DDrare: Database of Drug Development for Rare Diseases

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.

Drug = (18)F-FDG; 18F-FDG; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; 534-1508; 68Ga-BMV101; ACETYLCYSTEINE; ACT-064992; ACT-064992 (macitentan); ART-123; AZAPRED; Acetate; Acetylcysteine; Acetylcysteine Effervescent Tablets; Adult human mesenchymal stem cells; Aerosol interferon-gamma; Air; Alemtuzumab; Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs); Ambrisentan; Antimicrobial therapy: Co-trimoxazole or Doxycycline; Atezolizumab; Autoantibody Reductive Therapy; Autologous Adipose Derived MSCs (ADMSCs); Autologous Stromal Vascular Fraction (SVF); Autologous mesenchymal stem cells derived from bone marrow; Aviptadil; Aviptadil, 66 microgram/mL; Azathioprine; Azathioprine/prednisone; Azithromycin; BBT-877, Multiple doses; BBT-877, Single dose; BG00011; BI 1015550; BIBF 1120; BIBF 1120 ES; BIBF1120; BLD-2660; BMS-986020; BMS-986278; BOSENTAN; Bardoxolone; Bardoxolone methyl; Beclometasone dipropionate; Bevacizumab; Blood sample collection; Bone marrow mesenchymal stem cells; Bosentan; C21; CBDCA; CC; CC-90001; CC-930; CD3/CD19 negative hematopoietic stem cells; CNC; CNTO 888 1 mg/kg; CNTO 888 15 mg/kg; CNTO 888 5 mg/kg; CNTO888; CO; CO-TRIMOXAZOLE; COMPOUND 21; Carbon; Carbon monoxide; Carboplatin; Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03); Co-trimoxazole; Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids; Corticosteroid (prednisolone); Cotrimoxazole; Cravit; Cromoglicate; Cromoglicato disodico; Cromoglycate; Cromolyn; Cromolyn Sodium; Cromolyn sodio (cromoglicato disodico, DSCG); Cromolyn sodium [Disodium Cromoglycate]; Cyclophosphamide; Cyclosphamine; Cysteine; DEX284; DPA; Dabigatran; Dasatinib; Dasatinib + Quercetin; Device: Auto-titrating oxygen system; Device: Centricyte 1000; Device: MRI; Device: Oxymizer® compared to CNC; Dextromethorphan; Diagnostic Test: Metabolomics; Diagnostic Test: PET Imaging; Disodium Cromoglycate [cromolyn sodium]; Disodium cromoglycate (DSCG); Doxycycline; EGCG; ENDOXAN; ESBRIET; EZ-2053; EZ-2053 5mg/kg; Endobronchial infusion of adult mesenchymal stem cells; Endoxan; Epigallocatechin; Epigallocatechin-3-gallate (EGCG); Erivedge; Esbriet; Esbriet® (Pirfenidon); Etanercept; Etoposide; FG-3019; FG-3019 10mg/mL in 10 mL vials; FLUORINE (18F) FLUDEOXYGLUCOSE; Fludarabine; Fludeoxyglucose; Fluimucil; Fluimucil® 600 mg effervescent tablets; Formoterol; Formoterol fumarate dihydrate; Fostair; G-CSF; G321605; G451990; GBT440; GBT440 300 mg capsule; GBT440 300 mg tablet; GC1008; GKT137831; GLPG1205; GLPG1690; GLPG1690 600 mg QD; GS-6624; GSK2126458; GSK3008348; GSK3008348 Nebuliser solution; Gallium68-Dota-Noc; Gefapixant; Granulocyte Colony Stimulating Factor; HEC 68498; HEC585; High dose BIBF 1120 twice daily; Humanized anti-alpha v beta 6 mAb; Hydroxyurea; Hyperoxia; Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment; Hyperpolarized 129-Xenon gas; IDL-2965 Oral Capsule; INO; INOmax; INOmax 400ppm mol/mol inhalation gas; IW001; Ifenprodil; Iloprost; Iloprost Inhalation Solution (Ventavis); Imatinib; Imatinib Mesylate (Gleevec); Immukin; Inhaled Nitric Oxide; Inhaled Nitric Oxide - 30 mcg/kg IBW/hr; Inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr; Inhaled TD139; Inhaled carbon monoxide; Inhaled nitric oxide 75 mcg/kg IBW/hr; Inomax; Interferon Gamma; Interferon alpha oral lozenge; Interferon gamma-1b; Interferon gamma-1b (Actimmune); Interferon-alpha lozenges; Interferon-gamma 1b; Intermediate dose BIBF 1120 twice daily; Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets; Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets; Jin-shui Huan-xian granule; KD025; L - Antineoplastic and immunomodulating agents; L01 - Antineoplastic agents; L01X - Other antineoplastic agents; L01XE - Protein kinase inhibitors; L01XE31; L01XE31 - Nintedanib; LANREOTIDE ACETATE; LEBRIKIZUMAB; LPA1; Lanreotide; Lansoprazole; Lebrikizumab; Letairis; Letairis 10 mg; Letairis 5 mg; Liberase Enzyme (Roche); Losartan; Low dose BIBF 1120 twice daily; Low dose BIBF1120 once daily; Lung Spheroid Stem Cells 100 million; Lung Spheroid Stem Cells 200 million; Lung stem cells; MACITENTAN; MESNA; MG-S-2525; MONITOR; Macitentan; Medical air; Medical air (sham O2); Mesna; Minocycline; Montelukast; Morphine; Morphine Sulfate; Morphine hydrochloride; Morphine sulfate; Moxifloxacin; Mycophenolate; Mycophenolate mofetil; N-Acetylcysteine, (NAC); N-acetyl cysteine; N-acetylcysteine; NAC; NALBUPHINE HYDROCHLORIDE; ND-L02-s0201; ND-L02-s0201 for injection; NINTEDANIB; NITRIC OXIDE; Na; Nalbuphine; Nalbuphine ER; Nalbuphine Extended-Realease (ER) Tablets; Nalbuphine Extended-Release (ER) Tablets; Nandrolone; Nandrolone Decanoate; Nandrolone decanoate; Nintedanib; Nitric