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

NCT01658449 | Completed

• 1 other identifier: HS/2009 HYANEB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• Comparison of the judgement on global pleasure of the inhalation between the two treatment 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.

  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

  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).

  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

  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).

  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

  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).

  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 (1)

• Comparison of Delta FEV1 between the two treatment groups

  day 1 and day 28 of the four-weeks treatment

Study Arms (2)

group A

EXPERIMENTAL

Other: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%

group B

EXPERIMENTAL

Other: Inhalable Hypertonic saline 7%

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.

group A

Inhalable Hypertonic saline 7% OTHER

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

group B

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale Civile Ca' Foncello: lead

Study Sites (1)

centro Fibrosi Cistica

Treviso, Italy, 3100, Italy

Location

Related Publications (1)

• 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.

  PMID: 23745525 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: August 7, 2012
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 10, 2012

Record last verified: 2009-02

Locations

IT (1)