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Completed

NCT Number: NCT01658449

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

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.

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Key information

Conditions

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

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

centro Fibrosi Cistica

Treviso, Italy, 3100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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.

  2. 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).

  3. 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).

  4. 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

  1. Comparison of Delta FEV1 between the two treatment groups

    Time frame: day 1 and day 28 of the four-weeks treatment

    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.

Sponsors and collaborators

Lead sponsor

Ospedale Civile Ca' Foncello

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 7, 2012
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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