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Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study

8. mai 2018 oppdatert av: Sunovion Respiratory Development Inc.

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Seven Arm, Four-Period Cross-over, Incomplete Block Design, 7-Day Dosing Study to Assess the Dose-Response, Safety, and Efficacy of EP-101 (SUN101) in Subjects With Moderate to Severe COPD

The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, four-period, incomplete block design cross-over study using EP-101(SUN101) and open-label active controls (tiotropium bromide and ipratropium bromide). The study population will consist of subjects of 40-75 years of age with moderate to severe COPD. Approximately 133 subjects diagnosed with moderate to severe COPD will be enrolled in order to achieve minimum 105 subjects completing the study.

Following a run-in phase, each subject will be randomly assigned to one of 7 treatment sequences,(96 sequences when order of administration is considered), with each sequence comprised of four 7-day Treatment Periods. There will be a washout period of 7 days between each Treatment Period. Study visits will be conducted on Days 1 and 7 of each Treatment Period, with an overnight stay required in the clinic during these visits. A Final Study Visit will be conducted 7 days following the last study treatment.

During each Treatment Period, study treatments will be administered once daily (QD), except for ipratropium inhalation solution, which will be administered three times daily (TID). EP-101 (SUN101)active and placebo treatments will be administered using an investigational high-efficiency eFlow® nebulizer. Tiotropium bromide (Spiriva®) will be administered in an open-label manner via Handihaler® dry-powder inhaler (DPI). Ipratropium bromide inhalation solution will be administered in an open-label manner via general purpose nebulizer.

This study was previously posted by Elevation Pharmaceuticals, Inc. On September 5, 2012, Elevation was acquired by merger with Sunovion Pharmaceuticals Inc. ("Sunovion"), which resulted in Elevation becoming a direct wholly-owned subsidiary of Sunovion. In conjunction with this acquisition, the name of Elevation has been changed to Sunovion Respiratory Development Inc.

Studietype

Intervensjonell

Registrering (Faktiske)

140

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006
        • Elevation Investigational Site
    • California
      • Los Angeles, California, Forente stater, 90048
        • Elevation Investigational Site
    • Florida
      • DeLand, Florida, Forente stater, 32720
        • Elevation Investigational Site
    • Kentucky
      • Madisonville, Kentucky, Forente stater, 42431
        • Elevation Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, Forente stater, 02747
        • Elevation Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28207
        • Elevation Investigational Site
      • Raleigh, North Carolina, Forente stater, 27607
        • Elevation Investigational Site
    • Oregon
      • Medford, Oregon, Forente stater, 97504
        • Elevation Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, Forente stater, 29303
        • Elevation Investigational Site
    • Washington
      • Tacoma, Washington, Forente stater, 98418
        • Elevation Investigational Site
  • Storbritannia
      • Manchester, Storbritannia, M21 8AD
        • Elevation Investigational Site

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 til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 40-75 years of age
  • Clinical diagnosis of moderate to severe COPD
  • Current/ex-smokers with at least 10 pack-year smoking history
  • Post-bronchodilator FEV1 ≥ 30% and ≤ 70% predicted normal values
  • Post-bronchodilator FEV1/FVC ratio of ≤ 0.70
  • Post-bronchodilator improvement in FEV1 ≥ 12% and ≤ 30%, and a minimum of 100 mL
  • Willing and able to remain at the study site for at least 24 hours at each study visit
  • Signed written informed consent

Exclusion Criteria:

  • Current evidence or recent history of any clinically significant and unstable disease or abnormality (e.g., myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes)
  • Primary diagnosis of asthma
  • History of malignancy within the past 5 years
  • History of COPD exacerbation within 6 weeks of Screening
  • Daily oxygen therapy > 10 hours per day
  • Systemic steroids use within 6 weeks of Screening
  • Respiratory tract infection within 6 weeks of Screening
  • History of tuberculosis, bronchiectasis
  • History of urinary retention or bladder neck obstruction type symptoms
  • History of glaucoma
  • Prolonged QTc interval (>460msec) or history of long QT syndrome
  • Recent history of alcohol or drug abuse
  • Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable birth control methods
  • History of hypersensitivity or intolerance to aerosol medications
  • Participation in another investigational drug study within 30 days of Screening

