Beta-Blockers for the Prevention of Acute Exacerbations o... | NCT02587351

Status Module

Name	Class
United States Department of Defense	FED
University of Alabama at Birmingham	OTHER

Description Module

Label	Type	Description	Intervention Names
Metoprolol succinate	Active Comparator	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).	Drug: Metoprolol succinate
Placebo	Placebo Comparator	Matched placebo	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Metoprolol succinate	Drug	Extended release Metoprolol succinate	Metoprolol succinate

Measure	Description	Time Frame
Time to First Occurrence of an Acute COPS Exacerbation	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".	1 year

Measure	Description	Time Frame
Number of Acute Exacerbations of COPD	Number of acute exacerbations of COPD - rate per person-year	1 year
Number of Emergency Department Visits Resulting From Acute Exacerbations of COPD	Number of Emergency Department visits resulting from acute exacerbations of COPD - rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects, ≥ 40 and less than 85 years of age
Clinical diagnosis of at least moderate COPD as defined by the Global Initiative for Obstructive Lung Disease (GOLD) criteria (53):
- Post bronchodilator FEV1/FVC < 70% (Forced expiratory volume in 1 second/ forced vital capacity),
- Post bronchodilator FEV1 < 80% predicted, with or without chronic symptoms (i.e., cough, sputum production).
Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.
To enrich the population for patients who are more likely to have acute exacerbations (54), each subject must meet one or more of the following 4 conditions:
- Have a history of receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year,
- Visiting an Emergency Department for a COPD exacerbation within the past year, or
- Being hospitalized for a COPD exacerbation within the past year
- Be using or be prescribed supplemental oxygen for 12 or more hours per day
- Willingness to make return visits and availability by telephone for duration of study.

Exclusion Criteria:

A diagnosis of asthma established by each study investigator on the basis of the recent American Thoracic Society/European Respiratory Society and National Institute for Health and Care Excellence guidelines.
The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy < 2 years.
Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study.
Current tachy or brady arrhythmias requiring treatment
Presence of a pacemaker and/or internal cardioverter/defibrillator
Patients with a history of second or third degree (complete) heart block, or sick sinus syndrome
Baseline EKG revealing left bundle branch block, bifascicular block, ventricular tachyarrhythmia, atrial fibrillation, atrial flutter, supraventricular tachycardia (other than sinus tachycardia and multifocal atrial tachycardia), or heart block (2nd degree or complete)
Resting heart rate less than 65 beats per minute, or sustained resting tachycardia defined as heart rate greater than 120 beats per minute.
Resting systolic blood pressure of less than 100mm Hg.
Subjects with absolute (Class 1) indications for beta-blocker treatment as defined by the combined American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons Guidelines which include myocardial infarction, acute coronary syndrome, percutaneous coronary intervention or coronary artery bypass surgery within the prior 3 years and patients with known congestive heart failure defined as left ventricular ejection fraction <40%.(29, 30)
Critical ischemia related to peripheral arterial disease.
Other diseases that are known to be triggered by beta-blockers or beta-blocker withdrawal including myasthenia gravis, periodic hypokalemic paralysis, pheochromocytoma, and thyrotoxicosis
Patients on other cardiac medications known to cause atrioventricular (AV) node conduction delays such as amiodarone, digoxin, and calcium channel blockers including verapamil and diltiazem as well as patients taking clonidine.
Hospitalization for uncontrolled diabetes mellitus or hypoglycemia within the last 12 months.
Patients with cirrhosis
A clinical diagnosis of bronchiectasis defined as production of > one-half cup of purulent sputum/day.
Patients otherwise meeting the inclusion criteria will not be enrolled until they are a minimum of four weeks from their most recent acute exacerbation (i.e., they will not have received a course of systemic corticosteroids, an increased dose of chronically administered systemic corticosteroids, and/or antibiotics for an acute exacerbation for a minimum of four weeks).

