Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 140
Healthy volunteers: no

Brief 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.

Arms:
arm 1: EP-101 via nebulizer (eFlow®) arm 2: Tiotropium bromide via (Spiriva® Handihaler®) arm 3: Ipratropium bromide Inhalation Solution via Handihaler® DPI arm 4: Placebo arm 5: EP-101 via nebulizer (eFlow®) arm 6: EP-101 via nebulizer (eFlow®) arm 7: EP-101 via nebulizer (eFlow®)

Interventions: intervention 1: EP-101 via nebulizer (eFlow®) 25 ug intervention 2: EP-101 via nebulizer (eFlow®) 50 ug intervention 3: EP-101 via nebulizer (eFlow®) 100 ug intervention 4: Placebo EP-101 intervention 5: Tiotropium bromide via (Spiriva® Handihaler®) intervention 6: Ipratropium bromide Inhalation Solution via Handihaler® DPI intervention 7: EP-101 via nebulizer (eFlow®) 200 ug
Intervention descriptions: intervention 1: EP-101 (25 ug ) Dose 1 administered once daily for 7 days intervention 2: EP-101 (50 ug ) administered once daily for 7 days intervention 3: EP-101 (100ug) administered once daily for 7 days intervention 4: Placebo EP-101 administered once daily for 7 days intervention 5: Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI intervention 6: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer intervention 7: EP-101 (200) ug administered once daily for 7 days

Protocol document: