Status:
COMPLETED
Exhale (R) Stent for Emphysema
Lead Sponsor:
Broncus Technologies
Conditions:
Emphysema
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Current treatment for emphysema is limited to measures that include inhaled oxygen, bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation. Highly invasive procedures such as lung volum...
Detailed Description
Emphysema affects an estimated 60 million people worldwide and is a major cause of morbidity and mortality. In its most basic terms, emphysema causes the destruction of lung parenchyma resulting in co...
Eligibility Criteria
Inclusion
- High resolution computed tomography (CT) scan evidence of bilateral emphysema
- Residual volume (RV) ≥ 220% predicted.
- Total lung capacity (TLC) ≥ 133% of predicted value.
- Forced expiratory volume (FEV1) \< 40% of predicted or FEV1 \< 1 liter.
- Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
- Patient has undergone pulmonary rehabilitation of 16 - 20 sessions.
Exclusion
- FEV1 \> 20%
- Diffusing capacity for carbon monoxide (DLco) \< 15% of predicted.
- Respiratory infection requiring \> 3 hospitalizations in past year
- Inability to walk \> 140 meters in 6 minutes
- Giant bulla \> 1/3 of one lung's volume
- Previous lung volume reduction surgery (LVRS) or lobectomy.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00207337
Start Date
July 1 2004
End Date
May 1 2006
Last Update
January 23 2008
Active Locations (6)
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1
The Prince Charles Hospital
Rode Road, Chermside, Queensland, Australia, 4032
2
The Alfred Hospital
Prahran, Victoria, Australia, 3181
3
Concord Repatriation General Hospital
Burwood, Australia, 2134
4
Irmandade Santa Casa de Misericordia
Porto Alegre, Brazil, 90020-090