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

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ClinicalTrials.gov Identifier: NCT01658449
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : August 10, 2012
Sponsor:
Information provided by (Responsible Party):
Ospedale Civile Ca' Foncello

Tracking Information
First Submitted Date  ICMJE July 13, 2012
First Posted Date  ICMJE August 7, 2012
Last Update Posted Date August 10, 2012
Study Start Date  ICMJE December 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • 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.
  • Other: Inhalable Hypertonic saline 7%
    Administration of Inhalable Hypertonic saline 7% 5 ml twice a day, after bronchodilator for one month.
Study Arms  ICMJE
  • Experimental: group A
    Intervention: Other: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%
  • Experimental: group B
    Intervention: Other: Inhalable Hypertonic saline 7%
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2012)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01658449
Other Study ID Numbers  ICMJE HS/2009 HYANEB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ospedale Civile Ca' Foncello
Study Sponsor  ICMJE Ospedale Civile Ca' Foncello
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ospedale Civile Ca' Foncello
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP