Status:
COMPLETED
Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis
Lead Sponsor:
Universidad San Jorge
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiother...
Detailed Description
All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before st...
Eligibility Criteria
Inclusion
- Pass the inhalation test
- Chronic sputum production, at least ≥ 10 ml /24h
- Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l)
- Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
- Trained in the use of autogenic drainage technique (at least 6 months)
- Inhaling hypertonic saline since at least 6 months
- To be able to provide written, informed consent and perform the protocol and the evaluations
Exclusion
- Active massive hemoptysis during the previous 2 months
- Patient in transplantation or retransplantation list
- Patient already participating in another study at the same time
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02303808
Start Date
December 1 2014
End Date
November 1 2015
Last Update
December 2 2015
Active Locations (1)
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1
Asociación Aragonesa de Fibrosis Quística
Zaragoza, Spain