Trial Outcomes & Findings for A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD (NCT NCT03836677)
NCT ID: NCT03836677
Last Updated: 2021-02-11
Results Overview
Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Baseline, Day 29
Results posted on
2021-02-11
Participant Flow
This study randomized 23 subjects at 4 study centers (1 center in Belgium and 3 centers in the Netherlands) from Feb 2019 to Nov 2019.
Subjects were randomized into 1 of 2 treatment sequences. Sequence 1 received BGF MDI in Period 1 followed by GFF MDI in Period 2. Sequence 2 received GFF MDI in Period 1 followed by BGF MDI in Period 2.
Participant milestones
| Measure |
BGF MDI/GFF MDI
Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation followed by Washout and then Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI/BGF MDI
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation followed by Washout and then Budesonide/Glycopyrronium/Formoterol Metered Dose Inhalation
|
|---|---|---|
|
Period 1
STARTED
|
13
|
10
|
|
Period 1
COMPLETED
|
13
|
9
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
Washout
STARTED
|
13
|
9
|
|
Washout
COMPLETED
|
13
|
9
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
13
|
9
|
|
Period 2
COMPLETED
|
12
|
9
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
BGF MDI/GFF MDI
Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation followed by Washout and then Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI/BGF MDI
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation followed by Washout and then Budesonide/Glycopyrronium/Formoterol Metered Dose Inhalation
|
|---|---|---|
|
Period 1
Adverse Event
|
0
|
1
|
|
Period 2
Severe non-compliance to protocol
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Baseline characteristics by cohort
| Measure |
Overall Study
n=23 Participants
ITT Population
|
|---|---|
|
Age, Continuous
|
64.9 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 29Population: ITT Population
Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
Outcome measures
| Measure |
BGF MDI
n=20 Participants
Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI
n=21 Participants
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Specific Image-based Airway Volume (siVaw)
|
1.72 Ratio to baseline
Interval 1.38 to 2.13
|
1.53 Ratio to baseline
Interval 1.28 to 1.83
|
PRIMARY outcome
Timeframe: Baseline, Day 29Population: ITT Population
Specific image-based airway resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
Outcome measures
| Measure |
BGF MDI
n=20 Participants
Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI
n=21 Participants
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Specific Image-based Airway Resistance (siRaw)
|
0.50 Ratio to baseline
Interval 0.39 to 0.63
|
0.52 Ratio to baseline
Interval 0.4 to 0.67
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: ITT Population
Image-based Airway Volume (iVaw) measured in mL. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
Outcome measures
| Measure |
BGF MDI
n=20 Participants
Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI
n=21 Participants
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Image-based Airway Volume (iVaw)
|
1.70 Ratio to baseline
Interval 1.37 to 2.11
|
1.51 Ratio to baseline
Interval 1.26 to 1.8
|
SECONDARY outcome
Timeframe: Baseline, 29 DaysPopulation: ITT Population
Image-based airway resistance (iRaw) measured in kPa∙s/L. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
Outcome measures
| Measure |
BGF MDI
n=20 Participants
Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI
n=21 Participants
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Image-based Airway Resistance (iRaw)
|
0.50 Ratio to baseline
Interval 0.4 to 0.63
|
0.52 Ratio to baseline
Interval 0.4 to 0.68
|
SECONDARY outcome
Timeframe: Baseline 29 DaysPopulation: ITT Population
Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1).
Outcome measures
| Measure |
BGF MDI
n=21 Participants
Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI
n=21 Participants
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Forced Expiratory Volume in One Second (Post-dose FEV1).
|
0.346 L
Interval 0.182 to 0.509
|
0.273 L
Interval 0.14 to 0.405
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: ITT Population
Change from baseline in Functional residual capacity (FRC).
Outcome measures
| Measure |
BGF MDI
n=22 Participants
Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI
n=21 Participants
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Functional Residual Capacity (FRC)
|
-0.28 L
Interval -0.77 to 0.21
|
-0.50 L
Interval -0.81 to -0.18
|
Adverse Events
BGF MDI
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
GFF MDI
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BGF MDI
n=22 participants at risk
Budoesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI
n=23 participants at risk
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from visit 2 throughout the treatment period and including the follow-up period telephone call.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events were collected visit 2 throughout the treatment period and including the follow-up period telephone call.
|
0.00%
0/23 • Adverse events were collected from visit 2 throughout the treatment period and including the follow-up period telephone call.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events were collected visit 2 throughout the treatment period and including the follow-up period telephone call.
|
Other adverse events
| Measure |
BGF MDI
n=22 participants at risk
Budoesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
GFF MDI
n=23 participants at risk
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • Adverse events were collected from visit 2 throughout the treatment period and including the follow-up period telephone call.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events were collected visit 2 throughout the treatment period and including the follow-up period telephone call.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from visit 2 throughout the treatment period and including the follow-up period telephone call.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events were collected visit 2 throughout the treatment period and including the follow-up period telephone call.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60