Name	Affiliation	Role
Mark Dransfield, MD	University of Alabama at Birmingham	Principal Investigator
John Connett, PhD	University of Minnesota	Principal Investigator
Stephen Lazarus, MD	University of California, San Francisco	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham, Alabama VA Medical		Birmingham	Alabama	35233	United States
University of Alabama at Birmingham

PubMed Identifier	Type	Citation	Retractions
35363600	Derived	Parekh TM, Helgeson ES, Connett J, Voelker H, Ling SX, Lazarus SC, Bhatt SP, MacDonald DM, Mkorombindo T, Kunisaki KM, Fortis S, Kaminsky D, Dransfield MT. Lung Function and the Risk of Exacerbation in the beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1642-1649. doi: 10.1513/AnnalsATS.202109-1042OC.
31633896

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 12, 2017

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.2± 7.6 BG00164.8± 7.9 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000124 BG001123 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000178 BG001194 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000268 BG001264 BG002

FEV1 after bronchodilation - % of predicted value

Mean

Standard Deviation

% of predicted value

Title

Denominators

Categories

Title	Measurements
	BG00041.3± 16.3 BG00140.8± 16.2 BG002

FEV1:FVC ratio - %

Mean

Standard Deviation

ratio %

Title

Denominators

Categories

Title	Measurements
	BG00044.2± 11.7 BG00145.2± 21.6 BG002

Smoking history No. of pack-yr

Mean

Standard Deviation

pack-years

Title

Denominators

Categories

Title	Measurements
	BG00050.7± 28.7 BG00149.5± 29.6 BG002

Systolic Blood pressure - mm Hg

Mean

Standard Deviation

mm Hg

Title

Denominators

Categories

Title	Measurements
	BG000128.4± 16.5 BG001130.6± 15.9 BG002

Diastolic Blood pressure - mm Hg

Mean

Standard Deviation

mm Hg

Title

Denominators

Categories

Title	Measurements
	BG00077.2± 9.2 BG00176.8± 9.1 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to First Occurrence of an Acute COPS Exacerbation

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".

Posted

Mean

95% Confidence Interval

days

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000268 OG001264

Title

Denominators

Categories

Title	Measurements
	OG000202(162 to 282) OG001222(189 to 295)

Secondary

Number of Acute Exacerbations of COPD

Number of acute exacerbations of COPD - rate per person-year

Posted

Mean

95% Confidence Interval

no. of events/person-yr

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Number of Emergency Department Visits Resulting From Acute Exacerbations of COPD

Number of Emergency Department visits resulting from acute exacerbations of COPD - rate

Posted

Mean

95% Confidence Interval

events per person-year

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Number of Hospital Admissions Resulting From Acute Exacerbations of COPD

Number of hospital admissions resulting from acute exacerbations of COPD - rate

Posted

Mean

95% Confidence Interval

events per person-year

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Hospital Days Resulting From Acute Exacerbations of COPD

Number of hospital days resulting from acute exacerbations of COPD reported as negative binomial estimates of mean hospital days per patient year.

Posted

Mean

95% Confidence Interval

hospital days

14 months

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Major Adverse Cardiovascular Events

Major 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

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

All-cause Mortality

All-cause mortality count

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Incidence of Presumed Metoprolol-related Side-effects

New 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).

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Modified Medical Research Council Dyspnea Scale (MMRC)

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.

Participants with data at baseline and visit day 336

Posted

Median

Inter-Quartile Range

score on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Change in FEV1 % Predicted from baseline to visit day 336 as assessed by spirometry

Participants with data at baseline and visit day 336

Posted

Mean

95% Confidence Interval

percentage of predicted

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Exercise Capacity as Assessed by the 6 Minute Walk Distance (6MWD)

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.

Participants with data at baseline and visit day 336

Posted

Mean

95% Confidence Interval

meters

Baseline, 1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Markers of Systemic Inflammation

Fibrinogen: 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.

Posted

Mean

Standard Deviation

mg/dL

Baseline, 1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

St. George's Respiratory Questionnaire (SGRQ)

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.

Participants with data at baseline and visit day 336

Posted

Mean

95% Confidence Interval

score on a scale

Baseline, 1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

COPD Assessment Test (CAT)

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.

Participants with data at baseline and visit day 336

Posted

Mean

95% Confidence Interval

score on a scale

Baseline, 1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

San Diego Shortness of Breath Questionnaire (SOBQ)

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").

Participants with data at baseline and visit day 336

Posted

Mean

95% Confidence Interval

score on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Acute Exacerbations of COPD and MACE

MACE defined by cardiovascular death, hospitalization for myocardial infarction, heart failure, or stroke

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Short Form Health Survey (SF-36) Physical Function Scale

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.

Participants with SF-36 data available

Posted

Median

Inter-Quartile Range

Units on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants

Secondary

Short Form Health Survey (SF-36) Role Functioning - Physical Scale

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.

Participants with SF-36 data available

Posted

Median

Inter-Quartile Range

Units on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants

Secondary

Short Form Health Survey (SF-36) Role Functioning - Emotional Scale

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.

