Aeris is conducting a Phase 3 program evaluating the safety and efficacy of the Biologic Lung Volume Reduction (BLVR) System in patients with advanced upper lobe predominant emphysema.  The BLVR System is an investigational product administered bronchoscopically to targeted areas of the lung, and is designed to initiate an inflammatory response leading to the formation of localized scar tissue and consequent volume reduction.  Preliminary results indicate that the treatment is well tolerated and improves pulmonary function in some emphysema patients.  The most common related adverse experiences are fever, elevations in WBC count, increased shortness of breath, nausea and non-cardiac chest pain, all typically resolving 1 to 2 days post treatment. 

Patients will be divided into two groups randomized at a ratio of 2:1 (treatment:sham control).  All patients will receive standard medical therapy in addition to BLVR or sham procedure.  After the control patients complete the follow-up period, they can be re-evaluated and if eligible, receive BLVR treatment.

Patients will be required to participate in a screening period prior to enrollment in the study.  In addition, they must be willing to participate in a pulmonary rehabilitation program.  

Major study criteria are listed below:

Inclusion Criteria

·          Clinical diagnosis of advanced (Gold stage 3 or 4) upper lobe predominant emphysema

·          Failure of standard medical therapy to relieve symptoms

·          Age ≥ 40 years

·          Clinically significant dyspnea (MRC Score ≥ 2 at screening)

·          PFTs within protocol required ranges (FEV₁ < 50% predicted; TLC > 100% predicted; RV > 135% predicted)

·          Six minute walk test ≥ 150m

Exclusion Criteria 

·          Body mass index < 15 kg/m2 or > 35 kg/m

·          Female patient pregnant or breast feeding

·          Clinically significant asthma, chronic bronchitis or bronchiectasis

·          Tobacco use within 16 weeks of screening

·          Regular use of prednisone >20 mg/day, immunosuppressive agents, heparins, oral anticoagulants (e.g. warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted)

·          Allergy or sensitivity to tetracycline and/or lidocaine, or any of the BLVR components

·          Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening visit

·          Prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement (unless removed), prior BLVR treatment, prior airway stent placement or pleurodesis

·          History of renal infarction or renal failure. 

·          Significant comorbid conditions that carry prohibitive risks (e.g. HIV/AIDS, cancer) or is associated with less than 2-year expected survival.

·          FEV1 <20% predicted with DLco <20% predicted

·          Any condition that the principal investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or non-compliance in returning for follow-up visits.

Further information regarding clinical studies sponsored by Aeris may be found at www.clinicaltrials.gov; enter “Aeris” in the “Search Clinical Trials” box.

Click here to see a list of participating sites. 

If you would like more information regarding current or future studies, please contact:

Clinical Affairs

Aeris Therapeutics, Inc.

10K Gill Street

Woburn, MA 01801

781-937-0110

Click here to request information via e-mail