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Completed

NCT Number: NCT00884962

A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.

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Key information

Conditions

Advanced Emphysema Emphysema Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chefarzt Klinik für Pneumologie, Bad Berka, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have a diagnosis of advanced upper lobe predominant (ULP) emphysema or advanced disease in the superior lower lobes as defined by FEV1/FVC <70 % predicted, FEV1 of < 50% predicted, TLC > 100% of predicted, and RV > 135% predicted.
  • Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
  • Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Treatment and study plan

Polymeric Lung Volume Reduction System (PLVR)

Device

20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment.

Primary outcomes

  1. Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)

    Time frame: 12 and 24 weeks following treatment

    Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment

Secondary outcomes

  1. Change in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: 12 and 24 weeks following treatment

    o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment

  2. Change in Forced Vital Capacity (FVC)

    Time frame: 12 and 24 weeks following treatment

    Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment

  3. Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)

    Time frame: 12 and 24 weeks following treatment

    Change from baseline in DLco at 12 and 24 weeks following treatment

  4. Change in Medical Research Council Dyspnea (MRCD) score

    Time frame: 12 and 24 weeks following treatment

    Change from baseline in MRCD score at 12 and 24 weeks

  5. Change in distance walked in six minutes

    Time frame: 12 and 24 weeks following treatment

    Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)

  6. Change in St. George's Respiratory Questionnaire (SGRQ) domain score

    Time frame: 12 and 24 weeks following treatment

    Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment

Sponsors and collaborators

Lead sponsor

Aeris Therapeutics

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 21, 2009
Registry last updated
Oct 21, 2011

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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