NCT00825578

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 6, 2012

Status Verified

February 1, 2012

Enrollment Period

1.9 years

First QC Date

January 19, 2009

Last Update Submit

February 3, 2012

Conditions

Heterogeneous Emphysema

Keywords

intrabronchial valveheterogeneous emphysemanon-upper lobe

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (9)

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

    6 months

  • To estimate the difference between study arms in residual volume

    6 months

  • To estimate the difference between study arms in FEV1

    6 months

  • To estimate the difference between study arms in gas transfer

    6 months

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

    6 months

  • +4 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Upper-lobe predominant emphysema

Device: Intra-bronchial valve (Spiration IBV)

2

ACTIVE COMPARATOR

Non-upper lobe predominant emphysema

Device: Intra-bronchial valve (Spiration IBV)

Interventions

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.

Also known as: Spiration IBV
12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Study Officials

  • Pallav Shah, MBBS, MD

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2009

First Posted

January 21, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 6, 2012

Record last verified: 2012-02

Locations

GB(1)