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CompletedNCT02948582Updated Mar 12, 2018Results posted

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 interventional study of Glycopyrrolate Inhalation Solution12.5μg and Glycopyrrolate Inhalation Solution 50μg in Chronic Obstructive Pulmonary Disease, sponsored by Sunovion Respiratory Development Inc.. Completed. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-12.

Sponsored by Sunovion Respiratory Development Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
40 Years to 75 Years
01

Study summary

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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Chronic Obstructive Pulmonary Disease
  • COPD
  • Emphysema
  • Chronic bronchitis
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 42 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Sunovion Respiratory Development Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Accepts healthy volunteers
No

Inclusion criteria

  1. Male and female patients aged 40 through 75 years, inclusive
  2. A clinical diagnosis of COPD according to the GOLD guidelines
  3. Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10
  4. Post-bronchodilator FEV1 30-70% of predicted normal at the Screening Visit
  5. Post-bronchodilator FEV1/FVC ratio \< 0.70 at the Screening Visit
  6. Improvement in FEV1 >12% and 150 mL following inhalation of ipratropium bromide at the Screening Visit
  7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines
  8. Willing to stay at the study site for approximately 30 hours on each treatment visit
  9. Willing and able to provide written informed consent

Exclusion criteria

Exclusion Criteria:

  1. 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)
    • Barrier methods (e.g., condoms with spermicide)
    • Intrauterine device (i.e., IUD)
    • Vasectomy of male partner
    • Non-heterosexual life style
  2. 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
  3. 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
  4. Primary diagnosis of asthma
  5. Prior lung volume reduction surgery or history of chest/lung irradiation
  6. Regular use of daily oxygen therapy
  7. Use of systemic (eg, intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
  8. Respiratory tract infection within 6 weeks prior to the Screening Visit
  9. History of tuberculosis, bronchiectasis or other non- specific pulmonary disease
  10. History of urinary retention or bladder neck obstruction type symptoms
  11. History of narrow-angle glaucoma
  12. Clinically significant abnormal ECG
  13. Positive Hepatitis B surface antigen or positive Hepatitis C antibody
  14. Positive screening test for HIV antibodies
  15. Current or recent history (previous 12 months) of excessive use or abuse of alcohol
  16. Current evidence or history of abusing legal drugs or use of illegal drugs or substances
  17. Donation of 450 mL of blood within 8 weeks of the Screening Visit
  18. History of hypersensitivity or intolerance to aerosol medications
  19. Participation in another investigational drug study was received within 30 days prior to the Screening Visit
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Glycopyrrolate Inhalation Solution12.5μg

    Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

    Drug: Glycopyrrolate Inhalation Solution12.5μg

  • Experimental
    Glycopyrrolate Inhalation Solution 50μg

    Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

    Drug: Glycopyrrolate Inhalation Solution 50μg

  • Experimental
    Glycopyrrolate Inhalation Solution 100μg

    Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

    Drug: Glycopyrrolate Inhalation Solution 100μg

  • Experimental
    Glycopyrrolate Inhalation Solution 200μg

    Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

    Drug: Glycopyrrolate Inhalation Solution 200μg

  • Experimental
    Glycopyrrolate Inhalation Solution 400μg

    Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

    Drug: Glycopyrrolate Inhalation Solution 400μg

  • Placebo comparator
    Placebo 0.5mL

    Placebo 0.5mL via e-flow nebulizer, once daily

    Drug: Placebo 0.5mL

Interventions

  • DrugGlycopyrrolate Inhalation Solution12.5μg

    Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

    Also known as: GIS

  • DrugGlycopyrrolate Inhalation Solution 50μg

    Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

    Also known as: GIS

  • DrugGlycopyrrolate Inhalation Solution 100μg

    Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

    Also known as: GIS

  • DrugGlycopyrrolate Inhalation Solution 200μg

    Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

    Also known as: GIS

  • DrugGlycopyrrolate Inhalation Solution 400μg

    Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

    Also known as: GIS

  • DrugPlacebo 0.5mL

    Placebo 0.5mL via eFlow, once daily

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24hr post dose

  2. 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.

