299. 嚢胞性線維症
[臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
33 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-005357-79-SE
(EUCTR)
01/06/201602/04/2016Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;New Zealand;Sweden
2EUCTR2013-005357-79-BG
(EUCTR)
12/02/201611/01/2016Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
3EUCTR2013-005357-79-GR
(EUCTR)
02/02/201617/12/2015Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
4EUCTR2013-005357-79-IT
(EUCTR)
18/11/201406/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 17.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Sweden
5EUCTR2013-005357-79-HU
(EUCTR)
13/11/201406/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-005357-79-CZ
(EUCTR)
15/10/201404/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 19.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
7EUCTR2013-005357-79-SK
(EUCTR)
11/09/201426/08/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
PHARMAXIS LTDNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Sweden
8NCT02134353
(ClinicalTrials.gov)
September 201416/4/2014A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsCystic FibrosisDrug: Inhaled mannitol;Drug: Placebo Comparator: Arm B - ControlPharmaxisNULLCompleted18 Years99 YearsAll423Phase 3United States;Argentina;Australia;Belgium;Canada;Czechia;Hungary;Israel;Italy;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;France
9EUCTR2013-005357-79-BE
(EUCTR)
20/08/201401/07/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
10EUCTR2012-002699-14-IT
(EUCTR)
28/05/201420/02/2014Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Canada;Argentina;Belgium;Netherlands;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-002699-14-NL
(EUCTR)
10/03/201402/10/2013Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Argentina;France;Canada;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
12EUCTR2012-002699-14-BE
(EUCTR)
18/06/201315/02/2013Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160France;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom;Switzerland
13NCT01887197
(ClinicalTrials.gov)
June 201324/6/2013Repeatability and Response Study of Absorptive Clearance ScansRepeatability and Response Study of Absorptive Clearance ScansCystic FibrosisOther: Absorptive clearance scan;Drug: inhaled hypertonic saline (7%);Drug: mannitol inhalation powderTim CorcoranNULLCompleted18 YearsN/AAll24Phase 1United States
14NCT01883531
(ClinicalTrials.gov)
June 201317/6/2013Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 YearsA Randomised, Multicentre, Double-blind, Placebo-controlled, Crossover Trial Determining the Efficacy of Dry Powder Mannitol in Improving Lung Function in Subjects With Cystic Fibrosis Aged Six to Seventeen YearsCystic FibrosisDrug: Inhaled Mannitol;Drug: Inhaled PlaceboPharmaxisNULLCompleted6 Years17 YearsBoth95Phase 2United Kingdom
15EUCTR2012-002699-14-GB
(EUCTR)
28/01/201303/07/2012Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Pharmaxis Ltd.NULLNot Recruiting Female: yes
Male: yes
160Phase 2France;Canada;Argentina;Belgium;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2008-002740-42-NL
(EUCTR)
10/08/200925/03/2009Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
17NCT01309178
(ClinicalTrials.gov)
May 20094/3/2011Anti-inflammatory Pulmonal Therapy of Cystic Fibrosis (CF) Patients With Amitriptyline and PlaceboAnti-inflammatory Pulmonal Therapy of CF Patients With Amitriptyline and Placebo - a Randomised, Double-blind, Placebo-controlled, Multicenter, Cohort - StudyCystic Fibrosis;PneumoniaDrug: Amitriptyline;Drug: ManniteUniversity Children’s Hospital TuebingenUniversität Duisburg-Essen;University of UlmRecruiting14 Years65 YearsBoth30Phase 2Germany
18EUCTR2008-002740-42-FR
(EUCTR)
11/03/200912/03/2009Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
19EUCTR2008-002740-42-BE
(EUCTR)
13/02/200917/11/2008Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
20EUCTR2008-008228-34-GB
(EUCTR)
28/01/200929/07/2010Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patientsDetermination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients Cystic Fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: IDPM: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: MANNITOL
Pharmaxis LtdNULLNot RecruitingFemale: yes
Male: yes
18United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2007-001412-23-GB
(EUCTR)
09/01/200919/02/2008Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: IDPM: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: MANNITOL
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
340United Kingdom;Ireland
22NCT00792714
(ClinicalTrials.gov)
December 200816/11/2008Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis PatientsDetermination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis PatientsCystic FibrosisDrug: MannitolPharmaxisNULLCompleted6 YearsN/ABoth18Phase 1Australia;United Kingdom
23EUCTR2008-002740-42-DE
(EUCTR)
13/11/200831/07/2008Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
24NCT00630812
(ClinicalTrials.gov)
September 200827/2/2008Long Term Administration of Inhaled Mannitol in Cystic FibrosisLong Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy StudyCystic FibrosisDrug: inhaled mannitol;Drug: Placebo comparatorPharmaxisethica Clinical Research Inc.;Europe: KasaConsult bvba, Hoegaarden, Belgium;Argentina: Resolution Latin America; Buenos Aires, ArgentinaCompleted6 YearsN/AAll318Phase 3United States;Argentina;Belgium;Canada;France;Germany;Netherlands
25EUCTR2007-001412-23-IE
(EUCTR)
27/09/200711/07/2007Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-004078-28-GB
(EUCTR)
14/03/200715/02/2012Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: IDPM: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: MANNITOL
Pharmaxis UK LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United Kingdom
27NCT00446680
(ClinicalTrials.gov)
March 200712/3/2007Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy StudyCystic FibrosisDrug: Mannitol;Drug: placeboPharmaxisNULLCompleted6 YearsN/ABoth340Phase 3Australia;Ireland;United Kingdom
28NCT00117208
(ClinicalTrials.gov)
November 200530/6/2005Comparison of Inhaled Mannitol and rhDNase in Children With Cystic FibrosisA Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic FibrosisCystic FibrosisDrug: mannitol;Drug: mannitol + pulmozyme;Drug: Dornase alphaPharmaxisNULLCompleted8 Years18 YearsBoth20Phase 2United Kingdom
29NCT00251056
(ClinicalTrials.gov)
October 200530/6/2005Mannitol Dose Response Study in Cystic FibrosisA Phase IIa Randomised, Open Label, Dose Response Study to Determine the Optimum Dose of Dry Powder Mannitol Required to Generate Clinical Improvement In Patients With Cystic FibrosisCystic FibrosisDrug: mannitolPharmaxisNULLCompleted7 YearsN/ABoth48Phase 2Argentina;Canada
30EUCTR2004-001888-21-GB
(EUCTR)
03/12/200422/02/2005A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic FibrosisA cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis Cystic fibrosis (CF)Pharmaxis LtdNULLNot Recruiting Female: yes
Male: yes
42Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00455130
(ClinicalTrials.gov)
March 20042/4/2007A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic FibrosisCystic FibrosisDrug: Inhaled mannitolPharmaxisNULLCompleted8 YearsN/ABothPhase 2Australia;New Zealand
32EUCTR2007-001412-23-DE
(EUCTR)
26/01/2009Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Trade Name: Aridol or Osmohale
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
340Phase 3Ireland;Germany;United Kingdom
33EUCTR2012-002699-14-FR
(EUCTR)
20/09/2012Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 15.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Pharmaxis Ltd.NULLNot Recruiting Female: yes
Male: yes
160Phase 2France;Canada;Argentina;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom