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
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): EP-101 via nebulizer (eFlow®) 25 ug; EP-101 via nebulizer (eFlow®) 50 ug; EP-101 via nebulizer (eFlow®) 100 ug; Placebo EP-101; Tiotropium bromide via (Spiriva® Handihaler®); Ipratropium bromide Inhalation Solution via Handihaler® DPI; EP-101 via nebulizer (eFlow®) 200 ug
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): EP-101 (25 ug ) Dose 1 administered once daily for 7 days; EP-101 (50 ug ) administered once daily for 7 days; EP-101 (100ug) administered once daily for 7 days; Placebo EP-101 administered once daily for 7 days; Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI; Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer; EP-101 (200) ug administered once daily for 7 days
Other intervention name(s): SUN101; SUN101; SUN101; Placebo; Tiotropium bromide; Ipratropium bromide; SUN101
Intervention MeSH terms: Bromides; Tiotropium Bromide; Ipratropium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD