Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01343524 · ClinicalTrials.gov registry record
Changes in Lung Function Based on Differences in Spirometry Equipment Used in Children With Cystic Fibrosis
A clinical trial, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- 14
- Enrollment target
NCT01343524: Completed study, sponsored by State University of New York - Upstate Medical University.
NCT01343524 is a clinical trial that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343524 has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
Study Summary
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.
Primary Outcome
We plan to compare a subject's FVC and FEV1 values obtained on the same day, within 15 minutes of each other, done on our familiar clinic spirometer and on the less familiar study spirometer. ASSESSMENT OF EFFICACY Primary Efficacy Parameters • FEV1 (L) Statistics We will compare the average FEV1 for study and non-study PFTs by using a Student's t-test. Additionally, we will compare the difference in PFT's among children in the 6-12 year old age groups, with those in the 13-17 year old age g
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-01 |
What the finished NCT01343524 record still lists
NCT01343524 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01343524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01343524 about?
NCT01343524 is a clinical study titled "Changes in Lung Function Based on Differences in Spirometry Equipment Used in Children With Cystic Fibrosis". 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...
What is the current status of trial NCT01343524?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2010-03. Estimated completion is 2012-01.
Who is sponsoring clinical trial NCT01343524?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia