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Trial record 13 of 185 for:    GLYCOPYRROLATE

Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). (GOLDEN7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02512302
Recruitment Status : Completed
First Posted : July 30, 2015
Results First Posted : September 14, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition COPD
Interventions Drug: SUN-101 via eFlow nebulizer
Drug: SUN-101 via eFlow nebulizer with activated charcoal
Drug: Seebri® Breezhaler®
Drug: Seebri® Breezhaler® with activated charcoal
Drug: Glycopyrrolate Injection
Enrollment 30
Recruitment Details  
Pre-assignment Details Eligible subjects will be randomized to one of 10 treatment sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned.
Arm/Group Title Treatment Group One Treatment Group Two Treatment Group Three Treatment Group Four Treatment Group Five Treatment Group Six Treatment Group Seven Treatment Group Eight Treatment Group Nine Treatment Group Ten
Hide Arm/Group Description Participants received Seebri Breezhaler with activated charcoal 63 mcg; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via e flow nebulizer; Seebri Breezhaler 63 mcg for each of the five treatment periods Participants received SUN-101 50 mcg via eFlow nebulizer, SUN-101 50 mcg via eFlow nebulier with activated charcoal; Seebri Breezhaler 63 mcg, Seebri Breezhaler 63 mcg with activated charcoal; Glycopyrrolate injection via IV infusion for each of the five treatment periods Participants recveived SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg; SUN-101 50mcg via eFlow nebulizer with activated charcoal; Glycopyrrolate injection via IV infusion; Seebri Breezerhaler 63mcg with activated charcoal for each of the five treatment periods Participants received Glycopyrrolate injection via IV infusion; Seebri Breezhaler 63mcg with activated charcoal; Seebri Breezhaler 63mcg; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; SUN-101 50 mcg via eFlow nebulizer for each of the five treatment periods Participants received Seebri Breezhaler 63mcg ; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; for each of the five treatment periods Participants received Seebri Breezhaler 63mcg with activated charcoal ; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg SUN-101 50 mcg via eFlow nebulizer for each of the five treatment periods Participants received Seebri Breezhaler 63mcg ; SUN-101 50 mcg via eFlow nebulizer; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg with activated charcoal for each of the five treatment periods Participants received SUN-101 50 mcg via eFlow nebulizer with activated charcoal; SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg with activated charcoal; Seebri Breezhaler 63 mcg; Glycopyrrolate injection via IV infusion for each of the five treatment periods Participants received Glycopyrrolate injection via IV infusion; Seebri Breezhaler 63 mcg; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer SUN-101 50 mcg via eFlow nebulizer with activated charcoalfor each of the five treatment periods Participants received SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer; Glycopyrrolate injection via IV infusion;Seebri Breezhaler 63mcg for each of the five treatment periods
Period Title: Period 1
Started 3 3 4 3 3 3 2 3 3 3
Completed 3 2 4 3 3 3 2 3 3 3
Not Completed 0 1 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0             0             0             0             0             0
Period Title: Period 2
Started 3 2 4 3 3 3 2 3 3 3
Completed 3 2 4 3 3 3 2 3 3 2
Not Completed 0 0 0 0 0 0 0 0 0 1
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             1
Period Title: Period 3
Started 3 2 4 3 3 3 2 3 3 2
Completed 3 2 3 3 3 3 2 3 3 2
Not Completed 0 0 1 0 0 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             0             0             1             0             0             0             0             0             0             0
Period Title: Period 4
Started 3 2 3 3 3 3 2 3 3 2
Completed 3 2 3 3 3 3 1 3 3 2
Not Completed 0 0 0 0 0 0 1 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0             0             0
Period Title: Period 5
Started 3 2 3 3 3 3 1 3 3 2
Completed 3 2 3 3 3 3 1 3 3 2
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Total
Hide Arm/Group Description Total number of participants from all treatment groups
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
  73.3%
>=65 years
8
  26.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
6
  20.0%
Male
24
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
30
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
28
  93.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 30 participants
30
1.Primary Outcome
Title Cmax
Hide Description maximum observed concentration-Cmax is calculated from plasma concentrations analyzed from blood samples collected between 0 and 48 hr.
Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication and have any evaluable PK data
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 29 29 28 26 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Pg/mL
53.75
(51.746%)
49.27
(60.996%)
166.79
(76.348%)
148.03
(39.841%)
3787.47
(115.166%)
2.Primary Outcome
Title Area Under the Curve From Time Zero to 24 Hours (AUC0_24)
Hide Description Area under the drug concentration-time curve from time zero to 24 hours postdose pk parameteres are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr
Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication and have any evaluable PK data
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 29 29 28 26 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
172.23
(100.974%)
159.12
(92.720%)
472.35
(90.233%)
428.52
(46.985%)
1961.79
(142.488%)
3.Primary Outcome
Title Area Under the Curve From Time Zero to Infinity (AUC0_infinity)
Hide Description

calculated by summing AUC0-last and the AUC extrapolated from tlast to infinity: AUC0–∞ = AUC0-last+ Clast / | λz | Clast / | λz | is the extrapolated area under the curve from tlast to infinity. If this quantity is greater than 20% of AUC0-∞, then AUC0-∞ was considered to be missing.

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 8 6 15 10 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
234.23
(77.206%)
167.84
(41.208%)
607.53
(79.340%)
570.90
(63.913%)
2550.85
(117.068%)
4.Secondary Outcome
Title Clearance (CL) for IV Infusion of 50 mcg of Glycopyrrolate
Hide Description

calculated as Dose/AUC0-inf after the IV dose administration. If AUC0-inf is missing, then CL was considered as missing.

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters/hr
19.60
(117.068%)
5.Secondary Outcome
Title Volume of Distribution During the Elimination Phase (Vz) for IV Infusion of 50 mcg of Glycopyrrolate
Hide Description calculated as Dose/(AUC0–inf*λz). Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
113.06
(131.141%)
6.Secondary Outcome
Title Time of Occurrence of Cmax (Tmax) for IV Infusion of 50 mcg of Glycopyrrolate
Hide Description The time 0 is based on start of the infusion. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 27
Median (Full Range)
Unit of Measure: hr
0.100
(0.08 to 0.40)
7.Secondary Outcome
Title Terminal Half Life (t1/2) for IV Infusion of 50 mcg of Glycopyrrolate
Hide Description

calculated as ln(2) / λz . At least 3 data points at the terminal elimination phase were required to determine t½.

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
3.998
(111.8589%)
8.Secondary Outcome
Title Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri Breezhaler and Sun-101 AUC0-48, CL/F, Vz/F, Tmax, t½, and Dose Normalized Cmax, AUC0-24, AUC0-48, AUC0-∞ - AUC0-∞ -
Hide Description Area under the drug concentration-time curve from time zero to 48 hours postdose Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 29 29 28 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
182.59
(112.339%)
179.78
(108.906%)
524.18
(99.365%)
485.99
(56.588%)
9.Secondary Outcome
Title Apparent Clearance Calculated as Dose/AUC0-INF After Extravascular Dose Administration of Seebri Breezhaler and SUN-101
Hide Description

calculated as Dose/AUC0-∞ after extravascular dose administration, where F = Bioavailability. If AUC0-∞ is missing, then CL/F is considered as missing.

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

Time Frame up to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 8 6 15 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
213.47
(77.206%)
297.91
(41.208%)
103.70
(79.340%)
110.35
(63.913%)
10.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) After Extravascular Dose Administration of Seebri Breezhaler and SUN-101
Hide Description

calculated as Dose/(AUC0-∞* λz), where F = Bioavailability. If AUC0-∞ is missing, then Vz/F is considered as missing.

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr

Time Frame up to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 8 6 15 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters
1263.63
(31.716%)
1668.59
(17.994%)
1305.30
(23.585%)
1708.81
(22.543%)
11.Secondary Outcome
Title Time of Occurrence of Cmax (Tmax) for Seebri Breezhaler and SUN-101
Hide Description The time 0 is based on start of the inhalation. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Time Frame up to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 29 29 28 26
Median (Full Range)
Unit of Measure: hr
0.317
(0.08 to 12.05)
0.250
(0.07 to 12.3)
0.250
(0.03 to 1.57)
0.250
(0.05 to 0.40)
12.Secondary Outcome
Title Terminal Half Life (t1/2) for for Seebri Breezhaler and SUN-101
Hide Description

calculated as ln(2) / λz . At least 3 data points at the terminal elimination phase were required to determine t½.

