Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: cardiopulmonary exercise testing

• Registration Number: NCT02994017
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-03-05
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Primary Completion: 2019-06-16
• Study Completion: 2019-06-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Age more than 15 years
• Cystic fibrosis diagnosed by positive sweat chloride test or genetic test

Exclusion Criteria

• Pregnant or breastfeeding woman
• waiting on transplantation list

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cystic fibrosis patients	cardiopulmonary exercise testing	-

Primary Outcome Measures

Name	Time	Method
Survival	at five years	the survival is defined by the occurrence of death or lung transplantation.

Secondary Outcome Measures

Name	Time	Method
sputum sample culture	Every 12 months during 5 years	(a descriptive analysis of Haemophilus influenzae, Staphylococcus aureus, Pseudomonas aeruginosa,Burkholderia cepacia streptococci in the bacterial flora of sputum)
6 minute walking distance	Every 12 months during 5 years
body mass index calculation	Every 12 months during 5 years
pulmonary function testing with DLCO	Every 12 months during 5 years	diffusing lung capacity for carbon monoxide.

Trial Locations

Locations (1)

Hôpital Calmette, CHRU; 🇫🇷 Lille, France