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: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: EP-101 via nebulizer (eFlow®) 25 ug
EP-101 via nebulizer (eFlow®)
Legemiddel: EP-101 via nebulizer (eFlow®) 25 ug
EP-101 (25 ug ) Dose 1 administered once daily for 7 days
Andre navn:
  • SUN101
Aktiv komparator: Tiotropium bromide via (Spiriva® Handihaler®)
Legemiddel: Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
Andre navn:
  • Tiotropiumbromid
Aktiv komparator: Ipratropium bromide Inhalation Solution
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Legemiddel: Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
Andre navn:
  • Ipratropium bromide
Placebo komparator: Placebo EP-101
Placebo
Legemiddel: Placebo EP-101
Placebo EP-101 administered once daily for 7 days
Andre navn:
  • Placebo
Eksperimentell: EP-101 via nebulizer (eFlow®) 50 ug
EP-101 via nebulizer (eFlow®)
Legemiddel: EP-101 via nebulizer (eFlow®) 50 ug
EP-101 (50 ug ) administered once daily for 7 days
Andre navn:
  • SUN101
Eksperimentell: EP-101 via nebulizer (eFlow®) 100 ug
EP-101 via nebulizer (eFlow®)
Legemiddel: EP-101 via nebulizer (eFlow®) 100 ug
EP-101 (100ug) administered once daily for 7 days
Andre navn:
  • SUN101
Eksperimentell: EP-101 via nebulizer (eFlow®) 200 ug
EP-101 via nebulizer (eFlow®)
Legemiddel: EP-101 via nebulizer (eFlow®) 200 ug
EP-101 (200) ug administered once daily for 7 days
Andre navn:
  • SUN101

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: Day 1 and Day 7
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 post dose for Day 1 and Day 7 within each Treatment Period. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period. Change from baseline was calculated as the trough FEV1 value minus the baseline for Day 1 and Day 7.
Day 1 and Day 7
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
Tidsramme: Day 1 and Day 7
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized FEV1 AUC(0-12hr and 12-24hr) on Day 1 and Day 7 was calculated using the trapezoidal rule from the changes in FEV1 at Day 1 and Day 7, respectively, from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval.
Day 1 and Day 7

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)
Tidsramme: Day 1 and Day 7
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines
Day 1 and Day 7
Treatment Responders (Number of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)
Tidsramme: Day 1 and Day 7
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Clinically meaningful is defined as when the change from baseline (mean of the two pre-dose values at Day 1) in 24 hour trough FEV1 on a SUN-101 treatment is more than 100 mL compared to the mean change in trough FEV1 from all subjects on the placebo treatment.
Day 1 and Day 7
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
Tidsramme: Day 1 through Day 7
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. Vital signs were performed during the screening period to confirm study eligibility and at the final study visit. ECGs were performed during the screening period to confirm study eligibility. Vital signs and ECG were additionally collected within 30 minutes pre-dose; and 30 minutes, and 1, 2, 4, 6, 12 hours, and 23 hours 45 minutes post-dose within each treatment period. Clinical laboratory assessments were conducted during the screening period, at each study visit during each treatment period, and at the final study visit.
Day 1 through Day 7
Rescue Medication Use
Tidsramme: Day 1 through Day 7
Mean number of puffs of daily rescue medication
Day 1 through Day 7
Treatment Responders (Percentage of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)
Tidsramme: Day 1 and Day 7
percentage of subjects with clinically meaningful change from pre-dose in trough FEV1 on Day 1 and Day 7 Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 1 and Day 7

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sunovion Respiratory Development Inc.

Etterforskere

  • Studieleder: Ahmet Tutuncu, M.D., Ph.D., Chief Medical Officer / Elevation Pharmaceuticals, Inc.

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. august 2011

Primær fullføring (Faktiske)

1. desember 2011

Studiet fullført (Faktiske)

1. desember 2011

Datoer for studieregistrering

Først innsendt

29. august 2011

Først innsendt som oppfylte QC-kriteriene

29. august 2011

Først lagt ut (Anslag)

30. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EP-101-03

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