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Completed

NCT Number: NCT02022683

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Heterogeneous Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiteit Gent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Additional inclusion criterion French CIP*:

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

Exclusion criteria

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

Treatment and study plan

ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves

Device

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pulmonx Corporation

Industry

Registry information

Official study title

A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema

Acronym: TRANSFORM

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Dec 30, 2013
Registry last updated
Jul 2, 2019

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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