    Time frame: 0-12h post dose

  3. 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.

    Time frame: 12-24h post dose

  4. 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.

    Time frame: 0 to 24h

  5. 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.

    Time frame: 0-4h post dose

Secondary outcomes

  1. Cmax; Maximum Observed Plasma Concentration

    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

    Time frame: 0 to 12 hour

  2. 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

    Time frame: 0 to 12 hours

  3. t1/2; Plasma Half-life

    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

    Time frame: 0 to 12 hour

  4. 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

    Time frame: 0 to 12 hour

  5. 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

    Time frame: 0 to 12 hour

  6. 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

    Time frame: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)

  7. 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.

    Time frame: 0-24 h

  8. 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.

    Time frame: Day -14, Day 69

  9. 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.

    Time frame: 0 to 24h

  10. 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

    Time frame: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)

07

Results

Posted Mar 12, 2018

Participant flow

Treatment Period 1
Participant flow — Treatment Period 1
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started777777
Completed777777
Not completed000000
Washout Period 1
Participant flow — Washout Period 1
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started777777
Completed757776
Not completed020001
Withdrew: Adverse event020000
Withdrew: Protocol violation000001
Treatment Period 2
Participant flow — Treatment Period 2
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started757776
Completed757776
Not completed000000
Washout Period 2
Participant flow — Washout Period 2
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started757776
Completed747676
Not completed010100
Withdrew: Adverse event010000
Withdrew: Personal reasons000100
Treatment Period 3
Participant flow — Treatment Period 3
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started747676
Completed747676
Not completed000000
Washout Period 3
Participant flow — Washout Period 3
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started747676
Completed747676
Not completed000000
Treatment Period 4
Participant flow — Treatment Period 4
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started747676
Completed747676
Not completed000000
Washout Period 4
Participant flow — Washout Period 4
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started747676
Completed646676
Not completed101000
Withdrew: Adverse event101000
Treatment Period 5
Participant flow — Treatment Period 5
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started646676
Completed646676
Not completed000000
Washout Period 5
Participant flow — Washout Period 5
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started646676
Completed646676
Not completed000000
Treatment Period 6
Participant flow — Treatment Period 6
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started646676
Completed646676
Not completed000000
Wshout Period 6
Participant flow — Wshout Period 6
MilestoneTreatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4Treatment Group 5Treatment Group 6
Started646676
Completed646676
Not completed000000

Outcome measures

PrimaryTrough 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.

Time frame:
24hr post dose
Reported as:
Mean · liters
Trough FEV1 (Change From Baseline)
litersGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
Trough FEV1 (Change From Baseline)-0.093 ± 0.11890.0114 ± 0.13080.0447 ± 0.15480.0542 ± 0.17790.0292 ± 0.1468-0.0612 ± 0.1233
Statistical analysis
  • Glycopyrrolate Inhalation Solution12.5μg vs Placebo 0.5mL · least squares mean · p = 0.1257 · Least squares mean: 0.033 · 95% CI -0.009 to 0.075
  • Glycopyrrolate Inhalation Solution 50μg vs Placebo 0.5mL · least squares mean · p = 0.0008 · Least squares mean: 0.072 · 95% CI 0.030 to 0.113
  • Glycopyrrolate Inhalation Solution 100μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.102 · 95% CI 0.061 to 0.144
  • Glycopyrrolate Inhalation Solution 200μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.108 · 95% CI 0.066 to 0.150
  • Glycopyrrolate Inhalation Solution 400μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.098 · 95% CI 0.056 to 0.140
PrimaryStandardized 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.

