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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ospedale Civile Ca' Foncello
ClinicalTrials.gov Identifier:
NCT01658449
First received: July 13, 2012
Last updated: August 9, 2012
Last verified: February 2009
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Other: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%
Other: Inhalable Hypertonic saline 7%

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Ospedale Civile Ca' Foncello:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Comparison of Delta FEV1 between the two treatment groups [ Time Frame: day 1 and day 28 of the four-weeks treatment ] [ Designated as safety issue: No ]

    Secondary outcome was the effect on respiratory function. A sequence of spirometries was performed as follows. A spirometry was performed in basal conditions, then 400 ug of salbutamol were administered and spirometry was performed again after 15 minutes. Whitin 30 minutes, the first dose of the randomized formulation was administered for 15 minutes and a third spirometry was performed 30 minutes after the inhalation. This sequence was repeated 4 weeks later, with the administration of the last dose of treatment.

    Delta FEV1 was calculated as follows: [(FEV1 after randomized solution inhalation - FEV1 after bronchodilator)/FEV1 after bronchodilator]x 100. Delta FEV1 was the outcome measure used to compare the two groups of treatment both at the first dose of the four-weeks treatment and at the end (last dose)of the four-weeks treatment.



Enrollment: 40
Study Start Date: December 2009
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group A 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.
Experimental: group B Other: Inhalable Hypertonic saline 7%
Administration of Inhalable Hypertonic saline 7% 5 ml twice a day, after bronchodilator for one month.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 β2 bronchodilators;
  • Concurrent enrolment in other clinical trials;
  • Plasmatic creatinine and transaminases more than twice the normal values.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658449

Locations
Italy
centro Fibrosi Cistica
Treviso, Italy, 3100
Sponsors and Collaborators
Ospedale Civile Ca' Foncello
  More Information

No publications provided

Responsible Party: Ospedale Civile Ca' Foncello
ClinicalTrials.gov Identifier: NCT01658449     History of Changes
Other Study ID Numbers: HS/2009 HYANEB
Study First Received: July 13, 2012
Last Updated: August 9, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014