Trial Outcomes & Findings for A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma (NCT NCT04203797)
NCT ID: NCT04203797
Last Updated: 2024-04-18
Results Overview
CWRET (Constant Work Rate Exercise Test) will be performed on an electromagnetically-braked cycle ergometer in an exercise physiology laboratory overseen by a trained pulmonologist or medical doctor designee.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Up to week 12
Results posted on
2024-04-18
Participant Flow
127 participants screened, 87 screen-fail, 40 participants randomized
Participant milestones
| Measure |
Placebo
Matching dupilumab placebo
|
Dupilumab
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Matching dupilumab placebo
|
Dupilumab
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Did not complete End of Study follow-up
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Matching dupilumab placebo
|
Dupilumab
n=20 Participants
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
45.3 Years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
45.9 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to week 12Population: The full analysis set (FAS) includes all randomized participants. The FAS is based on the treatment allocated (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
CWRET (Constant Work Rate Exercise Test) will be performed on an electromagnetically-braked cycle ergometer in an exercise physiology laboratory overseen by a trained pulmonologist or medical doctor designee.
Outcome measures
| Measure |
Placebo
n=17 Participants
Matching dupilumab placebo
|
Dupilumab
n=20 Participants
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
|---|---|---|
|
Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)
|
0.923 Minutes
Interval -0.614 to 2.46
|
1.742 Minutes
Interval -0.054 to 3.538
|
SECONDARY outcome
Timeframe: Up to week 12Population: The full analysis set (FAS) includes all randomized participants. The FAS is based on the treatment allocated (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Based on accelerometry data
Outcome measures
| Measure |
Placebo
n=15 Participants
Matching dupilumab placebo
|
Dupilumab
n=16 Participants
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
|---|---|---|
|
Change From Baseline to Week 12 in Average Number of Steps Walked Per Day
|
-1066.11 Steps
Interval -2921.32 to 789.1
|
925.92 Steps
Interval -691.46 to 2543.3
|
SECONDARY outcome
Timeframe: Up to week 12Population: The full analysis set (FAS) includes all randomized participants. The FAS is based on the treatment allocated (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Metabolic equivalents of tasks \[METs\]. Based on accelerometry data
Outcome measures
| Measure |
Placebo
n=15 Participants
Matching dupilumab placebo
|
Dupilumab
n=16 Participants
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
|---|---|---|
|
Change From Baseline to Week 12 in Total Energy Expenditure
|
23.40 METs (metabolic equivalent of task)
Interval -87.37 to 134.17
|
59.36 METs (metabolic equivalent of task)
Interval -15.83 to 134.55
|
SECONDARY outcome
Timeframe: Up to week 12Population: The full analysis set (FAS) includes all randomized participants. The FAS is based on the treatment allocated (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Defined as ≥3 METs. Based on accelerometry data
Outcome measures
| Measure |
Placebo
n=15 Participants
Matching dupilumab placebo
|
Dupilumab
n=16 Participants
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
|---|---|---|
|
Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity
|
-11.01 Minutes
Interval -30.52 to 8.5
|
9.38 Minutes
Interval -13.41 to 32.18
|
SECONDARY outcome
Timeframe: Up to week 12Population: The full analysis set (FAS) includes all randomized participants. The FAS is based on the treatment allocated (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Based on spirometry data
Outcome measures
| Measure |
Placebo
n=20 Participants
Matching dupilumab placebo
|
Dupilumab
n=20 Participants
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
|---|---|---|
|
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
Change from Baseline to Week 12 (Pre-exercise)
|
0.2123 Liters
Interval 0.0072 to 0.4174
|
0.4205 Liters
Interval 0.1409 to 0.7
|
|
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
Change from Baseline to Week 12 (2-min Post-Exercise)
|
0.2550 Liters
Interval -0.239 to 0.749
|
0.2902 Liters
Interval 0.0886 to 0.4919
|
|
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
Change from Baseline to Week 12 (5-min Post-Exercise)
|
0.2416 Liters
Interval 0.0238 to 0.4593
|
0.4156 Liters
Interval 0.1505 to 0.6808
|
|
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
Change from Baseline to Week 12 (10-min Post-Exercise)
|
0.2211 Liters
Interval 0.018 to 0.4243
|
0.4613 Liters
Interval 0.2167 to 0.706
|
|
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
Change from Baseline to Week 12 (20-min Post-Exercise)
|
0.2496 Liters
Interval 0.0608 to 0.4384
|
0.4738 Liters
Interval 0.223 to 0.7245
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Dupilumab 300 mg Q2W
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Matching dupilumab placebo
|
Dupilumab 300 mg Q2W
n=20 participants at risk
A loading dose at the start of the treatment followed by once every two weeks (Q2W).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
2/20 • Number of events 2 • Up to 22 weeks
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/20 • Up to 22 weeks
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • Up to 22 weeks
|
5.0%
1/20 • Number of events 2 • Up to 22 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • Up to 22 weeks
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Infections and infestations
COVID-19
|
15.0%
3/20 • Number of events 3 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Infections and infestations
Respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/20 • Up to 22 weeks
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
|
Eye disorders
Eye discharge
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 3 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • Up to 22 weeks
|
0.00%
0/20 • Up to 22 weeks
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER