More Information

Sponsor

Gelb, Arthur F., M.D.

Last update posted

Oct 26, 2023

Last verified

Oct, 2023

Keywords

  • abnormal FEF75
  • bronchiectasis
  • lung CT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gelb, Arthur F., M.D. on 2023-10-26.