A randomized, double-blind study to evaluate the safety and effectiveness of the Exhale Drug-eluting stent in homogeneous emphysema subjects with severe hyperinflation, the "EASE - study". & Local ammendment: Protocol revision to evaluate the ExhaleUltraNeedle in the EASE study.

A randomized, double-blind study to evaluate the safety and effectiveness of the Exhale Drug-eluting stent in homogeneous emphysema subjects with severe hyperinflation, the "EASE - study". & Local ammendment: Protocol revision to evaluate the ExhaleUltraNeedle in the EASE study. - EASE - study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30701

Enrollment

Registered

2006-06-16

Start date

2006-09-27

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Emphysema

Interventions

The Exhale Drug-Eluting Stent is intended for use in the airway bypass procedure to improve the clinical status of emphysema patients with homogeneous disease and severe hyperinflation by increasing

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Homogenous emphysema on CT-thorax Post-bronchodilitator 0,65 no smoking

Exclusion criteria

Exclusion criteria: Recurrent pulmonary infections and bronchiectasis Cardiovasculair pathology PaCO2 >60mmHg Alpha-1 antitrypsin deficiency

Design outcomes

Primary

Measure	Time frame
Safety: The primary safety endpoint is comparison of a composite endpoint between the treatment and control arms. Efficacy: There are two primary efficacy outcomes, FVC and mMRC, which are combined in a responder analysis. A subject is a success (responder) if their FVC improves by at least 12% of their baseline value and their mMRC improves (is reduced) by at least 1 point at their 6-month follow-up visit. In order for superior efficacy to be claimed, the probability of a subject being a responder in the treatment arm must be greater than the control arm. The primary efficacy analysis will be on an intent-to-treat basis on all randomized subjects.	—

Measure

Time frame

Safety: The primary safety endpoint is comparison of a composite endpoint between the treatment and control arms. Efficacy: There are two primary efficacy outcomes, FVC and mMRC, which are combined in a responder analysis. A subject is a success (responder) if their FVC improves by at least 12% of their baseline value and their mMRC improves (is reduced) by at least 1 point at their 6-month follow-up visit. In order for superior efficacy to be claimed, the probability of a subject being a responder in the treatment arm must be greater than the control arm. The primary efficacy analysis will be on an intent-to-treat basis on all randomized subjects.

—

Secondary

Measure	Time frame
Residual Volume Residual Volume/Totale Long Capaciteit ratio Forced Vital Capacity (FVC) modified Medical Research Counsil Dyspnea Scale (mMRC) Forced Expiratory Volume in 1 second (FEV1) St. George's Respiratory Questionnaire (SGRQ)^ 6-minute walk distance Cycle ergometry In ammendement 7.0-UN: Safety and performance of the ExhaleUltraNeedle	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)