---
title: Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients
nct_id: NCT01658449
overall_status: COMPLETED
phase: NA
sponsor: "Ospedale Civile Ca' Foncello"
study_type: INTERVENTIONAL
primary_condition: Cystic Fibrosis
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01658449.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01658449"
ct_last_update_post_date: 2012-08-10
last_seen_at: "2026-05-12T06:43:30.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients

**NCT ID:** [NCT01658449](https://clinicaltrials.gov/study/NCT01658449)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Ospedale Civile Ca' Foncello
- **Conditions:** Cystic Fibrosis
- **Start Date:** 2009-12
- **Completion Date:** 2011-09
- **CT.gov Last Update:** 2012-08-10

## 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

- **Minimum age:** 8 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **group A** (EXPERIMENTAL)
- **group B** (EXPERIMENTAL)

## Interventions

- **Inhalable Hypertonic saline 7% + Hyaluronan 0.1%** (OTHER) — Administration of Inhalable Hypertonic saline 7% + Hyaluronan 0.1% 5 ml twice a day, after bronchodilator for one month.
- **Inhalable Hypertonic saline 7%** (OTHER) — Administration of Inhalable Hypertonic saline 7% 5 ml twice a day, after bronchodilator for one month.

## Primary Outcomes

- **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.)_ — A judgment on acceptability and global pleasure of the inhalation was weekly reported by patients on a diary, expressed on a 1-10 scale: a score lower than 6 was considered unfavourable.
- **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.)_ — A judgement on the symptom cough, one of the most important causes of HS intolerance and poor compliance to HS treatment, was weekly reported by patients on a diary, as assessed on a scale of four grades (absent, mild, moderate, severe).
- **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.)_ — A judgement on the sensation of saltiness, one of the most important causes of HS intolerance and poor compliance to HS treatment, was weekly reported by patients on a diary, as assessed on a scale of four grades (absent, mild, moderate, severe).
- **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.)_ — A judgement on the sensation of throat irritation, one of the most important causes of HS intolerance and poor compliance to HS treatment, was weekly reported by patients on a diary, as assessed on a scale of four grades (absent, mild, moderate, severe).

## Secondary Outcomes

- **Comparison of Delta FEV1 between the two treatment groups** _(time frame: day 1 and day 28 of the four-weeks treatment)_

## Locations (1)

- centro Fibrosi Cistica, Treviso, Italy, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centro fibrosi cistica|treviso|italy|italy` — added _(2026-05-12)_

---

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