Isotonic saline    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis16

299. Cystic fibrosis    [ 1,592 clinical trials,   1,539 drugs,   (DrugBank: 255 drugs),   81 drug target genes,   162 drug target pathways]
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
16 / 1,592 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-004143-39-IT
(EUCTR)
19/12/201820/09/2018Saline hypertonic in preschoolers and lung structure as measured by computed tomography.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 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;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]
Erasmus MCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy
2EUCTR2015-004143-39-ES
(EUCTR)
19/04/201731/03/2017Saline hypertonic in preschoolers and lung structure as measured by computed tomography.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 Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.1;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]
Product Name: Hypertonic saline
INN or Proposed INN: HYPERTONIC SALINE
Other descriptive name: SALINE
Product Name: Isotonic saline
INN or Proposed INN: ISOTONIC SALINE
Other descriptive name: STERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V)
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Denmark;Australia;Netherlands
3EUCTR2015-004143-39-DK
(EUCTR)
14/02/201725/10/2016Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study.A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study 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]
Product Name: Hypertonic saline
INN or Proposed INN: sodium chloride 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline 0.9%
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Australia;Denmark;Netherlands
4NCT02947126
(ClinicalTrials.gov)
January 201725/10/2016Multilevel Models of Therapeutic Response in the LungsMultilevel Models of Therapeutic Response in the LungsCystic FibrosisDrug: Hypertonic Saline;Drug: Isotonic Saline;Drug: Indium-DTPA;Drug: Technetium Sulfur ColloidTim CorcoranNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting12 YearsN/AAll62Phase 1United States
5EUCTR2015-004143-39-BE
(EUCTR)
30/11/201613/10/2016Saline hypertonic in preschoolers and lung structure as measured by computed tomography.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 Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;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]
Product Name: Hypertonic saline
INN or Proposed INN: SODIUM CHLORIDE 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Belgium;Denmark;Australia;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-004143-39-NL
(EUCTR)
09/08/201621/12/2015Saline hypertonic in preschoolers and lung structure as measured by computed tomography.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 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;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]
Product Name: Hypertonic saline
INN or Proposed INN: SODIUM CHLORIDE 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Belgium;Denmark;Australia;Netherlands
7NCT02950883
(ClinicalTrials.gov)
August 201627/10/2016Saline Hypertonic in Preschoolers + CTSaline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)Cystic FibrosisDrug: Active Treatment Group 7% Hypertonic Saline;Drug: Control Group 0.9% Isotonic SalineUniversity of Washington, the Collaborative Health Studies Coordinating CenterCystic Fibrosis FoundationActive, not recruiting3 Years5 YearsAll116Phase 2;Phase 3United States;Australia;Belgium;Canada;Denmark;France;Italy;Netherlands;Spain
8NCT02378467
(ClinicalTrials.gov)
March 1, 201527/2/2015Saline Hypertonic in PreschoolersSaline Hypertonic in PreschoolersCystic FibrosisDrug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS)University of Washington, the Collaborative Health Studies Coordinating CenterCystic Fibrosis FoundationCompleted3 Years5 YearsAll150N/AUnited States;Canada
9NCT01619657
(ClinicalTrials.gov)
June 201212/6/2012Preventive Inhalation of Hypertonic Saline in Infants With Cystic FibrosisRandomized, Double-blind, Controlled Pilot Study on Safety of Hypertonic Saline as Preventive Inhalation Therapy in Newborns and Infants With Cystic FibrosisCystic Fibrosis Lung DiseaseDrug: 6% Hypertonic Saline (HS), 4mL;Drug: 0.9% Isotonic Saline (IS), 4mLHeidelberg UniversityGerman Center for Lung ResearchCompletedN/A4 MonthsAll42Phase 2Germany
10NCT02276898
(ClinicalTrials.gov)
November 201122/10/2014A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance IndexA Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index as a Short-term Pharmacodynamic Biomarker in Patients With Cystic Fibrosis.Cystic FibrosisDrug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo)The Hospital for Sick ChildrenNULLCompleted6 Years18 YearsBoth24Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01223183
(ClinicalTrials.gov)
September 201014/10/2010Absorptive Clearance After Inhaled Osmotics in Cystic FibrosisAbsorptive Clearance After Inhaled Osmotics in Cystic FibrosisCystic FibrosisDrug: hypertonic saline (7%);Drug: isotonic salineUniversity of PittsburghNULLCompleted18 YearsN/AAll20Phase 1United States
12NCT00709280
(ClinicalTrials.gov)
April 20091/7/2008Infant Study of Inhaled Saline in Cystic FibrosisInfant Study of Inhaled Saline in Cystic FibrosisCystic FibrosisDrug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS)CF Therapeutics Development Network Coordinating CenterCystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI)Completed4 Months59 MonthsBoth321N/AUnited States;Canada
13NCT00635141
(ClinicalTrials.gov)
March 20084/3/2008The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic FibrosisThe Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic FibrosisCystic FibrosisDrug: hypertonic saline (7 %) and isotonic saline (0.9%)The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationCompleted6 Years18 YearsBoth20Phase 3Canada
14NCT00628134
(ClinicalTrials.gov)
March 200822/2/2008Self-dispersing Liquids as Aerosol Drug CarriersSelf-dispersing Liquids as Aerosol Drug CarriersCystic FibrosisDrug: calfactant;Drug: isotonic salineUniversity of PittsburghCystic Fibrosis Foundation TherapeuticsCompleted18 YearsN/AAll8N/AUnited States
15NCT00534079
(ClinicalTrials.gov)
September 200721/9/2007Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic RhinosinusitisNasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical StudyCystic Fibrosis;RhinosinusitisDrug: Dornase alfa (Pulmozyme);Drug: isotonic salineUniversity of JenaNULLCompleted5 YearsN/ABoth23Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-004143-39-FR
(EUCTR)
30/03/2017Saline hypertonic in preschoolers and lung structure as measured by computed tomography.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 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;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]
Erasmus MCNULLNA Female: yes
Male: yes
120Phase 3United States;France;Spain;Belgium;Denmark;Australia;Netherlands;Italy