Clinical trial NCT01658449: Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Ospedale Civile Ca' Foncello
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the judgement on global pleasure of the inhalation between the two treatment groups
timeFrame: The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.
measure: Comparison of the symptom cough between the two treatment groups
timeFrame: The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.
measure: Comparison of the sensation of saltiness between the two treatment groups
timeFrame: The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.
measure: Comparison of the sensation of throat irritation between the two treatment groups
timeFrame: The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.
Secondary outcomes:
measure: Comparison of Delta FEV1 between the two treatment groups
timeFrame: day 1 and day 28 of the four-weeks treatment
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: centro Fibrosi Cistica
Study officials:
References:
citation: Ros M, Casciaro R, Lucca F, Troiani P, Salonini E, Favilli F, Quattrucci S, Sher D, Assael BM. Hyaluronic acid improves the tolerability of hypertonic saline in the chronic treatment of cystic fibrosis patients: a multicenter, randomized, controlled clinical trial. J Aerosol Med Pulm Drug Deliv. 2014 Apr;27(2):133-7. doi: 10.1089/jamp.2012.1034. Epub 2013 Jun 8.