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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

NCT ID: NCT01426009

Last Updated: 2018-05-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EP-101 via nebulizer (eFlow®) 25 ug

EP-101 via nebulizer (eFlow®)

Group Type EXPERIMENTAL

EP-101 via nebulizer (eFlow®) 25 ug

Intervention Type DRUG

EP-101 (25 ug ) Dose 1 administered once daily for 7 days

Tiotropium bromide via (Spiriva® Handihaler®)

Tiotropium bromide via (Spiriva® Handihaler®)

Group Type ACTIVE_COMPARATOR

Tiotropium bromide via (Spiriva® Handihaler®)

Intervention Type DRUG

Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI

Ipratropium bromide Inhalation Solution

Ipratropium bromide Inhalation Solution via Handihaler® DPI

Group Type ACTIVE_COMPARATOR

Ipratropium bromide Inhalation Solution via Handihaler® DPI

Intervention Type DRUG

Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer

Placebo EP-101

Placebo

Group Type PLACEBO_COMPARATOR

Placebo EP-101

Intervention Type DRUG

Placebo EP-101 administered once daily for 7 days

EP-101 via nebulizer (eFlow®) 50 ug

EP-101 via nebulizer (eFlow®)

Group Type EXPERIMENTAL

EP-101 via nebulizer (eFlow®) 50 ug

Intervention Type DRUG

EP-101 (50 ug ) administered once daily for 7 days

EP-101 via nebulizer (eFlow®) 100 ug

EP-101 via nebulizer (eFlow®)

Group Type EXPERIMENTAL

EP-101 via nebulizer (eFlow®) 100 ug

Intervention Type DRUG

EP-101 (100ug) administered once daily for 7 days

EP-101 via nebulizer (eFlow®) 200 ug

EP-101 via nebulizer (eFlow®)

Group Type EXPERIMENTAL

EP-101 via nebulizer (eFlow®) 200 ug

Intervention Type DRUG

EP-101 (200) ug administered once daily for 7 days

Interventions

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EP-101 via nebulizer (eFlow®) 25 ug

EP-101 (25 ug ) Dose 1 administered once daily for 7 days

Intervention Type DRUG

EP-101 via nebulizer (eFlow®) 50 ug

EP-101 (50 ug ) administered once daily for 7 days

Intervention Type DRUG

EP-101 via nebulizer (eFlow®) 100 ug

EP-101 (100ug) administered once daily for 7 days

Intervention Type DRUG

Placebo EP-101

Placebo EP-101 administered once daily for 7 days

Intervention Type DRUG

Tiotropium bromide via (Spiriva® Handihaler®)

Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI

Intervention Type DRUG

Ipratropium bromide Inhalation Solution via Handihaler® DPI

Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer

Intervention Type DRUG

EP-101 via nebulizer (eFlow®) 200 ug

EP-101 (200) ug administered once daily for 7 days

Intervention Type DRUG

Other Intervention Names

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SUN101 SUN101 SUN101 Placebo Tiotropium bromide Ipratropium bromide SUN101

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunovion Respiratory Development Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmet Tutuncu, M.D., Ph.D.

Role: STUDY_DIRECTOR

Chief Medical Officer / Elevation Pharmaceuticals, Inc.

Locations

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Elevation Investigational Site

Phoenix, Arizona, United States

Site Status

Elevation Investigational Site

Los Angeles, California, United States

Site Status

Elevation Investigational Site

DeLand, Florida, United States

Site Status

Elevation Investigational SIte

Madisonville, Kentucky, United States

Site Status

Elevation Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

Elevation Investigational Site

Charlotte, North Carolina, United States

Site Status

Elevation Investigational Site

Raleigh, North Carolina, United States

Site Status

Elevation Investigational Site

Medford, Oregon, United States

Site Status

Elevation Investigational Site

Spartanburg, South Carolina, United States

Site Status

Elevation Investigational Site

Tacoma, Washington, United States

Site Status

Elevation Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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EP-101-03

Identifier Type: -

Identifier Source: org_study_id

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