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

NCT01658449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-08-10

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Inhalable Hypertonic saline 7% + Hyaluronan 0.1%

Administration of Inhalable Hypertonic saline 7% + Hyaluronan 0.1% 5 ml twice a day, after bronchodilator for one month.

OTHER

Inhalable Hypertonic saline 7%

Administration of Inhalable Hypertonic saline 7% 5 ml twice a day, after bronchodilator for one month.

Sponsors & Collaborators

  • Ospedale Civile Ca' Foncello

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01658449 on ClinicalTrials.gov