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Biologic Lung Volume Reduction

Phase 2

Homogeneous Emphysema | Monoclonal antibody | Respiratory |cbdMD, Inc.|Last Updated: Oct 24, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

Biologic Lung Volume Reduction · 1 trial · 1 indication

Phase 2 1
NCT00630227Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous StudyHomogeneous Emphysema
COMPLETED33 Analytics
PHASE2COMPLETED
Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study
Homogeneous EmphysemaUnlock trial analytics

Study Endpoints

Primary Endpoints

reduction in gas trapping
12 weeks post treatment

Secondary Endpoints

improvement in exercise capacity
12 weeks post treatment
improvement in expiratory flow
12 weeks post treatment
improvement in vital capacity
12 weeks post treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SingleEXPERIMENTALall patients are treated with the experimental therapy

Interventions

NameTypeDescription
Biologic Lung Volume ReductionBIOLOGICAL20 mL Hydrogel
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * clinical diagnosis of advanced homogeneous or upper lobe predominant emphysema demonstrated by CT scan * age \>/= 40 years * clinically significant dyspnea * failure of standard medical therapy (typically inhaled beta agonist \& inhaled anticholinergic) to relieve symptoms * p...

Countries:United States
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Frequently asked questions about Biologic Lung Volume Reduction

What is Biologic Lung Volume Reduction used for?

Biologic Lung Volume Reduction is an investigational therapy being studied for the treatment of homogeneous emphysema, a form of chronic obstructive pulmonary disease. It is designed to reduce lung volume in patients with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes Biologic Lung Volume Reduction?

Biologic Lung Volume Reduction is being developed by cbdMD, Inc., a company traded on the stock market under the ticker symbol YCBD. The company is conducting clinical research on this therapy for homogeneous emphysema. As of the latest available information, the drug is in Phase 2 clinical development.

What phase is Biologic Lung Volume Reduction in?

Biologic Lung Volume Reduction is in Phase 2 clinical development. It has completed one Phase 2 clinical trial for homogeneous emphysema. The drug is still investigational and has not received regulatory approval. Further clinical studies may be needed to evaluate its safety and efficacy.

What clinical trials is Biologic Lung Volume Reduction in?

Biologic Lung Volume Reduction has been studied in one completed clinical trial with the identifier NCT00630227. This Phase 2 study, titled 'Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study,' enrolled 33 participants with homogeneous emphysema in the United States. The trial was uncontrolled and did not use randomization or blinding.

How does Biologic Lung Volume Reduction work?

Biologic Lung Volume Reduction is a monoclonal antibody designed to target and reduce lung volume in patients with homogeneous emphysema. By binding to specific molecular targets, it aims to modify the lung tissue to improve respiratory function. The exact mechanism of action is part of its investigational profile.

Is Biologic Lung Volume Reduction FDA approved?

Biologic Lung Volume Reduction is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for homogeneous emphysema. The completed clinical trial NCT00630227 has provided initial data, but the therapy has not yet received regulatory approval for commercial use.