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

Time Frame up to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 13 10 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
6.554
(135.6286%)
5.191
(61.4971%)
10.378
(80.1891%)
14.866
(69.3836%)
13.Secondary Outcome
Title Dose Normalized Cmax for Seebri and SUN-101.
Hide Description

Maximum observed concentration multiplied by the dose normalization factor. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9.

Time Frame up to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 29 29 28 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Pg/mL
85.46
(51.746%)
78.33
(60.996%)
150.11
(76.348%)
133.22
(39.841%)
14.Secondary Outcome
Title Dose Normalized Area Under the Curve Zero to 24 Hours (AUC0_24) for Seebri and SUN-101
Hide Description

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

Area under the drug concentration-time curve from time zero to 24 hours postdose multiplied by the dose normalization factor. The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9.

Time Frame up to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
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50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 29 29 28 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
273.85
(100.974%)
253.00
(92.720%)
425.12
(90.233%)
385.67
(46.985%)
15.Secondary Outcome
Title Dose Normalized Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri and SUN-101
Hide Description

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

Area under the drug concentration-time curve from time zero to 48 hours postdose multiplied by the dose normalization factor. The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9.

Time Frame up to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
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50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 29 29 28 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
290.32
(112.339%)
285.85
(108.906%)
471.76
(99.365%)
437.39
(56.588%)
16.Secondary Outcome
Title Dose Normalized Area Under the Curve Zero From Zero to Infinity (AUC0_inf) for Seebri and SUN-101
Hide Description

Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.

Area under the drug concentration-time curve from zero to infinity, calculated by summing AUC0-last and the AUC extrapolated from tlast to infinity multiplied by the dose normalization factor: dose normalization factor* (AUC0–∞ = AUC0-last+ Clast / | λz | ) Clast / | λz | is the extrapolated area under the curve from tlast to infinity. If this quantity is greater than 20% of AUC0-∞, then AUC0-∞ was considered to be missing.

The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50mcg , the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9.

Time Frame up to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Overall Number of Participants Analyzed 8 6 15 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
372.42
(77.206%)
266.86
(41.208%)
546.78
(79.340%)
513.81
(63.931%)
17.Secondary Outcome
Title The Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Hide Description An adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 29 29 28 27 27
Measure Type: Number
Unit of Measure: participants
Adverse Events 6 9 7 11 7
Serious Adverse Events 0 0 0 0 0
Adverse events leading to discontinuation 1 1 0 1 0
18.Secondary Outcome
Title The Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Hide Description An adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Time Frame Up to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Hide Arm/Group Description:

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

Overall Number of Participants Analyzed 29 29 28 27 27
Measure Type: Number
Unit of Measure: percentage of participants
Adverse Events 20.7 31.0 25.0 40.7 25.9
Serious Adverse Events 0 0 0 0 0
Adverse events leading to discontinuation 3.4 3.4 0 3.7 0
Time Frame up to week 5
Adverse Event Reporting Description A serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
 
Arm/Group Title SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Hide Arm/Group Description

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

50 mcg glycopyrrolate via IV infusion

Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV

All-Cause Mortality
SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/29 (0.00%)      0/28 (0.00%)      0/27 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SUN-101 Via eFlow Nebulizer SUN-101 Via eFlow Nebulizer With Activated Charcoal Seebri® Breezhaler® Seebri® Breezhaler® With Activated Charcoal : Glycopyrrolate Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      3/29 (10.34%)      3/28 (10.71%)      5/27 (18.52%)      4/27 (14.81%)    
Musculoskeletal and connective tissue disorders           
back pain  1  0/29 (0.00%)  0 0/29 (0.00%)  0 2/28 (7.14%)  2 1/27 (3.70%)  1 0/27 (0.00%)  0
Nervous system disorders           
headache  1  1/29 (3.45%)  1 3/29 (10.34%)  3 1/28 (3.57%)  1 4/27 (14.81%)  4 4/27 (14.81%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Respiratory Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Layout table for additonal information
Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT02512302     History of Changes
Other Study ID Numbers: SUN101-105
First Submitted: July 24, 2015
First Posted: July 30, 2015
Results First Submitted: January 2, 2018
Results First Posted: September 14, 2018
Last Update Posted: October 25, 2018