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Pulmonary EmphysemaPhase 3ASPIRENCT01449292

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

A Phase 3 study testing Treatment plus Optimal Medical Therapy and Optimal Medical Therapy in people with Pulmonary Emphysema, run by Aeris Therapeutics at 40 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Emphysema
What is being tested?
Treatment plus Optimal Medical Therapy and Optimal Medical Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
40 sitesin 7 countries
Study dates
Jun 2012to Nov 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide informed consent
  • Age ≥ 40 years
  • On optimal medical therapy* for more than 1 month
  • Advanced upper lobe predominant emphysema confirmed by CT scan
  • Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in each lung based upon CT scan (total 4 available subsegments)
  • MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4)
Show all 18Show fewer
  • 6MWT distance ≥ 150 m post pulmonary rehab
  • Spirometry 15 minutes after administration of a bronchodilator showing BOTH:
  • FEV1 < 50% predicted
  • FEV1/FVC ratio < 70%
  • Plethysmographic lung volumes showing BOTH:
  • TLC > 100% predicted
  • RV > 150% predicted
  • DLco ≥ 20% and ≤ 60% predicted
  • Blood gases and oxygen saturation showing BOTH:
  • SpO2 ≥ 90% on ≤ 4 L/min supplemental O2
  • PaCO2 < 65 torr
  • Smoking history of ≥ 20 pack-years with abstinence for 16 weeks

Who cannot join

  • Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
  • Requirement for ventilator support (other than CPAP or BPAP for sleep apnea)
  • Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks
  • Use of systemic steroids > 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants or investigational medications
  • a-1 antitrypsin serum level of < 80 mg/dL (immunodiffusion) or < 11 µmol/L (nephelometry)
  • CT scan: Presence of any of the following radiologic abnormalities:
Show all 26Show fewer
  • Pulmonary nodule on CT scan greater than 1.0 cm in diameter
  • Radiologic picture consistent with active pulmonary infection
  • Significant interstitial lung disease
  • Significant pleural disease
  • Giant bullous disease
  • Clinically significant asthma
  • Clinically significant bronchiectasis
  • Pulmonary hypertension
  • Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious (moderate procedural) sedation
  • Participation in an investigational study of a drug, biologic, or device not currently approved for marketing
  • Body mass index < 15 kg/m2 or > 35 kg/m2
  • Female patient pregnant or breast-feeding or planning to be pregnant in the next year
  • Any abnormal screening laboratory test result
  • Significant comorbidity including any of the following:
  • HIV/AIDs
  • Active malignancy
  • Stroke or TIA within 12 months
  • Myocardial infarction within 12 months
  • Congestive heart failure within 12 months
  • 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

Trial locations and contacts

40 sites in 7 countries.

40 sites in 7 countries

United States29 sites

  • Emory University Hospital

    Atlanta, Georgia, 30308

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of South Carolina School of Medicine

    Columbia, South Carolina, 29203

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 55242

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Presence Saint Joseph Medical Center

    Joliet, Illinois, 60435

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • Miami VA Healthcare System (accepting Miami VA patients only)

    Miami, Florida, 33136

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • South Nassau Communities Hospital

    Oceanside, New York, 11572

  • Illinois Lung Institute

    Peoria, Illinois, 61606

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Pulmonary Associates

    Phoenix, Arizona, 85006

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Kaiser Foundation Hospitals (accepting Kaiser patients only)

    Portland, Oregon, 97227

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84112

  • Washington University

    St Louis, Missouri, 63110

  • Veritas Clinical Specialties, Ltd.

    Topeka, Kansas, 66606

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain4 sites

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Clínica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46009

Other trials in Spain

France3 sites

  • CHU de Grenoble

    Grenoble, 38043

  • CHU de Nice

    Nice, 06002

  • Hôpital Maison Blanche

    Reims, 51092

Other trials in France

Greece1 site

  • University of Athens - Sotiria General Hospital

    Athens, 11527

Other trials in Greece

Israel1 site

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

Italy1 site

  • Azienda Ospedaliera Spedali Civili de Brescia

    Brescia, 25123

Other trials in Italy

Netherlands1 site

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

Other trials in Netherlands

About this study

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.

Being tested
Treatment plus Optimal Medical Therapy, Optimal Medical Therapy
Keywords
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
Medical subject headings
Pulmonary Emphysema, Pulmonary Disease, Chronic Obstructive, Emphysema, Respiratory Tract Diseases, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment plus Optimal Medical TherapyDevice

    Also called AeriSeal System

    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).

  • Optimal Medical TherapyOther

    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).

Study groups in NCT01449292
Study groupRoleWhat they receive
Treatment plus Optimal Medical TherapyExperimentalPatients will be treated with the AeriSeal System and Optimal Medical Therapy
Receives: Device: Treatment plus Optimal Medical Therapy
Optimal Medical TherapyActive comparatorPatients will be treated according to Optimal Medical Therapy
Receives: Other: Optimal Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced Expiratory Volume in 1 second (FEV1)

    Change from baseline measurement of FEV1

    Measured: 12 Months

Secondary outcomes (3)

  1. Patient Reported Outcomes

    Change in Patient reported outcome from baseline.

    Measured: 12 Months

  2. Exercise Capacity

    The change from baseline in Exercise Capacity

    Measured: 12 months

  3. Radiological Changes

    The radiological changes from baseline.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2011 (estimated)
  2. Study startJun 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01449292
Sponsor's protocol ID
03-C11-003PLV
Acronym
ASPIRE
Status last verified
Nov 2013
First submitted
6 Oct 2011
Last updated
14 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25837041

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Treatment plus Optimal Medical Therapy and Optimal Medical Therapy in people with Pulmonary Emphysema, run by Aeris Therapeutics at 40 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain, France, Greece, Israel and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Expiratory Volume in 1 second (FEV1) (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01449292, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.

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