Chronic Obstructive Pulmonary DiseasePhase 2NCT02948582

Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing Glycopyrrolate Inhalation Solution12.5μg, Glycopyrrolate Inhalation Solution 50μg and Glycopyrrolate Inhalation Solution 100μg in people with Chronic Obstructive Pulmonary Disease, run by Sunovion Respiratory Development Inc..

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

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Glycopyrrolate Inhalation Solution12.5μg, Glycopyrrolate Inhalation Solution 50μg and Glycopyrrolate Inhalation Solution 100μg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: No sites listed yet
Study dates: Jul 2010to Nov 2010
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients aged 40 through 75 years, inclusive
A clinical diagnosis of COPD according to the GOLD guidelines
Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10
Post-bronchodilator FEV1 30-70% of predicted normal at the Screening Visit
Post-bronchodilator FEV1/FVC ratio < 0.70 at the Screening Visit
Improvement in FEV1 >12% and 150 mL following inhalation of ipratropium bromide at the Screening Visit

Show all 9Show fewer

Ability to perform reproducible spirometry according to the ATS/ERS guidelines
Willing to stay at the study site for approximately 30 hours on each treatment visit
Willing and able to provide written informed consent

Who cannot join

Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
Abstinence
Post-menopausal for at least two years
Surgically sterile (i.e., tubal ligation, hysterectomy)
Oral contraceptives (taken for at least one month prior to the Screening Visit)
Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent)

Show all 28Show fewer

Barrier methods (e.g., condoms with spermicide)
Intrauterine device (i.e., IUD)
Vasectomy of male partner
Non-heterosexual life style
Current evidence or recent history of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities
Recent history of hospitalization due to an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit
Primary diagnosis of asthma
Prior lung volume reduction surgery or history of chest/lung irradiation
Regular use of daily oxygen therapy
Use of systemic (eg, intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
Respiratory tract infection within 6 weeks prior to the Screening Visit
History of tuberculosis, bronchiectasis or other non- specific pulmonary disease
History of urinary retention or bladder neck obstruction type symptoms
History of narrow-angle glaucoma
Clinically significant abnormal ECG
Positive Hepatitis B surface antigen or positive Hepatitis C antibody
Positive screening test for HIV antibodies
Current or recent history (previous 12 months) of excessive use or abuse of alcohol
Current evidence or history of abusing legal drugs or use of illegal drugs or substances
Donation of 450 mL of blood within 8 weeks of the Screening Visit
History of hypersensitivity or intolerance to aerosol medications
Participation in another investigational drug study was received within 30 days prior to the Screening Visit

About this study

Official title: Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebuliser in Patients With COPD

The study assessed the safety and ability of an orally inhaled medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24 hours and blood was collected to measure how much GIS was in the bloodstream. The study was conducted to find the once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow nebulizer.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Glycopyrrolate Inhalation Solution12.5μg, Glycopyrrolate Inhalation Solution 50μg, Glycopyrrolate Inhalation Solution 100μg, Glycopyrrolate Inhalation Solution 200μg, Glycopyrrolate Inhalation Solution 400μg
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Emphysema, Chronic bronchitis
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic

What participants receive

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

Glycopyrrolate Inhalation Solution12.5μgDrug
Also called GIS
Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily
Glycopyrrolate Inhalation Solution 50μgDrug
Also called GIS
Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily
Glycopyrrolate Inhalation Solution 100μgDrug
Also called GIS
Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily
Glycopyrrolate Inhalation Solution 200μgDrug
Also called GIS
Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily
Glycopyrrolate Inhalation Solution 400μgDrug
Also called GIS
Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily
Placebo 0.5mLDrug
Also called Placebo
Placebo 0.5mL via eFlow, once daily

Study groups in NCT02948582
Study group	Role	What they receive
Glycopyrrolate Inhalation Solution12.5μg	Experimental	Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution12.5μg
Glycopyrrolate Inhalation Solution 50μg	Experimental	Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 50μg
Glycopyrrolate Inhalation Solution 100μg	Experimental	Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 100μg
Glycopyrrolate Inhalation Solution 200μg	Experimental	Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 200μg
Glycopyrrolate Inhalation Solution 400μg	Experimental	Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 400μg
Placebo 0.5mL	Placebo comparator	Placebo 0.5mL via e-flow nebulizer, once daily Receives: Drug: Placebo 0.5mL

