Clinical trials: Emphysema, Pulmonary
Alpha-1 Antitrypsin Deficiency
Long-Term Follow-up Study of ADVM-043
ADVM-043-03 is a long-term follow-up (LTFU) study of subjects who participated in the ADVM-043-01 (NCT02168686) multi-center gene therapy clinical study (ADVANCE) that evaluated ADVM-043 for the treatment of Alpha-1 Antitrypsin…
- Trial name
- NCT03804021
- Testing
- No Intervention
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Adverum Biotechnologies, Inc.
Advanced Upper Lobe Predominant Emphysema
Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in treating patients with advanced upper lobe predominant emphysema.
- Trial name
- NCT00716053
- Testing
- BLVR
- Volunteers
- 225 people
- Sponsor
- Aeris Therapeutics
Emphysema
Exhale (R) Stent for Emphysema
Current treatment for emphysema is limited to measures that include inhaled oxygen, bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation.
- Trial name
- NCT00207337
- Testing
- Exhale Drug-Eluting Stent
- Where
- 6 sites in Australia, Brazil and 1 more
- Volunteers
- 60 people
- Sponsor
- Broncus Technologies
Alpha 1-Antitrypsin Deficiency
Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype
This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-814 in PiZZ subjects.
- Trial name
- NCT04167345
- Testing
- VX-814
- Where
- 28 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Chronic Pulmonary Obstructive Disease, Emphysema
A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema
The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.
- Trial name
- NCT01449175
- Where
- 8 sites in Austria, France and 2 more
- Volunteers
- 54 people
- Sponsor
- Aeris Therapeutics
Alpha1-antitrypsin Deficiency
Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha 1-antitrypsin deficiency.
- Trial name
- NCT00161707
- Testing
- Aerosolized, Recombinant Alpha 1-Antitrypsin
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Baxalta now part of Shire
Pulmonary Disease, Chronic Obstructive
ICS/LABA Adherence and COPD Exacerbation
The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD…
- Trial name
- NCT02446041
- Testing
- Non-Interventional Study
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- AstraZeneca
Alpha1-Antitrypsin Deficiency
Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran…
- Trial name
- NCT05677971
- Testing
- Fazirsiran Injection
- Where
- 89 sites in United States, Australia and 17 more
- Volunteers
- 160 people
- Sponsor
- Takeda
Pulmonary Emphysema, Chronic Obstructive Pulmonary Disease
Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
The purpose of this study is to evaluate the safety and efficacy of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema refractory to medical therapy.
- Trial name
- NCT00517998
- Testing
- Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel
- Where
- Israel
- Volunteers
- 16 people
- Sponsor
- Aeris Therapeutics
Empyhsema, Pulmonary Disease, Chronic Obstructive
The Spiration Valve System for the Treatment of Severe Emphysema
This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control…
- Trial name
- REACH (NCT01989182)
- Testing
- Spiration Valve System, Medical Management
- Where
- 12 sites in China
- Volunteers
- 107 people
- Sponsor
- Olympus Corporation of the Americas
Cystic Fibrosis
Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and…
- Trial name
- NCT01684410
- Testing
- Alpha-1 HC 100 mg, Alpha-1 HC 200 mg
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Grifols Therapeutics LLC
Emphysema
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
- Trial name
- RENEW (NCT01608490)
- Testing
- RePneu Lung Volume Reduction Coil System
- Where
- 29 sites in United States, Canada and 4 more
- Volunteers
- 315 people
- Sponsor
- Boston Scientific Corporation
Emphysema, Chronic Obstructive Pulmonary Disease
Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the…
- Trial name
- NCT00137956
- Testing
- Emphasys Endobronchial Valve (EBV) Device and Procedure
- Volunteers
- 270 people
- Sponsor
- Emphasys Medical
Alpha-1 Antitrypsin Deficiency, AATD
Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency
This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD)…
- Trial name
- rhAAT-Fc (NCT03815396)
- Testing
- INBRX-101/rhAAT-Fc
- Where
- 10 sites in United States, New Zealand and 1 more
- Volunteers
- 31 people
- Sponsor
- Inhibrx Biosciences, Inc
Alpha-1 Anti-trypsin Deficiency, AATD
A Phase 1/2a, Single- and Multiple-dose Escalation Study of KRRO-110
The purpose of this first-in human (FIH) study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple doses of KRRO-110 in both healthy adult participants and in clinically stable patients with…
- Trial name
- REWRITE (NCT06677307)
- Testing
- KRRO-110
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Korro Bio, Inc.
Emphysema
Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.
- Trial name
- NCT01328899
- Testing
- Lung Volume Reduction Coil (LVRC) (PneumRx's)
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Alpha 1-Antitrypsin Deficiency
A Study of KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency
The Sponsor is developing KB408, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human SERPINA1 to the airways of people with alpha-1…
- Trial name
- Serpentine-1 (NCT06049082)
- Testing
- KB408 (Nebulization)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Krystal Biotech, Inc.
Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD
The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
- Trial name
- NCT00064415
- Testing
- arformoterol, Salmeterol
- Where
- 90 sites in United States
- Volunteers
- 799 people
- Sponsor
- Sumitomo Pharma America, Inc.
Alpha 1-Antitrypsin Deficiency
Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency
The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product.
- Trial name
- Kamada API (NCT00460096)
- Testing
- Kamada-API
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Kamada, Ltd.
Chronic Obstructive Pulmonary Disease
Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)
The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease.
- Trial name
- NCT00891462
- Testing
- Aclidinium bromide
- Where
- 112 sites in United States, Canada
- Volunteers
- 561 people
- Sponsor
- AstraZeneca