Time frame:
0-12h post dose
Reported as:
Mean · liters
Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline).
litersGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
actual standardized FEV1 AUC0_121.259 ± 0.4091.311 ± 0.4221.335 ± 0.3941.374 ± 0.3911.390 ± 0.4231.180 ± 0.427
change from baseline standardized FEV1 AUC0_120.055 ± 0.1130.126 ± 0.1120.136 ± 0.1340.184 ± 0.1340.170 ± 0.110-0.024 ± 0.095
Statistical analysis
  • Glycopyrrolate Inhalation Solution12.5μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.086 · 95% CI 0.050 to 0.123
  • Glycopyrrolate Inhalation Solution 50μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.151 · 95% CI 0.114 to 0.187
  • Glycopyrrolate Inhalation Solution 100μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.156 · 95% CI 0.120 to 0.193
  • Glycopyrrolate Inhalation Solution 200μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.202 · 95% CI 0.165 to 0.239
  • Glycopyrrolate Inhalation Solution 400μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.199 · 95% CI 0.162 to 0.235
PrimaryStandardized 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.

Time frame:
12-24h post dose
Reported as:
Mean · liters
Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline).
litersGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
acutal standardized FEV1 AUC0_121.165 ± 0.3771.203 ± 0.4041.227 ± 0.3691.253 ± 0.3461.259 ± 0.3961.123 ± 0.392
change from baseline standardized FEV1 AUC0_12-0.038 ± 0.1320.018 ± 0.1350.028 ± 0.1380.063 ± 0.1780.039 ± 0.135-0.082 ± 0.120
Statistical analysis
  • Glycopyrrolate Inhalation Solution12.5μg vs Placebo 0.5mL · least squares mean · p = 0.0028 · Least squares mean: 0.058 · 95% CI 0.021 to 0.095
  • Placebo 0.5mL · least squares mena · p = <0.0001 · Least squares mean: 0.100 · 95% CI 0.063 to 0.137
  • Glycopyrrolate Inhalation Solution 100μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.105 · 95% CI 0.068 to 0.142
  • Glycopyrrolate Inhalation Solution 200μg vs Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.135 · 95% CI 0.098 to 0.173
  • Placebo 0.5mL · least squares mean · p = <0.0001 · Least squares mean: 0.128 · 95% CI 0.091 to 0.166
PrimaryStandardized 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.

Time frame:
0 to 24h
Reported as:
Mean · liters
Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline)
litersGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
Actual standardized FEV1 AUC0_121.212 ± 0.3911.257 ± 0.4111.281 ± 0.3791.313 ± 0.3641.325 ± 0.4071.151 ± 0.408
change from baseline standardized FEV1 AUC0_120.009 ± 0.1140.072 ± 0.1150.082 ± 0.1280.123 ± 0.1460.105 ± 0.113-0.053 ± 0.102
PrimaryPeak 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.

Time frame:
0-4h post dose
Reported as:
Mean · liters
Peak FEV1 (Change From Baseline and Percent Change)
litersGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
Change from baseline0.165 ± 0.1130.229 ± 0.1130.260 ± 0.1510.292 ± 0.1200.272 ± 0.1250.061 ± 0.102
percent change from baseline15.30 ± 11.3721.05 ± 11.8724.14 ± 20.6926.73 ± 12.5625.44 ± 15.105.24 ± 8275
SecondaryCmax; Maximum Observed Plasma Concentration

Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

Time frame:
0 to 12 hour
Reported as:
Geometric mean · pg/mL
Cmax; Maximum Observed Plasma Concentration
pg/mLGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μg
Cmax; Maximum Observed Plasma Concentration59.25 ± 78.4974.48 ± 62.24144.58 ± 52.53316.05 ± 48.35504.93 ± 55.67
SecondaryTmax; 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

Time frame:
0 to 12 hours
Reported as:
Median · hours
Tmax; Time to Maximum Observed Plasma Concentration
hoursGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μg
Tmax; Time to Maximum Observed Plasma Concentration0.165 (0.150 to 0.180)0.320 (.0150 to 0.350)0.260 (0.150 to 0.330)0.275 (0.150 to 0.380)0.180 (0.150 to 0.320)
Secondaryt1/2; Plasma Half-life

Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

Time frame:
0 to 12 hour
Reported as:
Geometric mean · hours
t1/2; Plasma Half-life
hoursGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μg
t1/2; Plasma Half-life—0.8949 ± 2.37073.0137 ± 50.75573.1663 ± 45.48394.1238 ± 63.5353
SecondaryAUC0-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

