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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ran Anbar, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01343524
First received: February 14, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition
Cystic Fibrosis

Study Type: Observational
Official Title: Changes in Lung Function Based on Differences in Spirometry Equipment Used in Children With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • 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)

    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 group (which is the same age breakdown that is reported in the CF Foundation Data Report.)



Enrollment: 14
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
all subjects
all subjects who are enrolled in an industry-sponsored study that utilizes a sponsor-supplied spirometer.

  Hide Detailed Description

Detailed Description:

Cystic fibrosis (CF) is an autosomal recessive genetic disease, characterized by pulmonary and sinus disease, gastrointestinal and reproductive tract dysfunction. CF patients suffer from chronic repeated cycles of pulmonary bacterial infection, pulmonary exacerbations and chronic lung function decline, which often lead to premature death. Although improved treatment of lung disease has increased survival, the median predicted age for survival is only 37.2 years in the United States (US) (CFF Annual Data Report, 2008) and patients continue to have significant morbidity, including hospitalizations (Ramsey, 1996).

Pulmonary Function Tests (PFTs) are used to measure and track lung health of patients with CF. Performing a PFT takes practice and requires patients to perform certain breathing maneuvers consistently. Infants and young children cannot be tested using spirometers. The investigators start PFT training with our patients after they reach 4 years of age. It may take several months to a few years for useful, consistent and interpretable PFTs to be obtained. According to standards developed by the American Thoracic Society, children must be able to breathe in very deeply, exhale fast and hard, and continue exhaling for several seconds. Children also must perform these maneuvers in a repeatable manner. (Ferris, 1978 ). Recent software programs have been developed to encourage and assist children in completing the breathing maneuvers. Videogame-like graphics respond to children's efforts. Children can often choose which "game" to play, such as, "Blow out the candles."

PFT results have taken on greater importance as new therapies are tested and evaluated. One component of the PFT is the FEV1 value (the amount of air exhaled in one second). Physicians, families and patients keep track of the FEV1 values and decreases are investigated carefully and addressed with treatment modification, if necessary. Many industry-sponsored and CF Foundation-sponsored protocols use FEV1 values in their exclusion and inclusion criteria for studies involving patients with CF. FEV1 is used to judge the efficacy of most investigational treatments. (In many studies, change in FEV1 is the only primary endpoint measured.)

Almost all of our patients with CF participate in the national CF Foundation (CFF)-sponsored CF Registry. Detailed clinical information is collected through the Registry and published each year in the CFF Annual Data Report and online, from which some of the information is accessible to the public. The Data Report is meant to be one way to compare outcomes at different CF Centers. Also, it is used locally to identify areas that need further improvement. In the recently published 2008 Data Report, the average FEV1 values for patients at our Center ages 6-12 years had decreased significantly from last year. This continues a trend the investigators have seen over the past 5 years, despite no apparent change in the treatment protocols at our Center. Nationally, FEV1 values for patients in this age range have stayed the same. This apparent local decrease was quite troubling to our Center staff and became a recent focus of our Quality Improvement efforts.

Our Upstate 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 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.

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will include CF patients enrolled in studies that require PFTs using study-provided spirometers. Any patient less than 22 years old, capable of performing PFTs for research studies, will be offered this study as well.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of cystic fibrosis (CF)
  • Enrolled in an industry-sponsored CF study that requires use of a sponsor-supplied spirometer
  • Capable of performing Pulmonary Function Test (PFT)
  • Less than 22 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343524

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Ran D Anbar, MD State University of New York - Upstate Medical University
  More Information

Publications:
Ramsey BW. Management of Pulmonary Disease in Patients with Cystic Fibrosis. N Engl J Med 1996; 335(3):179-188.

Responsible Party: Ran Anbar, Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01343524     History of Changes
Other Study ID Numbers: 5891
Study First Received: February 14, 2011
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
cystic fibrosis
spirometry
PFT's
pulmonary function test

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 02, 2014