Oxide; Nivolumab; None; OFEV®; ORIN1001; Octreotide; Ofev; Ofev 100 mg capsule; Ofev 150 mg capsule; Omeprazole; Omeprazole (UK licensed generic product); Other: 60% Oxygen; Other: Control; Other: Cough monitor; Other: Medical air; Other: No Intervention: Standard of Care; Other: Oxygen; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min); Other: Pulmonary rehabilitation program; Other: Standard of Care; Other: Untreated Cohort; Oxygen; Oxygen 40 %; PA101; PAMREVLUMAB; PBI4050; PD00377 Na-salt; PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714; PIR, S-7701; PIRFENIDONE; PLN-74809; PLN-74809-000; PREDNISOLONE; PRIVIGEN 100mg/ml; PRM-151; PZN 8881655(RochePharma AG); Paclitaxel; Pamrevlumab; Pirfenidone; Pirfenidone and nintedanib; Pirfenidone or nintedanib; Pirfenidoneone; Placebo; Pomalidomide; Pomalidomide (CC-4047; Prednisolone; Prednisone; Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution; Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF); QAX576; Quercetin; RIXATHON 500 mg; RO0220912; RO0280296; RO5490255; RO5490255/F01-02; RVT-1601; RVT-1601 (formerly, PA101B); Radiation: FDG PET scan; Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion; Radiation: Knottin tracer; Remicade; Revatio; Revatio 20 mg; Rituximab; Ro 47-0203; SAR156597; SEPTRIN; SILDENAFIL; SM04646; SODIUM CROMOGLICATE; SULFAMETHOXAZOLE; Salbutamol; Saracatinab; Septrin; Sildenafil; Sildenafil (50 mg); Sildenafil Citrate; Sildenafil and Losartan; Simtuzumab; Sirolimus; Sivelestat; Standard Steroid Treatment; Standard of Care; Sterile Normal Saline for Intravenous Use; Sub-Study: Nintedanib; Sub-Study: Pirfenidone; Sulfamethoxazole; Sulfate; Sulphamethoxazole; Symbicort; TBC; TD-1058; TD139; TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A; TR0311; TRACLEER; TRIMETHOPRIM; TRK-250; Tacrolimus; Tetrandrine; Tetrathiomolybdate; Thalidomide; Thalidomide Pharmion; The Standard Steroid Treatment, Plasma Exchange and rituximab; Thiotepa; Thrombomodulin Alfa; Thrombomodulin alfa; Tiotropium; Tipelukast; Tracleer; Traditional Chinese Medicine Formulation; Tralokinumab; Tralokinumab cohort 1; Tralokinumab cohort 2; Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor; Treatment as Usual (TAU); Treprostinil; Treprostinil sodium for inhalation; Trimethoprim; UROMITEXAN; Uromitexan; VAY736; VISMODEGIB; VOLIBRIS; VRP700; Valganciclovir; Vasoactive intestinal peptide; Vismodegib; Volibris; Warfarin; Xenon; ZL-2102; ZSP1603 12.5 mg; ZSP1603 25 mg; ZSP1603 50 mg; ZSP1603 7.5 mg; Zileuton; Ziritaxestat; [18F]-FBA-A20FMDV2; [18F]FP-R01-MG-F2; [68Ga]CBP8; [BG00011]; [RVT-1601 (in precedenza PA101B)]

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	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
3	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
4	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
5	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
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-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
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-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
9	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
10	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
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-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
12	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
13	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

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

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

Phase 1;Phase 2

United States

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

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

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

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

EUCTR2012-000564-14-AT
(EUCTR)

19/07/2013

11/06/2013

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

EUCTR2012-000564-14-DE
(EUCTR)

17/07/2013

29/05/2013

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

EUCTR2012-000564-14-IT
(EUCTR)

17/07/2013

07/06/2013

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

EUCTR2012-000564-14-SE
(EUCTR)

25/06/2013

24/05/2013

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

EUCTR2012-000564-14-BE
(EUCTR)

18/06/2013

30/04/2013

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

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

Not selected

Japan

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

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

Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo

,NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

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

Not selected

Japan

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