Chronic Obstructive Pulmonary DiseasePhase 2NCT01426009

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

A Phase 2 study testing EP-101 via nebulizer (eFlow®) 25 ug, EP-101 via nebulizer (eFlow®) 50 ug and EP-101 via nebulizer (eFlow®) 100 ug in people with Chronic Obstructive Pulmonary Disease, run by Sunovion Respiratory Development Inc. at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: EP-101 via nebulizer (eFlow®) 25 ug, EP-101 via nebulizer (eFlow®) 50 ug and EP-101 via nebulizer (eFlow®) 100 ug
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 11 sitesin 2 countries
Study dates: Aug 2011to Dec 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States10 sites

Elevation Investigational Site
Charlotte, North Carolina, 28207
Elevation Investigational Site
DeLand, Florida, 32720
Elevation Investigational Site
Los Angeles, California, 90048
Elevation Investigational SIte
Madisonville, Kentucky, 42431
Elevation Investigational Site
Medford, Oregon, 97504
Elevation Investigational Site
North Dartmouth, Massachusetts, 02747
Elevation Investigational Site
Phoenix, Arizona, 85006
Elevation Investigational Site
Raleigh, North Carolina, 27607
Elevation Investigational Site
Spartanburg, South Carolina, 29303
Elevation Investigational Site
Tacoma, Washington, 98418

Other trials in United States

United Kingdom1 site

Elevation Investigational Site
Manchester, M21 8AD

Other trials in United Kingdom

About this study

Official title: 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

Read the 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.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: 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®)
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EP-101 via nebulizer (eFlow®) 25 ugDrug
Also called SUN101
EP-101 (25 ug ) Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®) 50 ugDrug
Also called SUN101
EP-101 (50 ug ) administered once daily for 7 days
EP-101 via nebulizer (eFlow®) 100 ugDrug
Also called SUN101
EP-101 (100ug) administered once daily for 7 days
Placebo EP-101Drug
Also called Placebo
Placebo EP-101 administered once daily for 7 days
Tiotropium bromide via (Spiriva® Handihaler®)Drug
Also called Tiotropium bromide
Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPIDrug
Also called Ipratropium bromide
Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
EP-101 via nebulizer (eFlow®) 200 ugDrug
Also called SUN101
EP-101 (200) ug administered once daily for 7 days

Study groups in NCT01426009
Study group	Role	What they receive
EP-101 via nebulizer (eFlow®) 25 ug	Experimental	EP-101 via nebulizer (eFlow®) Receives: Drug: EP-101 via nebulizer (eFlow®) 25 ug
Tiotropium bromide via (Spiriva® Handihaler®)	Active comparator	Tiotropium bromide via (Spiriva® Handihaler®) Receives: Drug: Tiotropium bromide via (Spiriva® Handihaler®)
Ipratropium bromide Inhalation Solution	Active comparator	Ipratropium bromide Inhalation Solution via Handihaler® DPI Receives: Drug: Ipratropium bromide Inhalation Solution via Handihaler® DPI
Placebo EP-101	Placebo comparator	Placebo Receives: Drug: Placebo EP-101
EP-101 via nebulizer (eFlow®) 50 ug	Experimental	EP-101 via nebulizer (eFlow®) Receives: Drug: EP-101 via nebulizer (eFlow®) 50 ug
EP-101 via nebulizer (eFlow®) 100 ug	Experimental	EP-101 via nebulizer (eFlow®) Receives: Drug: EP-101 via nebulizer (eFlow®) 100 ug
EP-101 via nebulizer (eFlow®) 200 ug	Experimental	EP-101 via nebulizer (eFlow®) Receives: Drug: EP-101 via nebulizer (eFlow®) 200 ug

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines
Measured: 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)
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.
Measured: Day 1 and Day 7
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
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.
Measured: Day 1 through Day 7
Rescue Medication Use
Mean number of puffs of daily rescue medication
Measured: 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)
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.
Measured: Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Dec 2011

First posted30 Aug 2011 (estimated)
Study startAug 2011
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01426009
Sponsor's protocol ID: EP-101-03
Status last verified: May 2018
First submitted: 29 Aug 2011
Last updated: 9 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01426009
Acronym / sponsor ID: EP-101-03
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Sunovion Respiratory Development Inc.Industry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 30 Aug 2011 (estimated)
Results: Posted 7 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
EP-101 via nebulizer (eFlow®) 25 ug	Experimental	Drug: EP-101 via nebulizer (eFlow®) 25 ugEP-101 via nebulizer (eFlow®)
Tiotropium bromide via (Spiriva® Handihaler®)	Active comparator	Drug: Tiotropium bromide via (Spiriva® Handihaler®)Tiotropium bromide via (Spiriva® Handihaler®)
Ipratropium bromide Inhalation Solution	Active comparator	Drug: Ipratropium bromide Inhalation Solution via Handihaler® DPIIpratropium bromide Inhalation Solution via Handihaler® DPI
Placebo EP-101	Placebo comparator	Drug: Placebo EP-101Placebo
EP-101 via nebulizer (eFlow®) 50 ug	Experimental	Drug: EP-101 via nebulizer (eFlow®) 50 ugEP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®) 100 ug	Experimental	Drug: EP-101 via nebulizer (eFlow®) 100 ugEP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®) 200 ug	Experimental	Drug: EP-101 via nebulizer (eFlow®) 200 ugEP-101 via nebulizer (eFlow®)

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EP-101 via nebulizer (eFlow®) 25 ugAlso: SUN101EP-101 (25 ug ) Dose 1 administered once daily for 7 days	Drug	EP-101 via nebulizer (eFlow®) 25 ug
EP-101 via nebulizer (eFlow®) 50 ugAlso: SUN101EP-101 (50 ug ) administered once daily for 7 days	Drug	EP-101 via nebulizer (eFlow®) 50 ug
EP-101 via nebulizer (eFlow®) 100 ugAlso: SUN101EP-101 (100ug) administered once daily for 7 days	Drug	EP-101 via nebulizer (eFlow®) 100 ug
Placebo EP-101Also: PlaceboPlacebo EP-101 administered once daily for 7 days	Drug	Placebo EP-101
Tiotropium bromide via (Spiriva® Handihaler®)Also: Tiotropium bromideTiotropium 18 µg administered once daily for 7 days using Handihaler® DPI	Drug	Tiotropium bromide via (Spiriva® Handihaler®)
Ipratropium bromide Inhalation Solution via Handihaler® DPIAlso: Ipratropium bromideIpratropium 500 µg administered three times daily for 7 days using general purpose nebulizer	Drug	Ipratropium bromide Inhalation Solution
EP-101 via nebulizer (eFlow®) 200 ugAlso: SUN101EP-101 (200) ug administered once daily for 7 days	Drug	EP-101 via nebulizer (eFlow®) 200 ug

Primary outcome

Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 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.
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
Time frame: 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.

5 secondary outcomes

Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)
Time frame: 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)
Time frame: Day 1 and Day 7
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
Time frame: Day 1 through Day 7
Rescue Medication Use
Time frame: 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)
Time frame: Day 1 and Day 7

Results and safety

Results posted to the registry on 7 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total	139	137

Primary outcome: Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Day 1 and Day 7. Mean (Standard Deviation). Unit: liters

Measure	EP-101 Via Nebulizer (eFlow®) 25 mcg n = 72	EP-101 Via Nebulizer (eFlow®) 50 mcg n = 75	EP-101 Via Nebulizer (eFlow®)100 mcg n = 75	EP-101 Via Nebulizer (eFlow®) 200 mcg n = 75	Ipratropium Bromide Inhalation Solution n = 72	Tiotropium Bromide Via (Spiriva® Handihaler®) n = 76	Placebo n = 77
Trough FEV1 - day 1	0.0477 (0.16359)	0.1009 (0.13261)	0.0648 (0.14239)	0.0632 (0.14965)	0.0933 (0.18980)	0.0740 (0.144441)	0.0301 (0.14394)
Trough FEV1 - day 7	0.0478 (0.18965)	0.0699 (0.16909)	0.0666 (0.15132)	0.0840 (0.13842)	0.0292 (0.16507)	0.0564 (0.16356)	-0.155 (0.17934)

EP-101 Via Nebulizer (eFlow®) 25 mcg vs Placebo: Least Squares Mean Difference (SE): 0.0723 (95% CI 0.0347 to 0.1099), p = 0.0003, ANCOVA
EP-101 Via Nebulizer (eFlow®) 50 mcg vs Placebo: Least Squares Mean Difference (SE): 0.0676 (95% CI 0.0307 to 0.1046), p = 0.0006, ANCOVA
EP-101 Via Nebulizer (eFlow®)100 mcg vs Placebo: Least Squares Mean Difference (SE): 0.1021 (95% CI 0.0644 to 0.1398), p <0.0001, ANCOVA

Population analysed: All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent to treat analysis set

Primary outcome: Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7

Time frame: Day 1 and Day 7. Mean (Standard Deviation). Unit: liters

Measure	EP-101 Via Nebulizer (eFlow®) 25 mcg n = 72	EP-101 Via Nebulizer (eFlow®) 50 mcg n = 76	EP-101 Via Nebulizer (eFlow®)100 mcg n = 75	EP-101 Via Nebulizer (eFlow®) 200 mcg n = 71	Ipratropium Bromide Inhalation Solution n = 74	Tiotropium Bromide Via (Spiriva® Handihaler®) n = 75	Placebo n = 76
AUC 0-12 on Day 1	0.1001 (0.15704)	0.1520 (0.13646)	0.1414 (0.11045)	0.1720 (0.12644)	0.1990 (0.13740)	0.1213 (0.12548)	0.0130 (0.11486)
AUC 12-24 on Day 1	0.0039 (0.17104)	0.0681 (0.12835)	0.0413 (0.14032)	0.0645 (0.13275)	0.0987 (0.16958)	0.0499 (0.14532)	-0.0245 (0.12151)
AUC 0-24 on Day 1	0.0525 (0.15495)	0.1107 (0.12207)	0.0919 (0.11554)	0.1194 (0.11905)	0.1496 (0.14425)	0.0872 (0.12638)	-0.0073 (0.11377)
AUC 0-12 on Day 7	0.1034 (0.19035)	0.1411 (0.16343)	0.1329 (0.13416)	0.1438 (0.14833)	0.1603 (0.16420)	0.1256 (0.15197)	-0.0098 (0.15537)
AUC 12-24 on Day 7	0.0112 (0.18136)	0.0540 (0.16633)	0.0278 (0.15187)	0.0614 (0.13450)	0.0357 (0.17382)	0.0283 (0.15596)	0.0698 (0.16584)
AUC 0-24 on Day 7	0.0579 (0.17822)	0.0980 (0.15651)	0.0812 (0.13293)	0.1030 (0.13162)	0.1009 (0.15882)	0.0776 (0.14702)	-0.0395 (0.15415)

EP-101 Via Nebulizer (eFlow®) 25 mcg vs Placebo: Least Squares Mean Difference (SE): 0.0767 (95% CI 0.0505 to 0.1028), p <0.0001, ANCOVA
EP-101 Via Nebulizer (eFlow®) 50 mcg vs Placebo: Least Squares Mean Difference (SE): 0.1220 (95% CI 0.0965 to 0.1475), p <0.0001, ANCOVA
EP-101 Via Nebulizer (eFlow®)100 mcg vs Placebo: Least Squares Mean Difference (SE): 0.1222 (95% CI 0.0965 to 0.1479), p <0.0001, ANCOVA

Population analysed: All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent-to-treat (mITT) analysis set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: day 1 through day 7. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EP-101 Via Nebulizer (eFlow®) 25 mcg	8 of 74 (10.8%)	0 of 74 (0%)	0 of 74
EP-101 Via Nebulizer (eFlow®) 50 mcg	13 of 78 (16.7%)	0 of 78 (0%)	0 of 78
EP-101 Via Nebulizer (eFlow®)100 mcg	14 of 76 (18.4%)	0 of 76 (0%)	0 of 76
EP-101 Via Nebulizer (eFlow®) 200 mcg	13 of 75 (17.3%)	0 of 75 (0%)	0 of 75
Ipratropium Bromide Inhalation Solution	5 of 75 (6.7%)	0 of 75 (0%)	0 of 75
Tiotropium Bromide Via (Spiriva® Handihaler®)	2 of 76 (2.6%)	0 of 76 (0%)	0 of 76
Placebo	16 of 77 (20.8%)	0 of 77 (0%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ahmet Tutuncu, M.D., Ph.D. study director

Chief Medical Officer / Elevation Pharmaceuticals, Inc.

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1) (time frame: Day 1 and Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01426009.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.