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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02994017
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: cardiopulmonary exercise testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis
Study Start Date : March 2012
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
cystic fibrosis patients Other: cardiopulmonary exercise testing
The Cardiopulmonary exercise testing (CPET) was performed at the beginning of the study, the same at each center. Each patient underwent a symptom-limited incremental exercise test on an ergometric bicycle (Ergoline-Ergometrics 800®). The protocol included a warm-up period of 3 min at 20 W followed by a progressively increasing work rate (WR) in a ramp fashion and then 3 min recovery. The ramped WR increment was individualized (range,8-30 W/min). during exercise, heart rate (HR) was monitored continuously by 12-lead ECG, and arterial oxygen saturation (SpO2) was measured by pulse oximetry (Nellcor N-395). The expired gases were analyzed with an Ergocard®, focusing on oxygen consumption(VO2), carbon dioxide production (VCO2), minute ventilation (VE), and tidal volume (VT).

Primary Outcome Measures :
  1. Survival [ Time Frame: at five years ]
    the survival is defined by the occurrence of death or lung transplantation.

Secondary Outcome Measures :
  1. 6 minute walking distance [ Time Frame: Every 12 months during 5 years ]
  2. body mass index calculation [ Time Frame: Every 12 months during 5 years ]
  3. sputum sample culture [ Time Frame: 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)

  4. pulmonary function testing with DLCO [ Time Frame: Every 12 months during 5 years ]
    diffusing lung capacity for carbon monoxide.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02994017

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Contact: Anne Prevotat, MD

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Hôpital Calmette, CHRU Recruiting
Lille, France
Principal Investigator: Anne Prevotat, MD         
Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: Anne Prevotat, MD University Hospital, Lille

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Responsible Party: University Hospital, Lille Identifier: NCT02994017     History of Changes
Other Study ID Numbers: 2011_31
2011-A01532-39 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
cystic fibrosis
Cardiopulmonary exercise testing
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases