Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Comparison of the judgement on global pleasure of the inhalation between the two treatment groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
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(day 1 and day 28 of the four-weeks treatment)