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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01908933
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Fase
- Fase 3
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Volume change by CT
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Felix Herth, Prof. Dr med, Thoraxklinik am Uniklinikum Heidelberg
- Investigatore principale: Wolfgang Gesierich, Dr med, Asklepios Fachkliniken Muenchen - Gauting
- Investigatore principale: Manfred Wagner, Dr med, Klinikum Nuernberg Nord
- Investigatore principale: Mordechai Kramer, Prof, Rabin Medical Center
- Investigatore principale: Martin Hetzel, Dr med, Krankenhaus vom Roten Kreuz - Stuttgart
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 03-C13-001PLV
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .