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van CCT (UK)


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van CCT (UK)


Saline hypertonic in preschoolers and lung structure as measured by computed tomography.


- candidate number22914
- NTR NumberNTR5502
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2015
- Secondary IDs2015-004143-39  EudraCT
- Public TitleSaline hypertonic in preschoolers and lung structure as measured by computed tomography.
- Scientific TitleA 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
- ACRONYMShip-CT study
- hypothesisThe primary hypothesis is that HS will reduce structural lung disease as assessed by the PRAGMA-CF computed tomography score relative to IS during the 48 week treatment period.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF)
- Inclusion criteria1. 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 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 execute a technician controlled or spirometer controlled chest CT scan
- Exclusion criteria1. Chest CT within 8 months prior to the Screening visit
2. 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 Enrollment visit
4. Oxygen saturation < 95% (<90% at centres above 4000 feet elevation) at Screening or Enrollment 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 hypertonic saline at any concentration within 30 days prior to Screening or Enrolment visit
9. 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
10. Chronic lung disease not related to CF
11. Inability to tolerate first dose of study treatment at the Enrolment visit
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate1-mei-2018
- Target number of participants120
- InterventionsTest drug, dose and mode of administration:
7% Hypertonic Saline (HS).
In Australia this will be supplied in 10mL glass vials packed 5 vials per pack in plain white packaging, and manufactured by Phebra.
In Europe this will be supplied in 5 ml glass ampoules, 7 vials per pack, and manufactured by Apotheek A15.
4ml of HS will be administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI compressor (PARI Vios Pro in USA, PARI BOY SX in Australia and Europe).

Control, dose and mode of administration:
0.9% Isotonic Saline (IS).
In Australia this will be supplied in 10mL glass vials packed 5 vials per pack in plain white packaging, and manufactured by Phebra.
In Europe this will be supplied in 5 ml glass ampoules, 7 vials per pack, and manufactured by Apotheek A15. The delivery system is the same as that for the test product. 4 ml of IS will be administered via inhalation twice daily for 48 weeks
- Primary outcomeThe difference in PRAGMA-CF %Dis between HS and IS study arm at end of study (48 weeks), measured from standardized chest CT.
- Secondary outcomeLongitudinal 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 and Airway dimensions as measured using the AA method from chest CT
on expiratory or spontaneous breathing CTs
Longitudinal change in LCI, measured by N2 MBW, from baseline to 48 weeks between treatment arms.
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).
- TimepointsN/A
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. H.A.W.M. Tiddens
- CONTACT for SCIENTIFIC QUERIESDr. H.A.W.M. Tiddens
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Cystic Fibrosis Foundation Therapeutics, Inc., Erasmus Medical Center
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD29-sep-2015 - 15-jan-2016


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