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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Emphysema	Device: Treatment plus Optimal Medical Therapy; Other: Optimal Medical Therapy	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Study Start Date :	June 2012
Actual Primary Completion Date :	November 2013
Actual Study Completion Date :	November 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Treatment plus Optimal Medical Therapy; Patients will be treated with the AeriSeal System and Optimal Medical Therapy	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
Active Comparator: Optimal Medical Therapy; Patients will be treated according to Optimal Medical Therapy	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).

Outcome Measures

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Primary Outcome Measures :

1. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 12 Months ]
   Change from baseline measurement of FEV1

Secondary Outcome Measures :

1. Patient Reported Outcomes [ Time Frame: 12 Months ]
   Change in Patient reported outcome from baseline.
2. Exercise Capacity [ Time Frame: 12 months ]
   The change from baseline in Exercise Capacity
3. Radiological Changes [ Time Frame: 12 months ]
   The radiological changes from baseline.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 40 Study Locations

Sponsors and Collaborators

Aeris Therapeutics

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Come CE, Kramer MR, Dransfield MT, Abu-Hijleh M, Berkowitz D, Bezzi M, Bhatt SP, Boyd MB, Cases E, Chen AC, Cooper CB, Flandes J, Gildea T, Gotfried M, Hogarth DK, Kolandaivelu K, Leeds W, Liesching T, Marchetti N, Marquette C, Mularski RA, Pinto-Plata VM, Pritchett MA, Rafeq S, Rubio ER, Slebos DJ, Stratakos G, Sy A, Tsai LW, Wahidi M, Walsh J, Wells JM, Whitten PE, Yusen R, Zulueta JJ, Criner GJ, Washko GR. A randomised trial of lung sealant versus medical therapy for advanced emphysema. Eur Respir J. 2015 Sep;46(3):651-62. doi: 10.1183/09031936.00205614. Epub 2015 Apr 2.

Responsible Party:	Aeris Therapeutics
ClinicalTrials.gov Identifier:	NCT01449292 History of Changes
Other Study ID Numbers:	03-C11-003PLV
First Posted:	October 10, 2011
Last Update Posted:	November 14, 2013
Last Verified:	November 2013

Keywords provided by Aeris Therapeutics:

PLVR; ELVR; AeriSeal System; foam sealant; emphysematous lung sealant; ELS; COPD	emphysema; polymeric lung volume reduction; heterogeneous; Respiratory Tract Diseases; Lung Diseases; Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:

Emphysema; Pulmonary Emphysema; Pathologic Processes; Pulmonary Disease, Chronic Obstructive	Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases