Trial Outcomes & Findings for Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (NCT NCT02587351)
NCT ID: NCT02587351
Last Updated: 2021-01-25
Results Overview
Acute exacerbations are defined as a "complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness requiring treatment with antibiotics and/or systemic steroids for at least three days".
TERMINATED
PHASE3
532 participants
1 year
2021-01-25
Participant Flow
Participant milestones
| Measure |
Metoprolol Succinate
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
268
|
264
|
|
Overall Study
COMPLETED
|
268
|
264
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
146 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
178 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
83 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
268 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
532 Participants
n=5 Participants
|
|
FEV1 after bronchodilation - % of predicted value
|
41.3 % of predicted value
STANDARD_DEVIATION 16.3 • n=5 Participants
|
40.8 % of predicted value
STANDARD_DEVIATION 16.2 • n=7 Participants
|
41.1 % of predicted value
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
FEV1:FVC ratio - %
|
44.2 ratio %
STANDARD_DEVIATION 11.7 • n=5 Participants
|
45.2 ratio %
STANDARD_DEVIATION 21.6 • n=7 Participants
|
44.7 ratio %
STANDARD_DEVIATION 17.3 • n=5 Participants
|
|
Smoking history No. of pack-yr
|
50.7 pack-years
STANDARD_DEVIATION 28.7 • n=5 Participants
|
49.5 pack-years
STANDARD_DEVIATION 29.6 • n=7 Participants
|
50.1 pack-years
STANDARD_DEVIATION 29.1 • n=5 Participants
|
|
Systolic Blood pressure - mm Hg
|
128.4 mm Hg
STANDARD_DEVIATION 16.5 • n=5 Participants
|
130.6 mm Hg
STANDARD_DEVIATION 15.9 • n=7 Participants
|
129.5 mm Hg
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Diastolic Blood pressure - mm Hg
|
77.2 mm Hg
STANDARD_DEVIATION 9.2 • n=5 Participants
|
76.8 mm Hg
STANDARD_DEVIATION 9.1 • n=7 Participants
|
77.0 mm Hg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearAcute exacerbations are defined as a "complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness requiring treatment with antibiotics and/or systemic steroids for at least three days".
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Time to First Occurrence of an Acute COPS Exacerbation
|
202 days
Interval 162.0 to 282.0
|
222 days
Interval 189.0 to 295.0
|
SECONDARY outcome
Timeframe: 1 yearNumber of acute exacerbations of COPD - rate per person-year
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Number of Acute Exacerbations of COPD
|
1.40 no. of events/person-yr
Interval 1.21 to 1.61
|
1.33 no. of events/person-yr
Interval 1.15 to 1.54
|
SECONDARY outcome
Timeframe: 1 yearNumber of Emergency Department visits resulting from acute exacerbations of COPD - rate
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Number of Emergency Department Visits Resulting From Acute Exacerbations of COPD
|
0.17 events per person-year
Interval 0.11 to 0.25
|
0.18 events per person-year
Interval 0.12 to 0.26
|
SECONDARY outcome
Timeframe: 1 yearNumber of hospital admissions resulting from acute exacerbations of COPD - rate
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Number of Hospital Admissions Resulting From Acute Exacerbations of COPD
|
0.66 events per person-year
Interval 0.47 to 0.86
|
0.42 events per person-year
Interval 0.3 to 0.55
|
SECONDARY outcome
Timeframe: 14 monthsNumber of hospital days resulting from acute exacerbations of COPD reported as negative binomial estimates of mean hospital days per patient year.
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Hospital Days Resulting From Acute Exacerbations of COPD
|
3.09 hospital days
Interval 2.05 to 4.64
|
0.96 hospital days
Interval 0.62 to 1.48
|
SECONDARY outcome
Timeframe: 12 monthsMajor adverse cardiovascular events (MACE), percutaneous coronary intervention or coronary artery bypass grafting. MACE defined by cardiovascular death, hospitalization for myocardial infarction, heart failure, or stroke
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Major Adverse Cardiovascular Events
Myocardial Infarction
|
2 Participants
|
1 Participants
|
|
Major Adverse Cardiovascular Events
Heart Failure
|
2 Participants
|
3 Participants
|
|
Major Adverse Cardiovascular Events
Stroke
|
1 Participants
|
1 Participants
|
|
Major Adverse Cardiovascular Events
Sudden Cardiac Death
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearAll-cause mortality count
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
All-cause Mortality
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 yearNew or worsened (Neural: depression, headache, syncope, seizures, somnolence, memory loss, loss of sexual desire or erectile dysfunction, and fatigue; Hypersensitivity: rash, pruritus, tongue or facial swelling; Gastrointestinal: diarrhea, vomiting, nausea or constipation; Cardiovascular: bradycardia and hypotension as discussed below; Respiratory: bronchospasm and changes in lung function as discussed below).
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Incidence of Presumed Metoprolol-related Side-effects
Depression
|
28 Participants
|
39 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Headache
|
71 Participants
|
78 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Fainting
|
4 Participants
|
8 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Daytime Sleepiness
|
58 Participants
|
70 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Memory Loss
|
20 Participants
|
21 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Loss of sexual desire or erectile dysfunction
|
10 Participants
|
6 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Lack of energy
|
91 Participants
|
77 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Rash
|
17 Participants
|
21 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Itching
|
11 Participants
|
18 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Tongue or facial swelling
|
7 Participants
|
5 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Vomiting
|
11 Participants
|
18 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Nausea
|
45 Participants
|
42 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Constipation
|
30 Participants
|
32 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Wheezing
|
88 Participants
|
79 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Shortness of breath
|
115 Participants
|
112 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Chest tightness
|
81 Participants
|
80 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Heart skipping or irregular beats
|
16 Participants
|
15 Participants
|
|
Incidence of Presumed Metoprolol-related Side-effects
Dizziness/light headedness
|
74 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with data at baseline and visit day 336
Modified Medical Research Council Dyspnea Scale (MMRC) change from baseline to visit day 336. The MMRC scale is a five-point scale originally published in 1959 that considers certain activities, such as walking or climbing stairs, which provoke breathlessness. Scale from 0 to 4 with lower scores indicating less breathlessness.
Outcome measures
| Measure |
Metoprolol Succinate
n=207 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=201 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Modified Medical Research Council Dyspnea Scale (MMRC)
|
2.0 score on a scale
Interval 1.0 to 3.0
|
2.0 score on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with data at baseline and visit day 336
Change in FEV1 % Predicted from baseline to visit day 336 as assessed by spirometry
Outcome measures
| Measure |
Metoprolol Succinate
n=193 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=197 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
|
-2.24 percentage of predicted
Interval -3.28 to -1.2
|
-1.46 percentage of predicted
Interval -2.5 to -0.42
|
SECONDARY outcome
Timeframe: Baseline, 1 yearPopulation: Participants with data at baseline and visit day 336
6MWD change from baseline to visit day 336. The 6MWD has been used as a simple tool to assess overall exercise tolerance in patients with chronic cardiopulmonary disease including COPD.
Outcome measures
| Measure |
Metoprolol Succinate
n=174 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=166 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Exercise Capacity as Assessed by the 6 Minute Walk Distance (6MWD)
|
-17.64 meters
Interval -28.75 to -6.53
|
-11.87 meters
Interval -23.21 to -0.54
|
SECONDARY outcome
Timeframe: Baseline, 1 yearFibrinogen: assessed at screening/randomization and at conclusion of the study to determine if beta-blockade impacts levels of systemic inflammation that portend overall cardiac risk.
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Markers of Systemic Inflammation
Fibrinogen baseline
|
384.8 mg/dL
Standard Deviation 94.6
|
378.2 mg/dL
Standard Deviation 91.9
|
|
Markers of Systemic Inflammation
Fibrinogen Visit 336
|
392.5 mg/dL
Standard Deviation 90.5
|
386.0 mg/dL
Standard Deviation 110.0
|
SECONDARY outcome
Timeframe: Baseline, 1 yearPopulation: Participants with data at baseline and visit day 336
SGRQ change from baseline to visit day 336. The SGRQ total score change from baseline. SGRQ is a respiratory specific health status questionnaire with scores ranging from 0 to 100. The lower score indicates a better health status.
Outcome measures
| Measure |
Metoprolol Succinate
n=203 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=200 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ)
|
0.52 score on a scale
Interval -1.01 to 2.04
|
-0.25 score on a scale
Interval -1.79 to 1.28
|
SECONDARY outcome
Timeframe: Baseline, 1 yearPopulation: Participants with data at baseline and visit day 336
COPD Assessment Test (CAT) change from baseline. The CAT is a simple, eight item, health status instrument for patients with COPD that provides a score of 0-40. Lower scores denote better health status.
Outcome measures
| Measure |
Metoprolol Succinate
n=206 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=200 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
COPD Assessment Test (CAT)
|
0.88 score on a scale
Interval 0.07 to 1.69
|
-0.59 score on a scale
Interval -1.41 to 0.23
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with data at baseline and visit day 336
San Diego Shortness of Breath Questionnaire (SOBQ) change from baseline. A 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. Each item has a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness").
Outcome measures
| Measure |
Metoprolol Succinate
n=204 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=199 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
San Diego Shortness of Breath Questionnaire (SOBQ)
|
0.52 score on a scale
Interval -1.01 to 2.04
|
-0.25 score on a scale
Interval -1.79 to 1.28
|
SECONDARY outcome
Timeframe: 12 monthsMACE defined by cardiovascular death, hospitalization for myocardial infarction, heart failure, or stroke
Outcome measures
| Measure |
Metoprolol Succinate
n=268 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Acute Exacerbations of COPD and MACE
Myocardial Infarction
|
2 Participants
|
1 Participants
|
|
Acute Exacerbations of COPD and MACE
Heart Failure
|
2 Participants
|
3 Participants
|
|
Acute Exacerbations of COPD and MACE
Stroke
|
1 Participants
|
1 Participants
|
|
Acute Exacerbations of COPD and MACE
Sudden cardiac death
|
0 Participants
|
1 Participants
|
|
Acute Exacerbations of COPD and MACE
COPD Exacerbation (Serious)
|
55 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with SF-36 data available
Short Form Health Survey (SF-36) is a generic tool to assess overall health status and allows comparison between different diseases. 8 multi-item scales with higher score indicating better health state. The Physical Functioning scale is 10 items assessing the extent to which health limits physical activities such as self-care, walking, climbing stairs, bending lifting, and moderate and vigorous activities transformed to a score with a range of 0-100.
Outcome measures
| Measure |
Metoprolol Succinate
n=265 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=262 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Short Form Health Survey (SF-36) Physical Function Scale
Baseline
|
30.0 Units on a scale
Interval 15.0 to 50.0
|
30.0 Units on a scale
Interval 15.0 to 45.0
|
|
Short Form Health Survey (SF-36) Physical Function Scale
Day 112 visit
|
30.0 Units on a scale
Interval 15.0 to 55.0
|
30.0 Units on a scale
Interval 15.0 to 50.0
|
|
Short Form Health Survey (SF-36) Physical Function Scale
Day 336 Visit
|
30.0 Units on a scale
Interval 15.0 to 50.0
|
35.0 Units on a scale
Interval 15.0 to 50.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with SF-36 data available
Short Form Health Survey (SF-36) is a generic tool to assess overall health status and allows comparison between different diseases. Includes 8 multi-item scales with higher score indicating better health state. The Role Functioning - Physical Scale contains 4 items assessing the extent to which physical health interferes with work or other daily activities, including accomplished less than wanted, limitations in the kind of activities. Items are transformed to a score with a range of 0-100.
Outcome measures
| Measure |
Metoprolol Succinate
n=265 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=262 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Short Form Health Survey (SF-36) Role Functioning - Physical Scale
Baseline
|
25.0 Units on a scale
Interval 0.0 to 50.0
|
25.0 Units on a scale
Interval 0.0 to 56.2
|
|
Short Form Health Survey (SF-36) Role Functioning - Physical Scale
Day 112 visit
|
25.0 Units on a scale
Interval 0.0 to 75.0
|
25.0 Units on a scale
Interval 0.0 to 75.0
|
|
Short Form Health Survey (SF-36) Role Functioning - Physical Scale
Day 336 Visit
|
12.5 Units on a scale
Interval 0.0 to 75.0
|
12.5 Units on a scale
Interval 0.0 to 50.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with SF-36 data available
Short Form Health Survey (SF-36) is a generic tool to assess overall health status and allows comparison between different diseases. Includes 8 multi-item scales with higher score indicating better health state. The Role Functioning - Emotional Scale includes 3 items assessing extent to which emotional problems interfere with work or other daily activities. Items are transformed to a score with a range of 0-100.
Outcome measures
| Measure |
Metoprolol Succinate
n=265 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=262 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Short Form Health Survey (SF-36) Role Functioning - Emotional Scale
Baseline
|
100.0 Units on a scale
Interval 0.0 to 100.0
|
66.7 Units on a scale
Interval 0.0 to 100.0
|
|
Short Form Health Survey (SF-36) Role Functioning - Emotional Scale
Day 112 visit
|
66.7 Units on a scale
Interval 0.0 to 100.0
|
66.7 Units on a scale
Interval 0.0 to 100.0
|
|
Short Form Health Survey (SF-36) Role Functioning - Emotional Scale
Day 336 Visit
|
66.7 Units on a scale
Interval 0.0 to 100.0
|
66.7 Units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with SF-36 data available
Short Form Health Survey (SF-36) is a generic tool to assess overall health status and allows comparison between different diseases. Includes 8 multi-item scales with higher score indicating better health state. The Energy/Fatigue Scale includes 4 items. Items are transformed to a score with a range of 0-100.
Outcome measures
| Measure |
Metoprolol Succinate
n=265 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=262 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Short Form Health Survey (SF-36) Energy/Fatigue Scale
Baseline
|
50.0 Units on a scale
Interval 35.0 to 60.0
|
50.0 Units on a scale
Interval 35.0 to 60.0
|
|
Short Form Health Survey (SF-36) Energy/Fatigue Scale
Day 112 visit
|
50.0 Units on a scale
Interval 35.0 to 60.0
|
45.0 Units on a scale
Interval 30.0 to 60.0
|
|
Short Form Health Survey (SF-36) Energy/Fatigue Scale
Day 336 Visit
|
50.0 Units on a scale
Interval 35.0 to 60.0
|
45.0 Units on a scale
Interval 30.0 to 55.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with SF-36 data available
Short Form Health Survey (SF-36) is a generic tool to assess overall health status and allows comparison between different diseases. Includes 8 multi-item scales with higher score indicating better health state. The Emotional Well-being Scale includes 5 items assessing emotional wellbeing. Items are transformed to a score with a range of 0-100.
Outcome measures
| Measure |
Metoprolol Succinate
n=265 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=262 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Short Form Health Survey (SF-36) Emotional Well-being Scale
Baseline
|
76.0 Units on a scale
Interval 60.0 to 84.0
|
72.0 Units on a scale
Interval 56.0 to 84.0
|
|
Short Form Health Survey (SF-36) Emotional Well-being Scale
Day 112 visit
|
76.0 Units on a scale
Interval 60.0 to 88.0
|
72.0 Units on a scale
Interval 56.0 to 84.0
|
|
Short Form Health Survey (SF-36) Emotional Well-being Scale
Day 336 Visit
|
76.0 Units on a scale
Interval 60.0 to 88.0
|
72.0 Units on a scale
Interval 56.0 to 84.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with SF-36 data available
Short Form Health Survey (SF-36) is a generic tool to assess overall health status and allows comparison between different diseases. Includes 8 multi-item scales with higher score indicating better health state. The Social Functioning Scale includes 2 items assessing extent to which physical health or emotional problems interfere with normal social activities. Items are transformed to a score with a range of 0-100.
Outcome measures
| Measure |
Metoprolol Succinate
n=265 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=262 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Short Form Health Survey (SF-36) Social Functioning Scale
Baseline
|
62.5 Units on a scale
Interval 50.0 to 87.5
|
62.5 Units on a scale
Interval 50.0 to 87.5
|
|
Short Form Health Survey (SF-36) Social Functioning Scale
Day 112 visit
|
62.5 Units on a scale
Interval 50.0 to 87.5
|
62.5 Units on a scale
Interval 50.0 to 87.5
|
|
Short Form Health Survey (SF-36) Social Functioning Scale
Day 336 Visit
|
75.0 Units on a scale
Interval 50.0 to 87.5
|
62.5 Units on a scale
Interval 37.5 to 87.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with SF-36 data available
Short Form Health Survey (SF-36) is a generic tool to assess overall health status and allows comparison between different diseases. Includes 8 multi-item scales with higher score indicating better health state. The Bodily Pain Scale includes 2 items assessing the intensity of pain and effect of pain on normal work, both inside and outside the house. Items are transformed to a score with a range of 0-100.
Outcome measures
| Measure |
Metoprolol Succinate
n=265 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=262 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Short Form Health Survey (SF-36) Bodily Pain Scale
Baseline
|
67.5 Units on a scale
Interval 45.0 to 90.0
|
67.5 Units on a scale
Interval 45.0 to 90.0
|
|
Short Form Health Survey (SF-36) Bodily Pain Scale
Day 112 visit
|
67.5 Units on a scale
Interval 45.0 to 90.0
|
67.5 Units on a scale
Interval 45.0 to 90.0
|
|
Short Form Health Survey (SF-36) Bodily Pain Scale
Day 336 Visit
|
57.5 Units on a scale
Interval 35.0 to 90.0
|
57.5 Units on a scale
Interval 42.5 to 87.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with SF-36 data available
Short Form Health Survey (SF-36) is a generic tool to assess overall health status and allows comparison between different diseases. Includes 8 multi-item scales with higher score indicating better health state. The General Health Scale includes 4 items assessing personal evaluations of health. Items are transformed to a score with a range of 0-100.
