Endobronchial Valves in Moderate COPD

NCT01969734 | Completed

• 1 other identifier: SFH2
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the best medical therapy many people with emphysema remain breathless and limited in their daily activities. In emphysema the lungs do not empty properly when the person breathes out. This "gas trapping" makes it harder to breathe. Endobronchial valve placement, a treatment that stops air getting into the worst affected parts of the lung and so stops them from trapping gas, improves lung function, breathlessness and exercise capacity in selected patients with severe COPD (chronic obstructive airways disease, sometimes referred to as emphysema). We want to see if people with less severe COPD who are very breathless can benefit from the same treatment. The treatment involves placing small valves into the airways using a fibre optic camera (a bronchoscopy). Bronchoscopy is a standard clinical procedure carried out in our department.

Conditions

Moderate COPD

Keywords

Emphysema; Moderate COPD; Hyperinflation; Endobronchial valves

Outcome Measures

Primary Outcomes (1)

• Change in residual volume

  3 months following treatment

Secondary Outcomes (9)

• Change in FEV1

  3 months following treatment

• Change in vital capacity

  3 months following treatment

• Change in RV/TLC ratio

  3 months following treatment

• Change in the SGRQ score

  3 months following treatment

• Change in the MRC score

  3 months following treatment

Study Arms (1)

Endobronchial valves

EXPERIMENTAL

All subjects will have endobronchial valves inserted into the target lobe of the lung with the aim of complete lobar exclusion.

Device: Zephyr endobronchial valve placement

Interventions

Zephyr endobronchial valve placement DEVICE

Endobronchial valves

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with stable moderate COPD (FEV1 45-80%pred)
• Emphysema on CT with a defined target lobe
• CT thorax must demonstrate intact interlobar fissures adjacent to the target lobe
• Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted
• Exertional breathlessness with MRC dyspnoea score ≥3
• Optimum COPD treatment for at least 6 weeks
• No COPD exacerbation for at least 6 weeks
• Fewer than 3 admissions for infective exacerbations in the preceding 12 months
• Six minute walk distance of \<450m

You may not qualify if:

• Inability to obtain informed consent
• Significant co morbidity which limits exercise capacity or prognosis
• Co-morbidities that would render bronchoscopy or sedation unsafe
• Clinically significant bronchiectasis
• Lung nodule requiring further investigation or treatment
• Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

Sponsors & Collaborators

• Sherwood Forest Hospitals NHS Foundation Trust: lead

Study Sites (1)

Kings Mill Hospital

Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom

Location

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 25, 2013
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

GB (1)