A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)
6 febbraio 2018 aggiornato da: Sunovion Respiratory Development Inc.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of EP-101 (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease: GOLDEN-2 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)
This is a randomized, double-blind, placebo-controlled, parallel arm study.
The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a randomized, double-blind, placebo-controlled, parallel arm study.
The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo with respect to the change from baseline in morning trough FEV1 on Day 29.
Trough FEV1 is defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
275
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Alabama
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Jasper, Alabama, Stati Uniti, 35501
- Jasper Summit Research, LLC
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Pulmonary Associates, PA
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California
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Fullerton, California, Stati Uniti, 92835
- California Research Medical Group, Inc.
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Los Angeles, California, Stati Uniti, 90095
- UCLA David Geffen School of Medicine
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Riverside, California, Stati Uniti, 92506
- Integrated Research Group
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Sacramento, California, Stati Uniti, 95819
- Capital Allergy & Respiratory Disease Center
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San Diego, California, Stati Uniti, 92120
- Institute of HealthCare Assessment, Inc.
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Florida
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Clearwater, Florida, Stati Uniti, 33765
- Clinical Research of West Florida
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Tampa, Florida, Stati Uniti, 33603
- Clinical Research of West Florida
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Georgia
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Austell, Georgia, Stati Uniti, 30106
- Georgia Clinical Research
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Lawrenceville, Georgia, Stati Uniti, 30046
- Gwinnett Biomedical Research
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Kansas
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Topeka, Kansas, Stati Uniti, 66606
- Veritas Clinical Specialities, LTD
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55407
- Minnesota Lung Center
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28207
- American Health Research
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Raleigh, North Carolina, Stati Uniti, 27607
- North Carolina Clinical Research
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45242
- New Horizons Clinical Research
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Oregon
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Medford, Oregon, Stati Uniti, 97504
- Clinical Research Institute of Southern Oregon, PC
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Medford, Oregon, Stati Uniti, 97504
- Sunstone Medical Research LLC
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Portland, Oregon, Stati Uniti, 97202
- Allergy Associates Research Center
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29615
- Upstate Pharmaceutical Research
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Greenville, South Carolina, Stati Uniti, 29615
- Greenville Pharmaceutical Research, Inc
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Spartanburg, South Carolina, Stati Uniti, 29303
- South Carolina Pharmaceutical Research
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Union, South Carolina, Stati Uniti, 29379
- CU Pharmacuetical Research
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Texas
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Houston, Texas, Stati Uniti, 77030
- Baylor College of Medicine
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New Braunfels, Texas, Stati Uniti, 78130
- Central Texas Health Research
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Virginia
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Richmond, Virginia, Stati Uniti, 23225
- Pulmonary Associates of Richmond, Inc.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 35 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Male and female subjects age 35 through 75 years, inclusive.
- A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
- Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
- Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
- Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
- Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
- Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
- a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
- b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- c. Abstinence.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
- Current evidence or history of clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
- Concomitant pulmonary disease or primary diagnosis of asthma.
- History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin
- Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period.
- Use of daily oxygen therapy > 10 hours per day.
- Use of systemic steroids within 3 months prior to the Screening Period.
- Respiratory tract infection within 6 weeks prior to or during the Screening Period.
- History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
- History of urinary retention or bladder neck obstruction type symptoms.
- History of narrow-angle glaucoma.
- Prolonged QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
- Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
- History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
- Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
- Female subject who is pregnant or lactating
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
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EP-101 Placebo AM + EP-101 Placebo PM
Altri nomi:
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Sperimentale: EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
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EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Altri nomi:
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Sperimentale: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
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EP-101 25 mcg AM + EP-101 25 mcg PM
Altri nomi:
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Sperimentale: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
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EP-101 50 mcg AM + EP-101 50 mcg PM
Altri nomi:
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Sperimentale: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
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EP-101 100 mcg AM + EP-101 100 mcg PM
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Lasso di tempo: Baseline and Day 29
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e.
approximately 12 hrs after the previous evening dose).
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Baseline and Day 29
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Standardized Change From Baseline FEV1 AUC(0-12)
Lasso di tempo: Day 28
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
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Day 28
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The Standardized Change From Baseline FEV1 AUC(12-24)
Lasso di tempo: Day 28
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
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Day 28
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The Peak FEV1 Change From Baseline
Lasso di tempo: Day 28
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.
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Day 28
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The Number of Subjects With Treatment-emergent Adverse Events
Lasso di tempo: Baseline up to Day 28
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Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Number of Subjects With Treatment-emergent Serious Adverse Events
Lasso di tempo: Baseline up to Day 28
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Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Lasso di tempo: Baseline up to Day 28
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Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Adverse Events
Lasso di tempo: Baseline up to Day 28
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Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Serious Adverse Events
Lasso di tempo: Baseline up to Day 28
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Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Lasso di tempo: Baseline up to Day 28
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Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Respiratory Medical Director, MD, Sunovion Respiratory Development
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2012
Completamento primario (Effettivo)
1 aprile 2013
Completamento dello studio (Effettivo)
1 aprile 2013
Date di iscrizione allo studio
Primo inviato
10 ottobre 2012
Primo inviato che soddisfa i criteri di controllo qualità
10 ottobre 2012
Primo Inserito (Stima)
15 ottobre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 marzo 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 febbraio 2018
Ultimo verificato
1 febbraio 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EP-101-04 (SUN101)
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 .
Prove cliniche su BPCO
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Fraunhofer-Institute of Toxicology and Experimental...Institute for Pharmacology and Toxicology, RWTH AachenCompletatoVolontari sani | COPD GOLD da I a IV | Asma GINA da 1 a 4Germania