Time frame:
0 to 12 hour
Reported as:
Geometric mean · pg.h/ml
AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.
pg.h/mlGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μg
AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.135.87 ± 209.2767.18 ± 143.22237.80 ± 98.45677.24 ± 66.341481.36 ± 82.17
SecondaryAUC0-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

Time frame:
0 to 12 hour
Reported as:
Geometric mean · pg.h/ml
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
pg.h/mlGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μg
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity—246.84 ± 37.49634.65 ± 34.28772.59 ± 26.301367.76 ± 76.70
SecondaryNumber 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

Time frame:
Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)
Reported as:
Number · participants
Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE
participantsGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
subjects who died000000
subjects with treatment emergent SAEs001000
Subjects whodiscontinued due to an AE222000
subjects with treatment emergent AEs161417151314
SecondaryNumber 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.

Time frame:
0-24 h
Reported as:
Count of participants · Participants
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
ParticipantsGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study000000
SecondaryNumber 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.

Time frame:
Day -14, Day 69
Reported as:
Number · number of events
Number of Clinically Significant Abnormal Laboratory Results Reported During the Study
number of eventsGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
Number of Clinically Significant Abnormal Laboratory Results Reported During the Study000000
SecondaryNumber 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.

Time frame:
0 to 24h
Reported as:
Count of participants · Participants
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
ParticipantsGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study000000
SecondaryPercentage 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

Time frame:
Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)
Reported as:
Number · percentage of participants
Percentage of Subjects With Treatment Emergent AEs
percentage of participantsGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
Percentage of Subjects With Treatment Emergent AEs41.036.845.940.535.137.8

Adverse events

Collected over 0-69 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Glycopyrrolate Inhalation Solution12.5μg—0/39 (0%)13/39 (33.3%)
Glycopyrrolate Inhalation Solution 50μg—0/38 (0%)9/38 (23.7%)
Glycopyrrolate Inhalation Solution 100μg—1/37 (2.7%)10/37 (27%)
Glycopyrrolate Inhalation Solution 200μg—0/37 (0%)10/37 (27%)
Glycopyrrolate Inhalation Solution 400μg—0/37 (0%)10/37 (27%)
Placebo 0.5mL—0/37 (0%)10/37 (27%)
Most frequent serious events
Most frequent serious events
EventGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
groin painGeneral disorders0/390/381/370/370/370/37
Most frequent other events
Most frequent other events
EventGlycopyrrolate Inhalation Solution12.5μgGlycopyrrolate Inhalation Solution 50μgGlycopyrrolate Inhalation Solution 100μgGlycopyrrolate Inhalation Solution 200μgGlycopyrrolate Inhalation Solution 400μgPlacebo 0.5mL
headacheNervous system disorders6/395/385/377/376/374/37
coughRespiratory, thoracic and mediastinal disorders3/392/385/373/373/375/37
dyspnoeaRespiratory, thoracic and mediastinal disorders3/392/381/371/371/372/37
skin injuryInjury, poisoning and procedural complications0/390/380/370/370/372/37
chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders2/391/380/370/370/370/37

Baseline characteristics

Intent to treat population same as safety population -not full analysis set

Age, Categorical
Age, Categorical(Participants)Total Participants
<=18 years0
Between 18 and 65 years29
>=65 years13
Age, Continuous
Age, Continuous(years)Total Participants
Mean62.0 ± 6.99
Sex: Female, Male
Sex: Female, Male(Participants)Total Participants
Female15
Male27
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Total Participants
Hispanic or Latino0
Not Hispanic or Latino42
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Total Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White41
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Total Participants
United Kingdom42
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02948582
Lead sponsor
Sunovion Respiratory Development Inc.
Responsible party
Sponsor
First posted
Oct 28, 2016
Start date
Jul 2010
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
Mar 12, 2018
Last update
Mar 12, 2018

Study contacts

Ahmet Tutuncu, MD, PhD
study chair · Elevation Pharmaceuticals, Inc., (now known as Sunovion Respriatory Developement Inc.)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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