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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: 13 March 2017
Main ID:  EUCTR2015-004143-39-DK
Date of registration: 25/10/2016
Prospective Registration: Yes
Primary sponsor: Erasmus MC
Public title: Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure as measured by computed tomography (CT). SHIP-CT study.
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: 14/02/2017
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 Denmark Netherlands United States
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Diagnosis of CF as evidenced by one or more clinical features
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
pilocarpine iontophoresis (QPIT)
b) A documented genotype with two disease-causing
mutations in the CFTR gene
2. Informed consent by parent or legal guardian
3. Age = 36 months and =72 months at screening visit
4. Ability to comply with medication use, study visits and study
procedures as judged by the site investigator
5. Ability to cooperate with chest CT at the enrolment visit as
determined by the lung function technician
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:
Acute intercurrent respiratory infection, defined as an increase in
cough, wheezing, or respiratory rate with onset within 3 weeks
preceding screening or enrolment visit
3. Acute wheezing at screening or enrolment visit
4. Oxygen saturation < 95% (<90% in centres located above 4000 feet
elevation) at screening or enrolment visit
5. Other major organ dysfunction, excluding pancreatic dysfunction
6. Physical findings that would compromise the safety of the
participant or the quality of the study data as determined by site
investigator
7. Investigational drug use within 30 days prior to screening or
enrolment visit
8. Treatment with inhaled HS at any concentration within 30 days prior
Chest CT within 8 months prior to screening or enrolment visit
9. Initiation (i.e. new prescription) of any inhaled hydrating agent such
as mannitol or mucolytic agents such as dornase alpha within 30
days prior to the screening or enrolment visit
10. Chronic lung disease not related to CF
11. 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: 19.1 Level: PT Classification code 10011763 Term: Cystic fibrosis lung 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
Current Sponsor code: sodium chloride 7%
Other descriptive name: SODIUM CHLORIDE 7%
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 70-

Product Name: Isotonic saline 0.9%
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 PRAGMA-CF total percent disease (%Dis) score (the
volume
proportion of the lung with structural airways disease) measured from
standardized chest CT at 48 weeks between treatment arms
Primary end point(s): The difference in PRAGMA-CF %Dis between HS and IS study arm at end
of
study (48 weeks), adjusted for baseline, measured from standardized
chest
CT.
Secondary Objective: Compare the PRAGMA-CF sub-scores %Bx (the volume proportion of the
lung with bronchiectasis) and %TA (the volume proportion of the lung
with trapped air), as well as airway-to-artery ratios (AA ratios)
measured
from chest CT images at 48 weeks between treatment arms
3. Compare the change in LCI, measured by N2 MBW, from baseline to 48
weeks between treatment arms.
4. Elucidate the cross-sectional and 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): i)The difference in PRAGMA-CF sub-scores, %Dx and %TA, between the
baseline CT and the 48 week CT.
ii) The absolute number of airways, airway dimensions and AA ratios
from TLC CTs, acquired at the 48-week visit.
2. The difference in LCI, measured by N2 MBW, from baseline to 48
weeks
3. Cross-sectional and longitudinal relationships between primary and
secondary PRAGMA-CF outcomes (%Dis, %Bx and %TA) and MBW
outcomes (LCI), airway dimensions and PRAGMA-CF and MBW
outcomes, as well as CFQ-R scores and PRAGMA-CF and MBW
outcomes.
Timepoint(s) of evaluation of this end point: During the whole study.
Secondary ID(s)
2015-004143-39-NL
SHIP002
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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