Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients

Ospedale Civile Ca' Foncello

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Other: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%

Other: Inhalable Hypertonic saline 7%

Study type

Interventional

Funder types

Other

Identifiers

NCT01658449

HS/2009 HYANEB

Details and patient eligibility

About

The purpose of this study is to compare the tolerability and acceptability of a formulation containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance to HS.

Enrollment

40 patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

diagnosis of Cystic Fibrosis (genotyping and sweat test)
> 8 year-old
clinically and therapeutically stable disease in the last 30 days;
Forced Expiratory Volume in one second (FEV1) ≥ 50% of predicted value;
intolerance (cough, throat irritation, saltiness) to previous administration of 5.8% hypertonic saline solution.

Exclusion criteria

decrease in FEV1 >15% after first inhalation of hypertonic saline;
Burkholderia cepacia infection;
infective exacerbation requiring antibiotic treatment in the 15 days preceding enrolment;
patient non compliant to standard therapy;
Lung transplant;
Patient unable to perform reproducible spirometry;
Intolerance to β2 bronchodilators;
Concurrent enrolment in other clinical trials;
Plasmatic creatinine and transaminases more than twice the normal values.