Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02994017 |
Other study ID # |
2011_31 |
Secondary ID |
2011-A01532-39 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 5, 2012 |
Est. completion date |
June 16, 2019 |
Study information
Verified date |
February 2023 |
Source |
University Hospital, Lille |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The objective of study is to prospectively determine if CPET with blood gas analysis should
have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients.
Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test
or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients
will perform a maximal exercise test on a cycloergometer during the inclusion visit, with
pulmonary function testing and a six-minute walk test. The study will also include a visit
every 6 months with: body mass index calculation, pulmonary function testing with DLCO
(diffusing lung capacity for carbon monoxide), a six minute walk test, and
antibacteriological study of sputum. The results of this study could help identify earlier
the patients for referral to a lung transplantation centre, by using the usual criteria and
the CPET abnormalities.
Description:
Current guidelines for referring cystic fibrosis (CF) patients for lung transplantation,
based on clinical and functional resting parameters, are insufficient to predict 3-year
mortality. Previous studies have shown that sex, impaired pulmonary function, undernutrition
and colonization of the respiratory tract by Pseudomonas aeruginosa are associated with a
poor prognosis. Current guidelines for referral to a lung transplant center include age, sex,
forced expiratory volume at one second (FEV1) below 30% predicted or a rapid decline of FEV1,
in particular in young female patients, increasing frequency of exacerbations requiring
antibiotic therapy, refractory or recurrent pneumothorax, recurrent hemoptysis not controlled
by embolization. But, despite these criteria, near that 30% of patients are still dying while
on the lung transplant waiting list, or are transplanted in high emergency. Cardiopulmonary
exercise testing (CPET) in CF patients would have an interest in the following of cystic
fibrosis patients. A previous study, carried out on fifty one adult patients, showed that
CPET with blood gas analysis may have a prognosis value in cystic fibrosis. The authors found
that a BMI < 19.8 and P(A-a)O2 peak > 43 mmHg were independently associated with a lower
chance of survival.