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To Improve Lung Function and Symptoms for Emphysema Patients Using Zephyr Valves (TRANSFORM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02022683
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pulmonx Corporation

Brief Summary:
To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.

Condition or disease Intervention/treatment Phase
COPD Heterogeneous Emphysema Device: ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
Actual Study Start Date : January 28, 2014
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema Endoscopy

Arm Intervention/treatment
Experimental: Endoscopic Lung Volume Reduction
Patients are implanted with Zephyr Valves
Device: ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves
No Intervention: Standard of Care
Patients are given Standard Medical Care



Primary Outcome Measures :
  1. Forced Expiratory Volume in 1-second (FEV1) - Responders [ Time Frame: Between baseline and 3 months ]
    The percentage of trial participants in the EBV treatment arm meeting the minimally clinically important difference (MCID) of >12% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 3 months post-procedure.


Secondary Outcome Measures :
  1. St George's Respiratory Questionnaire (SGRQ) - Absolute change [ Time Frame: Between Baseline and 3, 6, 12, 18 and 24 months ]

    Absolute change in the SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.

    The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:

    Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)

    A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.


  2. St George's Respiratory Questionnaire (SGRQ) - Percent change [ Time Frame: Between Baseline and 3, 6, 12, 18 and 24 months ]

    Percent change in the SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.

    The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:

    Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)

    A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.


  3. St George's Respiratory Questionnaire (SGRQ) - Responders [ Time Frame: Between Baseline and 3, 6, 12, 18 and 24 months ]

    Percentage of subject achieving the MCID for SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months, compared to SoC at 3, 6 and 12 months.

    The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:

    Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)

    A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.


  4. 6-minute walk distance (6MWT) - Absolute change [ Time Frame: Between Baseline and 3, 6, 12, 18, 24 months ]
    Absolute change in 6MWD in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.

  5. 6-minute walk distance (6MWT) - Percent change [ Time Frame: Between Baseline and 3, 6, 12, 18, 24 months ]
    Percent change in 6MWD in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.

  6. 6-minute walk distance (6MWT) - Responders [ Time Frame: Between Baseline and 3, 6, 12, 18, 24 months ]
    Percentage of subject achieving the MCID for 6MWD in the EBV treatment arm at 3, 6, 12, 18 and 24 months, compared to SoC at 3, 6 and 12 months.

  7. Forced Expiratory Volume in 1-second (FEV1) - Absolute change [ Time Frame: Between Baseline and 3, 6, 12, 18, 24 months ]
    Absolute change in FEV1 in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.

  8. Forced Expiratory Volume in 1-second (FEV1) - Percent change [ Time Frame: Between Baseline and 6, 12, 18 and 24 months ]
    Percentage of subject achieving the MCID for FEV1 in the EBV treatment arm at 6, 12, 18 and 24 months, compared to SoC at 6 and 12 months.

  9. Forced Expiratory Volume in 1-second (FEV1) - Responders [ Time Frame: Between Baseline and 3, 6, 12, 18, 24 months ]
    Absolute change in FEV1 in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.

  10. mMRC (Modified Medical Research Council) score - Responders [ Time Frame: Between Baseline and 3, 6, 12, 18 and 24 months ]

    Percentage of subject in the EBV treatment arm achieving the MCID for the Modified Scale Research Council Dyspnea Score (mMRC) at 3, 6, 12, 18 and 24 months and the difference between the two arms at 3, 6 and 12 months.

    The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.


  11. Target Lobar Volume Reduction (TLVR) - Absolute change [ Time Frame: Between baseline and 45 days ]
    Absolute change in target lobe volume at 45 days in the EBV treatment arm relative to Baseline as assessed by quantitative HRCT analysis (TLVR: Target Lobar Volume Reduction).

  12. Target Lobar Volume Reduction (TLVR) - Percent change [ Time Frame: Between baseline and 45 days ]
    Percent change in target lobe volume at 45 days in the EBV treatment arm relative to Baseline as assessed by quantitative HRCT analysis (TLVR: Target Lobar Volume Reduction).

  13. Target Lobar Volume Reduction (TLVR) - Responders [ Time Frame: Between baseline and 45 days ]
    Percentage of subjects in EBV arm with a TLVR > 350ml at 45 days relative to baseline.


Other Outcome Measures:
  1. Adverse Events [ Time Frame: Between baseline and 24 months ]
    Adverse events (condition/procedure related AE's, SAE's, ADE's and SADE's) occurring up to 24 months post EBV placement and up to 12 months post randomization (for any remaining subjects in the SoC group).

  2. PaO2 - Absolute change [ Time Frame: Between baseline and 3 months ]
    Absolute change in PaO2 in the EBV treatment arm at 3 months relative to Baseline.

  3. PaO2 - Percent change [ Time Frame: Between baseline and 3 months ]
    Percent change in PaO2 in the EBV treatment arm at 3 months relative to Baseline.

  4. Residual Volume (RV) - Absolute change [ Time Frame: Between Baseline and 3, 6 and 12, 18 and 24 months ]
    Absolute change in residual volume (RV) in the EBV treatment arm at 3, 6 and 12, 18 and 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.

  5. Residual Volume (RV) - Percent change [ Time Frame: Between Baseline and 3, 6 and 12, 18 and 24 months ]
    Percent change in residual volume (RV) in the EBV treatment arm at 3, 6 and 12, 18 and 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.

  6. EQ-5D Summary Index - Absolute change [ Time Frame: Between Baseline and 3, 6, 12, 18 and 24 months ]

    Absolute change relative to Baseline in the EBV treatment arm at 3, 6, 12, 18 and 24 months of the EQ-5D Summary Index and the difference between the two arms at, 3, 6 and 12 months.

    EQ-5D is a standardized instrument used to measure health-related quality of life for a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS.

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.


  7. EQ-5D Summary Index Percent change [ Time Frame: Between Baseline and 3, 6, 12, 18 and 24 months ]

    Percent change relative to Baseline in the EBV treatment arm at 3, 6, 12, 18 and 24 months of the EQ-5D Summary Index and the difference between the two arms at, 3, 6 and 12 months.

    EQ-5D is a standardized instrument used to measure health-related quality of life for a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS.

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.


  8. Mean number of additional hospitalizations and/or visits caused by respiratory conditions [ Time Frame: Between baseline and 24 months ]
    The mean number of visits (Number of participants reporting visits/total number of visits) caused by respiratory conditions during the study period will be recorded for health economical purposes in both treatment and control subjects.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Obtained informed consent.
  2. Diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes.
  3. Subjects of both genders of at least 40 years of age.
  4. 15 % predicted ≤ FEV1≤ 45% predicted.
  5. TLC > 100% and RV ≥ 180% predicted.
  6. 150 meters < 6MWD < 450 meters.
  7. Non-smoker >8 weeks prior to signing the Informed Consent.
  8. CV negative target lobe.

Additional inclusion criterion French CIP*:

- If treated in France, Subject must be entitled to French social security

Exclusion Criteria:

  1. Any contraindication for bronchoscopic procedure.
  2. Evidence of active pulmonary infection.
  3. History of 2 or more exacerbations requiring hospitalization over the past 12 months.
  4. Known pulmonary hypertension that according to the physician will be unsuitable for EBV treatment.
  5. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
  6. Significant bronchiectasis seen at CT scan.
  7. Greater than two tablespoons of sputum production per day.
  8. Prior LVR or LVRS procedure. Criterion 8 French CIP wording*: Prior lung transplant, median sternotomy, LVR or LVRS procedure (including lobectomy).
  9. Pulmonary nodule requiring follow-up within any lobe.
  10. Pregnant or nursing women. French CIP wording*: Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
  11. Hypercapnia (paCO2 > 7.33 kPa).
  12. Current diagnosis of asthma.
  13. > 25mg Prednisolon (or equivalent) use/days.
  14. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate.
  15. Evidence of pleural adhesions or earlier pulmonary surgery.
  16. Severe Bullous Emphysema (> 1/3 Hemithorax)
  17. Any subject that according to the Declaration of Helsinki is unsuitable for enrollment.

Additional exclusion criteria in the French CIP*:

  • History of allergy to silicone and/or nitinol.
  • If treated in France, Subject is a "personne vulnerable" as defined by French regulation.
  • Simultaneous participation in another drug and/or medical device related clinical.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022683


Locations
Show Show 17 study locations
Sponsors and Collaborators
Pulmonx Corporation
Investigators
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Principal Investigator: Gunnar Hillerdal, MD, PhD Uppsala University Hospital Sweden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pulmonx Corporation
ClinicalTrials.gov Identifier: NCT02022683    
Other Study ID Numbers: 630-0015/A
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pulmonx Corporation:
Endoscopic lung volume reduction
Endobronchial valves
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases