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Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema

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Trial Conditions
  • Pulmonary Emphysema
What is the purpose of this trial?

Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
40 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- clinical diagnosis of advanced upper lobe predominant emphysema

- age >/= 40 years

- clinically significant dyspnea

- failure of standard medical therapy to relieve symptoms (inhaled beta agonist and
inhaled anticholinergic)

- pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 <
45% predicted and experiencing < 30% or 300 mL improvement using bronchodilator; TLC
> 110% predicted; RV > 150% predicted)

- 6 Minute Walk Distance >/= 150 m

Exclusion Criteria:

- alpha-1 protease inhibitor deficiency

- homogeneous disease

- tobacco use within 4 months of initial visit

- body mass index < 15 kg/m2 or > 35 kg/m2

- clinically significant asthma, chronic bronchitis or bronchiectasis

- allergy or sensitivity to procedural components

- pregnant, lactating or unwilling to use birth control if required

- prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant,
endobronchial valve placement, airway stent placement or pleurodesis

- comorbid condition that could adversely influence outcomes

- inability to tolerate bronchoscopy under conscious sedation (or anesthesia)

Gender: Both
Steward Physician(s)
  • Victor Pinto-Plata, MD
  • Gerard Criner, MD
  • Mark Gotfried, MD
  • Charlie Strange, MD
  • Mark Dransfield, MD
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Biological
  • BLVR Treatment
Physician Researcher

Investigator Name:

  • Victor Pinto-Plata, MD
  • Gerard Criner, MD
  • Mark Gotfried, MD
  • Charlie Strange, MD
  • Mark Dransfield, MD

Other Information

Sponsor: Aeris Therapeutics
Phase: Phase 2
Trial ID: NCT00435253
Volunteers:  Not Accepting Healthy Volunteers

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