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 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.
|Official Title:||Changes in Lung Function Based on Differences in Spirometry Equipment Used in Children With Cystic Fibrosis|
- Comparison of Pulmonary Function (FVC, FEV1) on 2 different spirometers [ Time Frame: 1/1/2009-12/31/2010 ] [ Designated as safety issue: No ]
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)
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 group (which is the same age breakdown that is reported in the CF Foundation Data Report.)
|Study Start Date:||March 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
all subjects who are enrolled in an industry-sponsored study that utilizes a sponsor-supplied spirometer.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343524
|United States, New York|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Ran D Anbar, MD||State University of New York - Upstate Medical University|