85. 特発性間質性肺炎
［臨床試験数：514，薬物数：377（DrugBank：108），標的遺伝子数：97，標的パスウェイ数：204］
Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
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.
| 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 | Not yet recruiting | 40 Years | 75 Years | All | 50 | Phase 1;Phase 2 | United States |
| 2 | NCT04312594 (ClinicalTrials.gov) | August 13, 2020 | 27/2/2020 | Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary Fibrosis | A Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Trial of Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets;Drug: Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets;Drug: Placebo oral tablet and Acetylcysteine Effervescent Tablets | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | NULL | Recruiting | 50 Years | N/A | All | 90 | Phase 2 | China |
| 3 | 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 |
| 4 | 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 | ||
| 5 | NCT02707640 (ClinicalTrials.gov) | August 2013 | 9/3/2016 | A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF) | 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 | Idiopathic Pulmonary Fibrosis | Drug: Matching Placebo;Drug: N-acetylcysteine;Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 123 | Phase 2 | Austria;Belgium;Denmark;France;Germany;Italy;Sweden;United Kingdom |
| 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 |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 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 |
| 11 | JPRN-UMIN000016706 | 2013/01/07 | 04/03/2015 | Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis | N-acetylcysteine was administered by inhalation at the dose of 352.4 mg b.i.d. via an ultrasonic nebulizer. | Saitama Red Cross Hospital | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 25 | Not selected | Japan | |
| 12 | 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 |
| 13 | 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). | Idiopathic pulmonary fibrosis | inhaled NAC mono-therapy | Toho University Omori Medical CenterDepartment of Respiratory Medicine | NULL | Recruiting | 50years-old | 80years-old | Male and Female | 50 | Not selected | Japan | |
| 14 | 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 |