299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05740618 (ClinicalTrials.gov) | March 1, 2023 | 3/2/2023 | Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis | Effect of Bronchitol on Mucociliary Clearance in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Modulator Treated Patients With Cystic Fibrosis With Moderate to Severe Lung Disease | Cystic Fibrosis | Drug: Mannitol Inhalant Product | University of North Carolina, Chapel Hill | Chiesi USA, Inc. | Not yet recruiting | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 2 | EUCTR2013-005357-79-SE (EUCTR) | 01/06/2016 | 02/04/2016 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United 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 | ||
| 3 | EUCTR2013-005357-79-BG (EUCTR) | 12/02/2016 | 11/01/2016 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United 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 | ||
| 4 | EUCTR2013-005357-79-GR (EUCTR) | 02/02/2016 | 17/12/2015 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United 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 | ||
| 5 | EUCTR2013-005357-79-IT (EUCTR) | 18/11/2014 | 06/06/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Sweden | ||
| 6 | EUCTR2013-005357-79-HU (EUCTR) | 13/11/2014 | 06/06/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United 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 | ||
| 7 | EUCTR2013-005357-79-CZ (EUCTR) | 15/10/2014 | 04/06/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United 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 | ||
| 8 | EUCTR2013-005357-79-SK (EUCTR) | 11/09/2014 | 26/08/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long 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 LTD | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Sweden | ||
| 9 | NCT02134353 (ClinicalTrials.gov) | September 2014 | 16/4/2014 | A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: Inhaled mannitol;Drug: Placebo Comparator: Arm B - Control | Pharmaxis | NULL | Completed | 18 Years | 99 Years | All | 423 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Czechia;Hungary;Israel;Italy;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;France |
| 10 | EUCTR2013-005357-79-BE (EUCTR) | 20/08/2014 | 01/07/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United 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 | ||
| 11 | EUCTR2012-002699-14-IT (EUCTR) | 28/05/2014 | 20/02/2014 | Trial of inhaled mannitol in children with cystic fibrosis | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Canada;Argentina;Belgium;Netherlands;United Kingdom;Italy | |||
| 12 | EUCTR2012-002699-14-NL (EUCTR) | 10/03/2014 | 02/10/2013 | Trial of inhaled mannitol in children with cystic fibrosis | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Argentina;France;Canada;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 13 | EUCTR2012-002699-14-BE (EUCTR) | 18/06/2013 | 15/02/2013 | Trial of inhaled mannitol in children with cystic fibrosis | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 160 | France;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom;Switzerland | |||
| 14 | NCT01883531 (ClinicalTrials.gov) | June 2013 | 17/6/2013 | Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 Years | A 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 | Cystic Fibrosis | Drug: Inhaled Mannitol;Drug: Inhaled Placebo | Pharmaxis | NULL | Completed | 6 Years | 17 Years | Both | 95 | Phase 2 | United Kingdom |
| 15 | NCT01887197 (ClinicalTrials.gov) | June 2013 | 24/6/2013 | Repeatability and Response Study of Absorptive Clearance Scans | Repeatability and Response Study of Absorptive Clearance Scans | Cystic Fibrosis | Other: Absorptive clearance scan;Drug: inhaled hypertonic saline (7%);Drug: mannitol inhalation powder | Tim Corcoran | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | United States |
| 16 | EUCTR2012-002699-14-GB (EUCTR) | 28/01/2013 | 03/07/2012 | Trial of inhaled mannitol in children with cystic fibrosis | A 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] | Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A | Pharmaxis Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Canada;Argentina;Belgium;Netherlands;Italy;United Kingdom | ||
| 17 | EUCTR2008-002740-42-NL (EUCTR) | 10/08/2009 | 25/03/2009 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;Netherlands;Belgium;France | |||
