229. 肺胞蛋白症(自己免疫性又は先天性) Autoimmune pulmonary alveolar proteinosis Clinical trials / Disease details


臨床試験数 : 43 薬物数 : 34 - (DrugBank : 8) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 14

  
25 trials found
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1EUCTR2020-001263-85-NL
(EUCTR)
19/07/202108/10/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution byinhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Netherlands;Germany;Japan;Korea, Republic of
2NCT04544293
(ClinicalTrials.gov)
May 10, 20213/9/2020Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)A Randomized, Double-blind, Placebo-controlled Clinical Trial of Once-daily Inhaled Molgramostim Nebulizer Solution in Adult Subjects With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)Autoimmune Pulmonary Alveolar ProteinosisDrug: Molgramostim;Drug: PlaceboSavara Inc.NULLRecruiting18 YearsN/AAll160Phase 3United States;Australia;Belgium;Canada;France;Germany;Greece;Ireland;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Turkey;United Kingdom
3EUCTR2020-001263-85-BE
(EUCTR)
08/03/202104/12/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution byinhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
4EUCTR2020-001263-85-IE
(EUCTR)
08/02/202108/10/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Ireland;Turkey;Italy;United Kingdom;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
5EUCTR2020-001263-85-DE
(EUCTR)
27/01/202116/10/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Ireland;Turkey;Italy;United Kingdom;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
6EUCTR2020-001263-85-PL
(EUCTR)
16/12/202019/11/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Canada;Poland;Belgium;Romania;Germany;Netherlands;Japan;Korea, Republic of;France;Italy;United Kingdom;Turkey;Ireland;United States
7EUCTR2020-001263-85-IT
(EUCTR)
18/11/202024/05/2021A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP) - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 µg nebulizer solution
Product Code: [na]
INN or Proposed INN: 00201600
SAVARA APSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Korea, Democratic People's Republic of;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
8EUCTR2017-004078-32-IT
(EUCTR)
16/05/201907/01/2019Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalationAN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Netherlands;France;Greece;Denmark;Russian Federation;Israel;Germany;United Kingdom;Italy
9EUCTR2017-004078-32-GB
(EUCTR)
05/06/201801/02/2018Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalationAN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom
10EUCTR2017-004078-32-GR
(EUCTR)
05/06/201810/05/2018Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalationAN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
11EUCTR2017-004078-32-DE
(EUCTR)
30/05/201818/12/2017Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalationAN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
12EUCTR2017-004078-32-NL
(EUCTR)
08/05/201818/12/2017Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalationAN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy
13NCT03482752
(ClinicalTrials.gov)
April 16, 201821/3/2018Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar ProteinosisAn Open-label, Non-controlled, Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis PatientsAutoimmune Pulmonary Alveolar ProteinosisDrug: MolgramostimSavara Inc.NULLCompleted18 YearsN/AAll62Phase 3Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Russian Federation;Turkey;United Kingdom
14EUCTR2017-004078-32-FR
(EUCTR)
22/03/201818/12/2017Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalationAN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;France;Greece
15EUCTR2015-003878-33-PT
(EUCTR)
16/02/201806/11/2017A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of;Greece;Spain;United States;Portugal;Slovakia
16EUCTR2017-004078-32-DK
(EUCTR)
06/02/201818/12/2017Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalationAN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
17EUCTR2015-003878-33-ES
(EUCTR)
22/10/201605/08/2016A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 19.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot Recruiting Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Denmark;Germany;Netherlands;Japan
18EUCTR2015-003878-33-IT
(EUCTR)
19/09/201630/08/2016A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 19.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
51Phase 2;Phase 3Portugal;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Denmark;Germany;Netherlands;Japan
19NCT02702180
(ClinicalTrials.gov)
May 9, 201628/2/2016Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients IMPALAAutoimmune Pulmonary Alveolar ProteinosisDrug: molgramostim;Drug: placeboSavara Inc.NULLCompleted18 Years75 YearsAll139Phase 2/Phase 3United States;Australia;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Turkey;United Kingdom;Poland;Romania
20EUCTR2015-003878-33-GR
(EUCTR)
05/04/201617/03/2016A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients IMPALA - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 18.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Serendex Pharmaceuticals A/SNULLNot Recruiting Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands;Japan
21EUCTR2015-003878-33-DE
(EUCTR)
22/02/201611/11/2015A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot Recruiting Female: yes
Male: yes
135 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
22EUCTR2015-003878-33-GB
(EUCTR)
28/01/201622/10/2015A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot Recruiting Female: yes
Male: yes
135 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Poland;Romania;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
23EUCTR2015-003878-33-NL
(EUCTR)
19/01/201628/10/2015A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000015560;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 2;Phase 3United States;Portugal;Slovakia;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of
24EUCTR2015-003878-33-DK
(EUCTR)
11/12/201523/10/2015A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000015560;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 2;Phase 3Slovakia;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of;United States;Portugal
25NCT02468908
(ClinicalTrials.gov)
May 20153/6/2015Inhaled Molgramostim (rhGM-CSF) in Healthy Adult SubjectsA Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Molgramostim When Administered by Inhalation to Healthy Adult SubjectsPulmonary Alveolar Proteinosis;Bronchiectasis;Cystic Fibrosis;Acute Respiratory Distress SyndromeDrug: Molgramostim;Drug: PlaceboSavara Inc.CelerionCompleted18 Years55 YearsAll42Phase 1United Kingdom