What is being measured

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

Trough FEV1 (Change From Baseline)
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Trough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit.
Measured: 24hr post dose
Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline).
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1.
Measured: 0-12h post dose
Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline).
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1.
Measured: 12-24h post dose
Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline)
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1.
Measured: 0 to 24h
Peak FEV1 (Change From Baseline and Percent Change)
spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1.
Measured: 0-4h post dose

Secondary outcomes (10)

Cmax; Maximum Observed Plasma Concentration
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hour
Tmax; Time to Maximum Observed Plasma Concentration
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hours
t1/2; Plasma Half-life
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hour
AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hour
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hour
Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Measured: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
Vital signs were measured at screening and at each Treatment Visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.
Measured: 0-24 h
Number of Clinically Significant Abnormal Laboratory Results Reported During the Study
Clinical safety lab parameters were collected at screening and at the post study assessment. Any laboratory values that were out of range of normal reference values were evaluated by the Investigators.
Measured: Day -14, Day 69
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
ECGs were recorded at screening and at each study treatment visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.
Measured: 0 to 24h
Percentage of Subjects With Treatment Emergent AEs
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Measured: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)

Timeline

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

Jul 2010Nov 2010

First posted28 Oct 2016 (estimated)
Study startJul 2010
Primary completionNov 2010
Study completionNov 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02948582
Sponsor's protocol ID: EP-101-02
Other IDs: 2010-018987-17
Status last verified: Mar 2018
First submitted: 26 Oct 2016
Last updated: 12 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Leaker BR, Barnes PJ, Jones CR, Tutuncu A, Singh D. Efficacy and safety of nebulized glycopyrrolate for administration using a high efficiency nebulizer in patients with chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2015 Mar;79(3):492-500. doi: 10.1111/bcp.12517.
PubMed 25243340

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebuliser in Patients With COPD
ClinicalTrials.gov ID: NCT02948582
Acronym / sponsor ID: EP-101-02
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Emphysema, Chronic bronchitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Sunovion Respiratory Development Inc.Industry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 28 Oct 2016 (estimated)
Results: Posted 12 Mar 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Glycopyrrolate Inhalation Solution12.5μg	Experimental	Drug: Glycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily
Glycopyrrolate Inhalation Solution 50μg	Experimental	Drug: Glycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily
Glycopyrrolate Inhalation Solution 100μg	Experimental	Drug: Glycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200μg	Experimental	Drug: Glycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily
Glycopyrrolate Inhalation Solution 400μg	Experimental	Drug: Glycopyrrolate Inhalation Solution 400μgGlycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily
Placebo 0.5mL	Placebo comparator	Drug: Placebo 0.5mLPlacebo 0.5mL via e-flow nebulizer, once daily

Who may qualify

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

Key inclusion criteria (9 listed)

Male and female patients aged 40 through 75 years, inclusive
A clinical diagnosis of COPD according to the GOLD guidelines
Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10
Post-bronchodilator FEV1 30-70% of predicted normal at the Screening Visit
Post-bronchodilator FEV1/FVC ratio < 0.70 at the Screening Visit

Key exclusion criteria (28 listed)

Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
Current evidence or recent history of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities
Recent history of hospitalization due to an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit
Primary diagnosis of asthma
Prior lung volume reduction surgery or history of chest/lung irradiation

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
Glycopyrrolate Inhalation Solution12.5μgAlso: GISGlycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Drug	Glycopyrrolate Inhalation Solution12.5μg
Glycopyrrolate Inhalation Solution 50μgAlso: GISGlycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Drug	Glycopyrrolate Inhalation Solution 50μg
Glycopyrrolate Inhalation Solution 100μgAlso: GISGlycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Drug	Glycopyrrolate Inhalation Solution 100μg
Glycopyrrolate Inhalation Solution 200μgAlso: GISGlycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Drug	Glycopyrrolate Inhalation Solution 200μg
Glycopyrrolate Inhalation Solution 400μgAlso: GISGlycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Drug	Glycopyrrolate Inhalation Solution 400μg
Placebo 0.5mLAlso: PlaceboPlacebo 0.5mL via eFlow, once daily	Drug	Placebo 0.5mL

Primary outcome

Trough FEV1 (Change From Baseline)
Time frame: 24hr post dose
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit.
Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline).
Time frame: 0-12h post dose
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1.
Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline).
Time frame: 12-24h post dose
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1.
Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline)
Time frame: 0 to 24h
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1.
Peak FEV1 (Change From Baseline and Percent Change)
Time frame: 0-4h post dose
spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1.

10 secondary outcomes

Cmax; Maximum Observed Plasma Concentration
Time frame: 0 to 12 hour
Tmax; Time to Maximum Observed Plasma Concentration
Time frame: 0 to 12 hours
t1/2; Plasma Half-life
Time frame: 0 to 12 hour
AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.
Time frame: 0 to 12 hour
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
Time frame: 0 to 12 hour
Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE
Time frame: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
Time frame: 0-24 h
Number of Clinically Significant Abnormal Laboratory Results Reported During the Study
Time frame: Day -14, Day 69
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
Time frame: 0 to 24h
Percentage of Subjects With Treatment Emergent AEs
Time frame: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)

Results and safety

Results posted to the registry on 12 Mar 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
Treatment Group 1	7	7
Treatment Group 2	7	7
Treatment Group 3	7	7
Treatment Group 4	7	7
Treatment Group 5	7	7
Treatment Group 6	7	7

Primary outcome: Trough FEV1 (Change From Baseline)

Time frame: 24hr post dose. Mean (Standard Deviation). Unit: liters

Measure	Glycopyrrolate Inhalation Solution12.5μg n = 38	Glycopyrrolate Inhalation Solution 50μg n = 38	Glycopyrrolate Inhalation Solution 100μg n = 37	Glycopyrrolate Inhalation Solution 200μg n = 37	Glycopyrrolate Inhalation Solution 400μg n = 37	Placebo 0.5mL n = 37
Value	-0.093 (0.1189)	0.0114 (0.1308)	0.0447 (0.1548)	0.0542 (0.1779)	0.0292 (0.1468)	-0.0612 (0.1233)

Glycopyrrolate Inhalation Solution12.5μg vs Placebo 0.5mL: least squares mean: 0.033 (95% CI -0.009 to 0.075), p = 0.1257, least squares mean
Glycopyrrolate Inhalation Solution 50μg vs Placebo 0.5mL: least squares mean: 0.072 (95% CI 0.030 to 0.113), p = 0.0008, least squares mean
Glycopyrrolate Inhalation Solution 100μg vs Placebo 0.5mL: least squares mean: 0.102 (95% CI 0.061 to 0.144), p <0.0001, least squares mean

Population analysed: All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent-to-treat analysis.

Primary outcome: Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline).

Time frame: 0-12h post dose. Mean (Standard Deviation). Unit: liters

Measure	Glycopyrrolate Inhalation Solution12.5μg n = 39	Glycopyrrolate Inhalation Solution 50μg n = 38	Glycopyrrolate Inhalation Solution 100μg n = 37	Glycopyrrolate Inhalation Solution 200μg n = 37	Glycopyrrolate Inhalation Solution 400μg n = 37	Placebo 0.5mL n = 37
actual standardized FEV1 AUC0_12	1.259 (0.409)	1.311 (0.422)	1.335 (0.394)	1.374 (0.391)	1.390 (0.423)	1.180 (0.427)
change from baseline standardized FEV1 AUC0_12	0.055 (0.113)	0.126 (0.112)	0.136 (0.134)	0.184 (0.134)	0.170 (0.110)	-0.024 (0.095)

Glycopyrrolate Inhalation Solution12.5μg vs Placebo 0.5mL: least squares mean: 0.086 (95% CI 0.050 to 0.123), p <0.0001, least squares mean
Glycopyrrolate Inhalation Solution 50μg vs Placebo 0.5mL: least squares mean: 0.151 (95% CI 0.114 to 0.187), p <0.0001, least squares mean
Glycopyrrolate Inhalation Solution 100μg vs Placebo 0.5mL: least squares mean: 0.156 (95% CI 0.120 to 0.193), p <0.0001, least squares mean

Population analysed: All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis

Primary outcome: Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline).

Time frame: 12-24h post dose. Mean (Standard Deviation). Unit: liters

Measure	Glycopyrrolate Inhalation Solution12.5μg n = 39	Glycopyrrolate Inhalation Solution 50μg n = 38	Glycopyrrolate Inhalation Solution 100μg n = 37	Glycopyrrolate Inhalation Solution 200μg n = 37	Glycopyrrolate Inhalation Solution 400μg n = 37	Placebo 0.5mL n = 37
acutal standardized FEV1 AUC0_12	1.165 (0.377)	1.203 (0.404)	1.227 (0.369)	1.253 (0.346)	1.259 (0.396)	1.123 (0.392)
change from baseline standardized FEV1 AUC0_12	-0.038 (0.132)	0.018 (0.135)	0.028 (0.138)	0.063 (0.178)	0.039 (0.135)	-0.082 (0.120)

Glycopyrrolate Inhalation Solution12.5μg vs Placebo 0.5mL: least squares mean: 0.058 (95% CI 0.021 to 0.095), p = 0.0028, least squares mean
Placebo 0.5mL: least squares mean: 0.100 (95% CI 0.063 to 0.137), p <0.0001, least squares mena
Glycopyrrolate Inhalation Solution 100μg vs Placebo 0.5mL: least squares mean: 0.105 (95% CI 0.068 to 0.142), p <0.0001, least squares mean

Population analysed: All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis

Primary outcome: Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline)

Time frame: 0 to 24h. Mean (Standard Deviation). Unit: liters

Measure	Glycopyrrolate Inhalation Solution12.5μg n = 39	Glycopyrrolate Inhalation Solution 50μg n = 38	Glycopyrrolate Inhalation Solution 100μg n = 37	Glycopyrrolate Inhalation Solution 200μg n = 37	Glycopyrrolate Inhalation Solution 400μg n = 37	Placebo 0.5mL n = 37
Actual standardized FEV1 AUC0_12	1.212 (0.391)	1.257 (0.411)	1.281 (0.379)	1.313 (0.364)	1.325 (0.407)	1.151 (0.408)
change from baseline standardized FEV1 AUC0_12	0.009 (0.114)	0.072 (0.115)	0.082 (0.128)	0.123 (0.146)	0.105 (0.113)	-0.053 (0.102)

Population analysed: all subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 0-69 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glycopyrrolate Inhalation Solution12.5μg	0 of 39 (0%)	13 of 39 (33.3%)	Not reported
Glycopyrrolate Inhalation Solution 50μg	0 of 38 (0%)	9 of 38 (23.7%)	Not reported
Glycopyrrolate Inhalation Solution 100μg	1 of 37 (2.7%)	10 of 37 (27%)	Not reported
Glycopyrrolate Inhalation Solution 200μg	0 of 37 (0%)	10 of 37 (27%)	Not reported
Glycopyrrolate Inhalation Solution 400μg	0 of 37 (0%)	10 of 37 (27%)	Not reported
Placebo 0.5mL	0 of 37 (0%)	10 of 37 (27%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25243340Leaker BR, Barnes PJ, Jones CR, Tutuncu A, Singh D. Efficacy and safety of nebulized glycopyrrolate for administration using a high efficiency nebulizer in patients with chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2015 Mar;79(3):492-500. doi: 10.1111/bcp.12517.

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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, MD, PhD study chair

Elevation Pharmaceuticals, Inc., (now known as Sunovion Respriatory Developement Inc.)

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 9 inclusion and 28 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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 12 Mar 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?

Trough FEV1 (Change From Baseline) (time frame: 24hr post dose). The study lists 5 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 NCT02948582, which also lists 1 linked publication.

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 12 Mar 2018.