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Clinical trialNCT01343524CompletedObservational

Changes in Lung Function Based on Differences in Spirometry Equipment Used in Children With Cystic Fibrosis

SponsorState University of New York - Upstate Medical UniversityEnrollment14Cystic Fibrosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The investigators' Upstate Cystic fibrosis (CF) Care Center is very active in research. For example, in 2009, 68 of our 135 pediatric patients have been participating in 16 clinical trials. Sponsors often provide their study sites with spirometers to use for PFTs. These machines are meant to provide uniform PFTs results for studies, which include measurement of FEV1 values. In 2009, among the 52 patients at our Center who are 6-12 years old, 20 (38%) have been in studies with sponsor-provided spirometers. Among the 32 patients ages 13-17 years, 13 (40%) have been in studies with sponsor-provided spirometers. Anecdotally, the investigators have noted that FEV1 results obtained during clinical trials for our patients appear to be lower than those of our patients' usual values, especially with younger children. The investigators hypothesize that the apparent difference in PFT results might be related to the different incentives (if any) provided by study PFT equipment. Further, if this difference exists, the investigators believe that this may account for the apparent average decline in the lung function results of our patients over the recent years, given the large proportion of our patients who participate in clinical trials. Finally, the investigators hypothesize that younger children may be more affected by the difference in incentives than older ones. The purpose of this study is to collect an additional set of Pulmonary Function Tests (PFTs) using our regular clinic equipment, on all study subjects following their study PFTs if these are done with sponsor-provided equipment. The investigators will compare the results from both types of machines and report regarding differences identified.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Ran D Anbar, MD

    State University of New York - Upstate Medical University

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Suny Upstate Medical University

    Syracuse, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2010
Primary completion
31 Dec 2010
Completion
31 Jan 2012
Last update posted
5 Jan 2012
Registered enrollment
14
Registry id
NCT01343524

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.