Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01449292
First received: October 6, 2011
Last updated: November 13, 2013
Last verified: November 2013

October 6, 2011
November 13, 2013
June 2012
November 2013   (final data collection date for primary outcome measure)
Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Change from baseline measurement of FEV1
Change in Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Change from baseline measurment of FEV1 at 6 months post-treatment.
Complete list of historical versions of study NCT01449292 on ClinicalTrials.gov Archive Site
  • Patient Reported Outcomes [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Change in Patient reported outcome from baseline.
  • Exercise Capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The change from baseline in Exercise Capacity
  • Radiological Changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The radiological changes from baseline.
  • Change in FEV1 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Change in FEV1 from baseline measurement at 12 Months post-procedure
  • Change in Forced Vital Capacity (FVC) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Change in the FVC from baseline measurement at 6 and 12 months post-procedure
  • Change in 6 Minute Walk Test (6MWT) distance [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Change in distance walked in 6 minutes from baseline measurement at 6 and 12 months post-procedure.
  • Change in health related quality of life [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Change in health related quality of life, measure in terms of St. George's Respiratory Questionnaire total domain score from baseline score at 6 and 12 months post-procedure.
  • Change in Residual Volume (RV) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Change in RV measurement from baseline at 6 and 12 months post-procedure
  • Change in Residual Volume to Total Lung Capacity (RV/TLC) ratio [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Change in RV/TLC ratio from baseline at 6 and 12 months post-procedure
Not Provided
Not Provided
 
Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Emphysema
  • Device: Treatment plus Optimal Medical Therapy
    Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
    Other Name: AeriSeal System
  • Other: Optimal Medical Therapy
    Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
  • Experimental: Treatment plus Optimal Medical Therapy
    Patients will be treated with the AeriSeal System and Optimal Medical Therapy
    Intervention: Device: Treatment plus Optimal Medical Therapy
  • Active Comparator: Optimal Medical Therapy
    Patients will be treated according to Optimal Medical Therapy
    Intervention: Other: Optimal Medical Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Willing and able to provide informed consent
  2. Age ≥ 40 years
  3. On optimal medical therapy* for more than 1 month
  4. Advanced upper lobe predominant emphysema confirmed by CT scan
  5. Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in each lung based upon CT scan (total 4 available subsegments)
  6. MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4)
  7. 6MWT distance ≥ 150 m post pulmonary rehab
  8. Spirometry 15 minutes after administration of a bronchodilator showing BOTH:

    1. FEV1 < 50% predicted
    2. FEV1/FVC ratio < 70%
  9. Plethysmographic lung volumes showing BOTH:

    1. TLC > 100% predicted
    2. RV > 150% predicted
  10. DLco ≥ 20% and ≤ 60% predicted
  11. Blood gases and oxygen saturation showing BOTH:

    1. SpO2 ≥ 90% on ≤ 4 L/min supplemental O2
    2. PaCO2 < 65 torr
  12. Smoking history of ≥ 20 pack-years with abstinence for 16 weeks

Exclusion Criteria:

  1. Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
  2. Requirement for ventilator support (other than CPAP or BPAP for sleep apnea)
  3. Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks
  4. Use of systemic steroids > 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants or investigational medications

    Exclusion Criteria (continued):

  5. a-1 antitrypsin serum level of < 80 mg/dL (immunodiffusion) or < 11 µmol/L (nephelometry)
  6. CT scan: Presence of any of the following radiologic abnormalities:

    1. Pulmonary nodule on CT scan greater than 1.0 cm in diameter
    2. Radiologic picture consistent with active pulmonary infection
    3. Significant interstitial lung disease
    4. Significant pleural disease
    5. Giant bullous disease
  7. Clinically significant asthma
  8. Clinically significant bronchiectasis
  9. Pulmonary hypertension
  10. Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious (moderate procedural) sedation
  11. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing
  12. Body mass index < 15 kg/m2 or > 35 kg/m2
  13. Female patient pregnant or breast-feeding or planning to be pregnant in the next year
  14. Any abnormal screening laboratory test result
  15. Significant comorbidity including any of the following:

    1. HIV/AIDs
    2. Active malignancy
    3. Stroke or TIA within 12 months
    4. Myocardial infarction within 12 months
    5. Congestive heart failure within 12 months
  16. Any condition that would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Greece,   Israel,   Italy,   Netherlands,   Spain
 
NCT01449292
03-C11-003PLV
Yes
Aeris Therapeutics
Aeris Therapeutics
Not Provided
Not Provided
Aeris Therapeutics
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP