NCT01426009

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

May 7, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

August 29, 2011

Results QC Date

January 2, 2018

Last Update Submit

May 8, 2018

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

  • Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)

    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

    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

Secondary Outcomes (5)

  • Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)

    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)

    Day 1 and Day 7

  • Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests

    Day 1 through Day 7

  • Rescue Medication Use

    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)

    Day 1 and Day 7

Study Arms (7)

EP-101 via nebulizer (eFlow®) 25 ug

EXPERIMENTAL

EP-101 via nebulizer (eFlow®)

Drug: EP-101 via nebulizer (eFlow®) 25 ug

Tiotropium bromide via (Spiriva® Handihaler®)

ACTIVE COMPARATOR

Tiotropium bromide via (Spiriva® Handihaler®)

Drug: Tiotropium bromide via (Spiriva® Handihaler®)

Ipratropium bromide Inhalation Solution

ACTIVE COMPARATOR

Ipratropium bromide Inhalation Solution via Handihaler® DPI

Drug: Ipratropium bromide Inhalation Solution via Handihaler® DPI

Placebo EP-101

PLACEBO COMPARATOR

Placebo

Drug: Placebo EP-101

EP-101 via nebulizer (eFlow®) 50 ug

EXPERIMENTAL

EP-101 via nebulizer (eFlow®)

Drug: EP-101 via nebulizer (eFlow®) 50 ug

EP-101 via nebulizer (eFlow®) 100 ug

EXPERIMENTAL

EP-101 via nebulizer (eFlow®)

Drug: EP-101 via nebulizer (eFlow®) 100 ug

EP-101 via nebulizer (eFlow®) 200 ug

EXPERIMENTAL

EP-101 via nebulizer (eFlow®)

Drug: EP-101 via nebulizer (eFlow®) 200 ug

Interventions

EP-101 via nebulizer (eFlow®) 25 ugDRUG

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

Also known as: SUN101
EP-101 via nebulizer (eFlow®) 25 ug
EP-101 via nebulizer (eFlow®) 50 ugDRUG

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

Also known as: SUN101
EP-101 via nebulizer (eFlow®) 50 ug
EP-101 via nebulizer (eFlow®) 100 ugDRUG

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

Also known as: SUN101
EP-101 via nebulizer (eFlow®) 100 ug
Placebo EP-101DRUG

Placebo EP-101 administered once daily for 7 days

Also known as: Placebo
Placebo EP-101
Tiotropium bromide via (Spiriva® Handihaler®)DRUG

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

Also known as: Tiotropium bromide
Tiotropium bromide via (Spiriva® Handihaler®)
Ipratropium bromide Inhalation Solution via Handihaler® DPIDRUG

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

Also known as: Ipratropium bromide
Ipratropium bromide Inhalation Solution
EP-101 via nebulizer (eFlow®) 200 ugDRUG

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

Also known as: SUN101
EP-101 via nebulizer (eFlow®) 200 ug

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Elevation Investigational Site

Phoenix, Arizona, 85006, United States

Location

Elevation Investigational Site

Los Angeles, California, 90048, United States

Location

Elevation Investigational Site

DeLand, Florida, 32720, United States

Location

Elevation Investigational SIte

Madisonville, Kentucky, 42431, United States

Location

Elevation Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

Elevation Investigational Site

Charlotte, North Carolina, 28207, United States

Location

Elevation Investigational Site

Raleigh, North Carolina, 27607, United States

Location

Elevation Investigational Site

Medford, Oregon, 97504, United States

Location

Elevation Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

Elevation Investigational Site

Tacoma, Washington, 98418, United States

Location

Elevation Investigational Site

Manchester, M21 8AD, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium BromideIpratropium

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingAtropine DerivativesBelladonna AlkaloidsSolanaceous Alkaloids

Results Point of Contact

Title
Respiratory Medical Director
Organization
Sunovion Pharmaceuticals Inc.
1-866-503-6351

Study Officials

  • Ahmet Tutuncu, M.D., Ph.D.

    Chief Medical Officer / Elevation Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2011

First Posted

August 30, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 9, 2018

Results First Posted

May 7, 2018

Record last verified: 2018-05

Locations

US(10)GB(1)