Outcome measures
| Measure |
Metoprolol Succinate
n=265 Participants
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=262 Participants
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Short Form Health Survey (SF-36) General Health Scale
Baseline
|
40.0 Units on a scale
Interval 25.0 to 55.0
|
40.0 Units on a scale
Interval 25.0 to 55.0
|
|
Short Form Health Survey (SF-36) General Health Scale
Day 112 visit
|
40.0 Units on a scale
Interval 25.0 to 55.0
|
35.0 Units on a scale
Interval 25.0 to 55.0
|
|
Short Form Health Survey (SF-36) General Health Scale
Day 336 Visit
|
40.0 Units on a scale
Interval 25.0 to 55.0
|
35.0 Units on a scale
Interval 25.0 to 50.0
|
Adverse Events
Metoprolol Succinate
Placebo
Serious adverse events
| Measure |
Metoprolol Succinate
n=268 participants at risk
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 participants at risk
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.75%
2/268 • Number of events 2 • 1 year
|
0.38%
1/264 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart failure
|
0.75%
2/268 • Number of events 2 • 1 year
|
1.1%
3/264 • Number of events 3 • 1 year
|
|
Cardiac disorders
Stroke
|
0.37%
1/268 • Number of events 1 • 1 year
|
0.38%
1/264 • Number of events 2 • 1 year
|
|
Cardiac disorders
Arrhythmias
|
0.75%
2/268 • Number of events 2 • 1 year
|
0.76%
2/264 • Number of events 2 • 1 year
|
|
Cardiac disorders
Hypotension
|
0.00%
0/268 • 1 year
|
0.38%
1/264 • Number of events 1 • 1 year
|
|
Cardiac disorders
Other Cardiovascular
|
0.37%
1/268 • Number of events 1 • 1 year
|
0.38%
1/264 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
20.5%
55/268 • Number of events 72 • 1 year
|
12.1%
32/264 • Number of events 47 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.2%
14/268 • Number of events 18 • 1 year
|
4.2%
11/264 • Number of events 12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Other Respiratory
|
1.5%
4/268 • Number of events 4 • 1 year
|
0.38%
1/264 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.75%
2/268 • Number of events 3 • 1 year
|
1.9%
5/264 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.75%
2/268 • Number of events 2 • 1 year
|
0.38%
1/264 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.37%
1/268 • Number of events 1 • 1 year
|
0.76%
2/264 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other Cancer
|
0.75%
2/268 • Number of events 2 • 1 year
|
0.38%
1/264 • Number of events 1 • 1 year
|
|
Infections and infestations
Infections, non-pneumonia
|
0.00%
0/268 • 1 year
|
0.76%
2/264 • Number of events 3 • 1 year
|
|
Ear and labyrinth disorders
Head, eyes, ears, nose and throat
|
0.37%
1/268 • Number of events 1 • 1 year
|
0.38%
1/264 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Trauma/Falls
|
0.75%
2/268 • Number of events 2 • 1 year
|
0.76%
2/264 • Number of events 2 • 1 year
|
|
Nervous system disorders
Neurologic, non-stroke
|
0.37%
1/268 • Number of events 1 • 1 year
|
0.38%
1/264 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Psychiatric
|
0.37%
1/268 • Number of events 1 • 1 year
|
0.00%
0/264 • 1 year
|
|
Cardiac disorders
Chest Pain, not otherwise specified
|
0.37%
1/268 • Number of events 1 • 1 year
|
0.38%
1/264 • 1 year
|
|
Endocrine disorders
Endocrine
|
0.37%
1/268 • Number of events 1 • 1 year
|
0.00%
0/264 • 1 year
|
|
General disorders
Other
|
0.75%
2/268 • Number of events 2 • 1 year
|
0.76%
2/264 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
Metoprolol Succinate
n=268 participants at risk
Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).
Metoprolol succinate: Extended release Metoprolol succinate
|
Placebo
n=264 participants at risk
Matched placebo
Placebo: Matching placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
42.9%
115/268 • Number of events 205 • 1 year
|
46.2%
122/264 • Number of events 209 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
7.5%
20/268 • Number of events 25 • 1 year
|
7.2%
19/264 • Number of events 24 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute Sinusitis
|
6.3%
17/268 • Number of events 21 • 1 year
|
3.8%
10/264 • Number of events 12 • 1 year
|
|
General disorders
Headache
|
6.7%
18/268 • Number of events 21 • 1 year
|
5.7%
15/264 • Number of events 16 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
9.0%
24/268 • Number of events 29 • 1 year
|
11.4%
30/264 • Number of events 36 • 1 year
|
|
General disorders
Dizziness
|
8.6%
23/268 • Number of events 27 • 1 year
|
6.1%
16/264 • Number of events 17 • 1 year
|
|
Infections and infestations
Respiratory Infections
|
11.2%
30/268 • Number of events 34 • 1 year
|
8.7%
23/264 • Number of events 30 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place