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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 maj 2018 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

140

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: EP-101 via nebulizer (eFlow®) 25 ug
EP-101 via nebulizer (eFlow®)
Läkemedel: EP-101 via nebulizer (eFlow®) 25 ug
EP-101 (25 ug ) Dose 1 administered once daily for 7 days
Andra namn:
  • SUN101
Aktiv komparator: Tiotropium bromide via (Spiriva® Handihaler®)
Läkemedel: Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
Andra namn:
  • Tiotropiumbromid
Aktiv komparator: Ipratropium bromide Inhalation Solution
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Läkemedel: Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
Andra namn:
  • Ipratropium bromide
Placebo-jämförare: Placebo EP-101
Placebo
Läkemedel: Placebo EP-101
Placebo EP-101 administered once daily for 7 days
Andra namn:
  • Placebo
Experimentell: EP-101 via nebulizer (eFlow®) 50 ug
EP-101 via nebulizer (eFlow®)
Läkemedel: EP-101 via nebulizer (eFlow®) 50 ug
EP-101 (50 ug ) administered once daily for 7 days
Andra namn:
  • SUN101
Experimentell: EP-101 via nebulizer (eFlow®) 100 ug
EP-101 via nebulizer (eFlow®)
Läkemedel: EP-101 via nebulizer (eFlow®) 100 ug
EP-101 (100ug) administered once daily for 7 days
Andra namn:
  • SUN101
Experimentell: EP-101 via nebulizer (eFlow®) 200 ug
EP-101 via nebulizer (eFlow®)
Läkemedel: EP-101 via nebulizer (eFlow®) 200 ug
EP-101 (200) ug administered once daily for 7 days
Andra namn:
  • SUN101

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sunovion Respiratory Development Inc.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2011

Primärt slutförande (Faktisk)

1 december 2011

Avslutad studie (Faktisk)

1 december 2011

Studieregistreringsdatum

Först inskickad

29 augusti 2011

Först inskickad som uppfyllde QC-kriterierna

29 augusti 2011

Första postat (Uppskatta)

30 augusti 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 maj 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 maj 2018

Senast verifierad

1 maj 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • EP-101-03

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