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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 23 October 2017
Main ID:  EUCTR2015-004143-39-NL
Date of registration: 21/12/2015
Prospective Registration: Yes
Primary sponsor: Erasmus MC
Public title: Saline hypertonic in preschoolers and lung structure as measured by computed tomography.
Scientific title: A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study
Date of first enrolment: 09/08/2016
Target sample size: 120
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004143-39
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Australia Belgium Denmark Netherlands Spain United States
Contacts
Name: Program manager   
Address:  Wytemaweg 80, room Sb-2672 3015 CN Rotterdam Netherlands
Telephone: 0031010703668
Email: shipCTstudy@erasmusmc.nl
Affiliation:  Erasmus MC
Name: Program manager   
Address:  Wytemaweg 80, room Sb-2672 3015 CN Rotterdam Netherlands
Telephone: 0031010703668
Email: shipCTstudy@erasmusmc.nl
Affiliation:  Erasmus MC
Key inclusion & exclusion criteria
Inclusion criteria:
Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria: a) A documented sweat chloride = 60 mEq/L by quantitative pilocarpineiontophoresis (QPIT) b) A documented genotype with two disease-causing mutations in the CFTR gene
Informed consent by parent or legal guardian
Age = 36 months and =72 months at Screening visit
Ability to comply with medication use, study visits and study procedures as judged by the site investigator
***Ability to execute a technician controlled or spirometer controlled chest CT scan***????

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Chest CT within 8 months prior to the Screening visit
Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding Screening or Enrolment visit
Acute wheezing at Screening or Enrollment visit
Oxygen saturation < 95% (<90% at centres above 4000 feet elevation) at Screening or Enrollment visit
Other major organ dysfunction, excluding pancreatic dysfunction
Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
Investigational drug use within 30 days prior to Screening or Enrolment visit
Treatment with inhaled hypertonic saline at any concentration within 30 days prior to Screening or Enrolment visit
Start of any additional inhaled saline solution at any concentration, or other hydrating agent such as mannitol or mucolytic drug such as dornase alpha within 30 days prior or following the Screening or Enrollment visit
Chronic lung disease not related to CF
Inability to tolerate first dose of study treatment at the Enrolment visit



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011763 Term: Cystic fibrosis lung System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Intervention(s)

Product Name: Hypertonic saline
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: SODIUM CHLORIDE 7%
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE 7%
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 70-

Product Name: Isotonic saline
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 9-

Primary Outcome(s)
Main Objective: Compare the difference in PRAGMA-CF total percent disease (%Dis) between HS and IS study arm at end of study (48 weeks), measured from standardized chest CT.
Primary end point(s): The difference in PRAGMA-CF total percent disease (%Dis) between HS and IS study arm at end of study (48 weeks), measured from standardized chest CT.
Secondary Objective: Compare the differences in PRAGMA-CF subscores: the volume proportions of the lung with bronchiectasis (%Bx) and trapped air (%TA), as well as airway dimensions as measured using the AA method measured from chest CT images at 48 weeks between treatment arms.
Elucidate the longitudinal relationships between measures of structural lung disease evaluated by chest CT (PRAGMA-CF (%Dis, %Bx, %TA) and AA method (AA ratio and airway dimensions), LCI measured by multiple breath washout and clinical outcomes (pulmonary exacerbations, health-related quality of life) over the 48-week treatment period.
Timepoint(s) of evaluation of this end point: During the whole study
Secondary Outcome(s)
Secondary end point(s): longitudinal change in airway disease (%Dis), bronchiectasis (%Bx) and trapped air (%TA), as well as the proportion of patients with bronchiectasis progression, from baseline to end of study as established by PRAGMA-CF on expiratory or spontaneous breathing CTs
Compare the change in LCI, measured by N2 MBW, from baseline to 48 weeks between treatment arms.
longitudinal change in LCI as measured by nitrogen washout
protocol-defined pulmonary exacerbation rate
modified parent-reported CFQ-R for preschool children, a CF-specific measure of health related quality of life (excluding European sites).
Timepoint(s) of evaluation of this end point: During the whole study
Secondary ID(s)
ISRCTN13083896
SHIP002
Source(s) of Monetary Support
Cystic Fibrosis Foundation Therapeutics (CFFT)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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