To determine if home spirometry (FEV1) predicts pulmonary exacerbation of CF before symptoms appear.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Analysis of home measured FEV1 before, during and after a antibiotic treatment
(excacerbation). A decrease of 10% or more of the FEV1 compared to the personal
best on 3 days in a row, or a decrease wich is slowl progressive in 7 days, and
results in a decrease of 10% or more in FEV1 is defined as a clinical relavent
decrease in pulmonary function.
Secondary outcome
not applicable
Background summary
Cystic Fibrosis is a chronic disease with destruction of lung in time due to
mucus plugging, and recurrent bacterial infections. One of the main goals in
therapy in CF is to treat pulmonary infections. These infections are diagnosed
on complaints and pulmonary function especially the forced expiratory volume in
the first second(FEV1). In this study we want to research if home measurement
of FEV1 is a reliable early indicator of pulmonary infections in CF.
Study objective
To determine if home spirometry (FEV1) predicts pulmonary exacerbation of CF
before symptoms appear.
Study design
longitudinal observational study
Study burden and risks
The patients have to perform a FEV1 once a day, every day, during 1 year. And
they have to point out their state of CF-well being in a visual analogue scale.
There are no risks in using a home spirometry device.
postbus 30001
9700 RB Groningen
Nederland
postbus 30001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Cystic Fibrosis
Able to perform spirometry
age 4-18 years old
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21161.042.08 |