- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01908933
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
13. november 2013 oppdatert av: Aeris Therapeutics
The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
Studieoversikt
Status
Tilbaketrukket
Intervensjon / Behandling
Detaljert beskrivelse
This is a prospective single arm study to evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
Studietype
Intervensjonell
Fase
- Fase 3
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Willing and able to provide informed consent and to participate in the study
- Age > or = 40 years at the time of the screening
- Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan
- Minimum of 2 subsegments appropriate for treatment
- MRCD questionnaire score of 2 or greater at screening
- Failure of medical therapy to provide relief of symptoms
Spirometry 15 minutes after administration of bronchodilator (BOTH):
- FEV1 < 50 % predicted.
- FEV1/FVC ratio <70 %
Lung volumes by plethysmography (BOTH):
- Total Lung Capacity (TLC) > 100 % predicted
- Residual Volume (RV) > 150 % predicted
- Diffusing Capacity of Carbon Monoxide(DLco) > = 20 and < = 60 percent predicted
- Oxygen saturation (SpO2) > 90 % on < or = 4 L/min supplemental O2, at rest
- Six-Minute Walk Test distance > or = 150 m
- Abstinence from smoking for at least 16 weeks prior to screening
Exclusion Criteria:
- Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation
- Requirement for ventilator support (invasive or non-invasive)
- Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit
Pulmonary hypertension, defined as:
- Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report
- If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg
- Clinically significant asthma (reversible airway obstruction) or bronchiectasis
CT scan: Presence of the following radiologic abnormalities:
- Pulmonary nodule on CT scan greater that 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET)
- Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
- Significant interstitial lung disease
- Significant pleural disease
- Giant bullous disease (a predominant bulla > 10 cm in all dimensions >1 / 3 of the hemithorax)
- Use of systemic steroids > 20 mg/day or equivalent, immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted)
- Allergy or sensitivity to medications required to safely undergo AeriSeal System treatment
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the screening visit
- 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
Significant comorbidity that carries prohibitive risks or is associated with less than 2-year expected survival, including any of the following:
- HIV/AIDS
- Active malignancy
- Stroke or Transient Ischemia Attack (TIA) within 12 months of screening
- Myocardial infarction within 12 months of screening
- Congestive heart failure within 12 months of screening defined at clinical evidence of right or left hear failure or left ventricular ejection fraction < 45 % on echocardiogram
- Any condition that the Investigator believes 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: AeriSeal Emphysematous Lung Sealant Syst
This is a prospective, open label, single-arm, multicenter, investigational study.
Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.
|
This is a prospective, open label, single-arm, multicenter, investigational study.
Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Volume change by CT
Tidsramme: 28 - 30 weeks
|
Group mean normalized change from baseline in the volume of the treated lung lobes measured by quantitative CT at 24 weeks post-treatment (defined as the sum of volume change in all treated lobes/number of treatments).
|
28 - 30 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fraction of patients showing clinically significant improvements from baseline in one or more of the following outcomes at 24 weeks post treatment: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Medical Research Council Dyspnea
Tidsramme: 28 - 30 weeks
|
Group mean change in baseline to week 24 in:Forced Expiratory Volume in 1 second (FEV1),Forced Vital Capacity (FVC),Medical Research Council Dyspnea (MRCD), 6 Six-Minute Walk Test (6MWT), Saint George Respiratory Questionnaire (SGRQ)
|
28 - 30 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Felix Herth, Prof. Dr med, Thoraxklinik am Uniklinikum Heidelberg
- Hovedetterforsker: Wolfgang Gesierich, Dr med, Asklepios Fachkliniken Muenchen - Gauting
- Hovedetterforsker: Manfred Wagner, Dr med, Klinikum Nuernberg Nord
- Hovedetterforsker: Mordechai Kramer, Prof, Rabin Medical Center
- Hovedetterforsker: Martin Hetzel, Dr med, Krankenhaus vom Roten Kreuz - Stuttgart
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Forventet)
1. november 2013
Studiet fullført (Faktiske)
1. november 2013
Datoer for studieregistrering
Først innsendt
18. juli 2013
Først innsendt som oppfylte QC-kriteriene
24. juli 2013
Først lagt ut (Anslag)
26. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. november 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. november 2013
Sist bekreftet
1. november 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 03-C13-001PLV
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