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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01658449
• Date of registration: 13/07/2012
• Prospective Registration: No
• Primary sponsor: Ospedale Civile Ca' Foncello
• Public title: Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients
• Date of first enrolment: December 2009
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01658449
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Phase: N/A

Countries of recruitment

Italy

Key inclusion & exclusion 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 ß2 bronchodilators;

- Concurrent enrolment in other clinical trials;

- Plasmatic creatinine and transaminases more than twice the normal values.



Age minimum: 8 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Other: Inhalable Hypertonic saline 7%

Other: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%

Primary Outcome(s)

Comparison of the judgement on global pleasure of the inhalation between the two treatment groups [Time Frame: 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.]

Comparison of the sensation of throat irritation between the two treatment groups [Time Frame: 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.]

Comparison of the symptom cough between the two treatment groups [Time Frame: 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.]

Comparison of the sensation of saltiness between the two treatment groups [Time Frame: 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 Outcome(s)

Comparison of Delta FEV1 between the two treatment groups [Time Frame: day 1 and day 28 of the four-weeks treatment]

Secondary ID(s)

HS/2009 HYANEB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors