85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| 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 | NCT03720483 (ClinicalTrials.gov) | January 2022 | 18/7/2018 | Inhaled NAC in Treatment of IPF | Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) | Drug: N-acetyl cysteine then Placebo;Drug: Placebo then N-acetyl cysteine | University of Colorado, Denver | NULL | Withdrawn | 40 Years | 75 Years | All | 0 | Phase 1/Phase 2 | United States |
| 2 | NCT04300920 (ClinicalTrials.gov) | December 17, 2020 | 6/3/2020 | Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial | Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial | Idiopathic Pulmonary Fibrosis | Drug: N-acetyl cysteine;Drug: Placebo | Weill Medical College of Cornell University | University of Virginia;University of Michigan;Pulmonary Fibrosis Foundation;University of Washington;National Heart, Lung, and Blood Institute (NHLBI);Three Lakes Foundation | Recruiting | 40 Years | N/A | All | 200 | Phase 3 | United States |
| 3 | ChiCTR2000031386 | 2020-04-01 | 2020-03-29 | The impact of NAC treatment in IPF patients in mainland China: a retrospective study | The impact of NAC treatment in IPF patients in mainland China: a retrospective study | idiopathic pulmonary fibrosis | Study group:acetylcysteine 0.6 tid po.;control group:did not take NAC or other antifibrotic drugs; | Shanghai Pulmonary Hospital, Tongji University School of Medicine | NULL | Recruiting | Both | Study group:348;control group:174; | China | |||
| 4 | JPRN-UMIN000015508 | 2015/01/01 | 24/10/2014 | A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis | Using Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks. Pirfenidone 1200-1800mg (control group) | Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan. | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 150 | Not selected | Japan |
| 5 | NCT02055456 (ClinicalTrials.gov) | February 2014 | 3/2/2014 | Nandrolone Decanoate in the Treatment of Telomeropathies | Male Hormones for Telomere Related Diseases | Aplastic Anemia;Bone Marrow Failure Syndromes;Idiopathic Pulmonary Fibrosis;Telomere Shortening | Drug: Nandrolone Decanoate | University of Sao Paulo | Conselho Nacional de Desenvolvimento Científico e Tecnológico | Recruiting | 2 Years | N/A | Both | 20 | Phase 1/Phase 2 | Brazil |
| 6 | EUCTR2012-000564-14-GB (EUCTR) | 11/09/2013 | 04/07/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 7 | EUCTR2012-000564-14-DK (EUCTR) | 28/08/2013 | 12/07/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 8 | EUCTR2012-000564-14-AT (EUCTR) | 19/07/2013 | 11/06/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 9 | EUCTR2012-000564-14-DE (EUCTR) | 17/07/2013 | 29/05/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 10 | EUCTR2012-000564-14-IT (EUCTR) | 17/07/2013 | 07/06/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 11 | EUCTR2012-000564-14-SE (EUCTR) | 25/06/2013 | 24/05/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 12 | EUCTR2012-000564-14-BE (EUCTR) | 18/06/2013 | 30/04/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 13 | JPRN-UMIN000016045 | 2009/10/03 | 26/12/2014 | A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis | Using Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks. Pirfenidone 1200-1800mg (control group) | Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo | ,NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 14 | JPRN-UMIN000007663 | 2009/06/01 | 05/04/2012 | Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF). | Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF). - Efficacy of inhaled NAC in IPF. | Idiopathic pulmonary fibrosis | inhaled NAC mono-therapy | Toho University Omori Medical CenterDepartment of Respiratory Medicine | NULL | Complete: follow-up complete | 50years-old | 80years-old | Male and Female | 50 | Not selected | Japan |
| 15 | NCT00639496 (ClinicalTrials.gov) | March 2000 | 13/3/2008 | Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF) | Pulmonary Fibrosis | Drug: n-acetylcysteine;Drug: placebo | Zambon SpA | NULL | Completed | 18 Years | 75 Years | Both | 184 | Phase 3 | Belgium;France;Germany;Italy;Netherlands;Spain;United Kingdom |