| 18 | NCT01309178 (ClinicalTrials.gov) | May 2009 | 4/3/2011 | Anti-inflammatory Pulmonal Therapy of Cystic Fibrosis (CF) Patients With Amitriptyline and Placebo | Anti-inflammatory Pulmonal Therapy of CF Patients With Amitriptyline and Placebo - a Randomised, Double-blind, Placebo-controlled, Multicenter, Cohort - Study | Cystic Fibrosis;Pneumonia | Drug: Amitriptyline;Drug: Mannite | University Children’s Hospital Tuebingen | Universität Duisburg-Essen;University of Ulm | Recruiting | 14 Years | 65 Years | Both | 30 | Phase 2 | Germany |
| 19 | EUCTR2008-002740-42-FR (EUCTR) | 11/03/2009 | 12/03/2009 | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Belgium;Netherlands;Germany | ||
| 20 | EUCTR2008-002740-42-BE (EUCTR) | 13/02/2009 | 17/11/2008 | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;Netherlands;Belgium;France | |||
| 21 | EUCTR2008-008228-34-GB (EUCTR) | 28/01/2009 | 29/07/2010 | Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients | Determination 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 18 | United Kingdom | |||
| 22 | EUCTR2007-001412-23-GB (EUCTR) | 09/01/2009 | 19/02/2008 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 340 | United Kingdom;Ireland | |||
| 23 | NCT00792714 (ClinicalTrials.gov) | December 2008 | 16/11/2008 | Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients | Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Mannitol | Pharmaxis | NULL | Completed | 6 Years | N/A | Both | 18 | Phase 1 | Australia;United Kingdom |
| 24 | EUCTR2008-002740-42-DE (EUCTR) | 13/11/2008 | 31/07/2008 | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;Netherlands;Belgium;France | |||
| 25 | NCT00630812 (ClinicalTrials.gov) | September 2008 | 27/2/2008 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study | Cystic Fibrosis | Drug: inhaled mannitol;Drug: Placebo comparator | Pharmaxis | ethica Clinical Research Inc.;Europe: KasaConsult bvba, Hoegaarden, Belgium;Argentina: Resolution Latin America; Buenos Aires, Argentina | Completed | 6 Years | N/A | All | 318 | Phase 3 | United States;Argentina;Belgium;Canada;France;Germany;Netherlands |
| 26 | EUCTR2007-001412-23-IE (EUCTR) | 27/09/2007 | 11/07/2007 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Ireland | |||
| 27 | EUCTR2006-004078-28-GB (EUCTR) | 14/03/2007 | 15/02/2012 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United Kingdom | ||
| 28 | NCT00446680 (ClinicalTrials.gov) | March 2007 | 12/3/2007 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study | Cystic Fibrosis | Drug: Mannitol;Drug: placebo | Pharmaxis | NULL | Completed | 6 Years | N/A | Both | 340 | Phase 3 | Australia;Ireland;United Kingdom |
| 29 | NCT00117208 (ClinicalTrials.gov) | November 2005 | 30/6/2005 | Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis | A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: mannitol;Drug: mannitol + pulmozyme;Drug: Dornase alpha | Pharmaxis | NULL | Completed | 8 Years | 18 Years | Both | 20 | Phase 2 | United Kingdom |
| 30 | NCT00251056 (ClinicalTrials.gov) | October 2005 | 30/6/2005 | Mannitol Dose Response Study in Cystic Fibrosis | A 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 Fibrosis | Cystic Fibrosis | Drug: mannitol | Pharmaxis | NULL | Completed | 7 Years | N/A | Both | 48 | Phase 2 | Argentina;Canada |
| 31 | EUCTR2004-001888-21-GB (EUCTR) | 03/12/2004 | 22/02/2005 | A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis | A 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) | Product Name: DP Mannitol INN or Proposed INN: Mannitol Trade Name: Pulmozyme (dornase alfa) Product Name: Pulmozyme (dornase alfa) INN or Proposed INN: Dornase alfa Other descriptive name: rhDNAse | Pharmaxis Ltd | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 32 | NCT00455130 (ClinicalTrials.gov) | March 2004 | 2/4/2007 | A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis | Cystic Fibrosis | Drug: Inhaled mannitol | Pharmaxis | NULL | Completed | 8 Years | N/A | Both | Phase 2 | Australia;New Zealand | ||
| 33 | EUCTR2012-002699-14-FR (EUCTR) | 20/09/2012 | Trial of inhaled mannitol in children with cystic fibrosis | A 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] | Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A | Pharmaxis Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Canada;Argentina;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom | |||
| 34 | EUCTR2007-001412-23-DE (EUCTR) | 26/01/2009 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Long 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 340 | Phase 3 | Ireland;Germany;United Kingdom |