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OpenTrials
Completed

NCT Number: NCT00825578

Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years
  • Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
  • Moderate to severe airflow obstruction FEV1 <50% Predicted
  • Severe dyspnoea - mMRC ≥2
  • Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
  • SWT ≥75m
  • Optimum COPD treatment for at least 6 weeks
  • No COPD exacerbation for at least 6 weeks
  • Less than 4 admissions for exacerbation in the preceding 12 months

Exclusion criteria

  • Patient unable to provide informed consent
  • Patient without clear targets for airflow re-distribution
  • Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
  • pO2 on air <6.0kPa
  • pCO2 on air >8.0kPa
  • Neurological, rheumatological or other cause of exercise limitation
  • Other major medical illness, e.g. lung cancer that will limit participation
  • Production of purulent sputum more often than not (more than 50% of days)
  • Clinically significant bronchiectasis
  • Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
  • Arrhythmia or cardiovascular disease that poses a risk during procedure or exercise
  • Prednisolone dose greater than 15mg a day
  • Significant pulmonary hypertension - RVSP ≥45mmHg
  • Left ventricular failure - left ventricular ejection fraction <45% or left ventricular fraction shortening <23%
  • Prior LVRS or lobectomy
  • Lung nodule requiring surgery
  • Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment
  • Female of childbearing age with positive pregnancy test
  • Subject participated in a research study of investigational drug or device in prior 30 days
  • Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

Treatment and study plan

Intra-bronchial valve (Spiration IBV)

Device

Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.

Other names: Spiration IBV

Primary outcomes

  1. To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan

    Time frame: 6 months

Secondary outcomes

  1. To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan

    Time frame: 6 months

  2. To estimate the difference between study arms in residual volume

    Time frame: 6 months

  3. To estimate the difference between study arms in FEV1

    Time frame: 6 months

  4. To estimate the difference between study arms in gas transfer

    Time frame: 6 months

  5. To estimate the difference between study arms in modified MRC dyspnoea score

    Time frame: 6 months

  6. To estimate the difference between study arms on a 6 minute walk test

    Time frame: 6 months

  7. To estimate the difference between study arms in disease specific health status

    Time frame: 6 months

  8. To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry

    Time frame: 6 months

  9. To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2009
Registry last updated
Feb 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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