Participants with SF-36 data available

Posted

Median

Inter-Quartile Range

Units on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants

Secondary

Short Form Health Survey (SF-36) Energy/Fatigue Scale

Participants with SF-36 data available

Posted

Median

Inter-Quartile Range

Units on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Short Form Health Survey (SF-36) Emotional Well-being Scale

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.

Participants with SF-36 data available

Posted

Median

Inter-Quartile Range

Units on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Secondary

Short Form Health Survey (SF-36) Social Functioning Scale

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.

Participants with SF-36 data available

Posted

Median

Inter-Quartile Range

Units on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants

Secondary

Short Form Health Survey (SF-36) Bodily Pain Scale

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.

Participants with SF-36 data available

Posted

Median

Inter-Quartile Range

Units on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants

Secondary

Short Form Health Survey (SF-36) General Health Scale

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.

Participants with SF-36 data available

Posted

Median

Inter-Quartile Range

Units on a scale

1 year

ID	Title	Description
OG000	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
OG001	Placebo	Matched placebo Placebo: Matching placebo

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	ICD-10	Systematic Assessment	EG0002 events2 affected268 at risk EG0011 events1 affected264 at risk
Heart failure	Cardiac disorders	ICD-10	Systematic Assessment	EG0002 events2 affected268 at risk EG0013 events3 affected264 at risk
Stroke	Cardiac disorders	ICD-10	Systematic Assessment	EG0001 events1 affected268 at risk EG0012 events1 affected264 at risk
Arrhythmias	Cardiac disorders	ICD-10	Systematic Assessment	EG0002 events2 affected268 at risk EG0012 events2 affected264 at risk
Hypotension	Cardiac disorders	ICD-10	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected264 at risk
Other Cardiovascular	Cardiac disorders	ICD-10	Systematic Assessment	EG0001 events1 affected268 at risk EG0011 events1 affected264 at risk
COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	ICD-10	Systematic Assessment	EG00072 events55 affected268 at risk EG00147 events32 affected264 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	ICD-10	Systematic Assessment	EG00018 events14 affected268 at risk EG00112 events11 affected264 at risk
Other Respiratory	Respiratory, thoracic and mediastinal disorders	ICD-10	Systematic Assessment	EG0004 events4 affected268 at risk EG0011 events1 affected264 at risk
Gastrointestinal	Gastrointestinal disorders	ICD-10	Systematic Assessment	EG0003 events2 affected268 at risk EG0015 events5 affected264 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	ICD-10	Systematic Assessment	EG0002 events2 affected268 at risk EG0011 events1 affected264 at risk
Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	ICD-10	Systematic Assessment	EG0001 events1 affected268 at risk EG0012 events2 affected264 at risk
Other Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	ICD-10	Systematic Assessment	EG0002 events2 affected268 at risk EG0011 events1 affected264 at risk
Infections, non-pneumonia	Infections and infestations	ICD-10	Systematic Assessment	EG0000 events0 affected268 at risk EG0013 events2 affected264 at risk
Head, eyes, ears, nose and throat	Ear and labyrinth disorders	ICD-10	Systematic Assessment	EG0001 events1 affected268 at risk EG0011 events1 affected264 at risk
Trauma/Falls	Injury, poisoning and procedural complications	ICD-10	Systematic Assessment	EG0002 events2 affected268 at risk EG0012 events2 affected264 at risk
Neurologic, non-stroke	Nervous system disorders	ICD-10	Systematic Assessment	EG0001 events1 affected268 at risk EG0011 events1 affected264 at risk
Psychiatric	Psychiatric disorders	ICD-10	Systematic Assessment	EG0001 events1 affected268 at risk EG0010 events0 affected264 at risk
Chest Pain, not otherwise specified	Cardiac disorders	ICD-10	Systematic Assessment	EG0001 events1 affected268 at risk EG0011 affected264 at risk
Endocrine	Endocrine disorders	ICD-10	Systematic Assessment	EG0001 events1 affected268 at risk EG0010 events0 affected264 at risk
Other	General disorders	ICD-10	Systematic Assessment	EG0002 events2 affected268 at risk EG0012 events2 affected264 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	ICD-10	Systematic Assessment	EG000205 events115 affected268 at risk EG001209 events122 affected264 at risk
Shortness of Breath	Respiratory, thoracic and mediastinal disorders	ICD-10	Systematic Assessment	EG00025 events20 affected268 at risk EG00124 events19 affected264 at risk
Acute Sinusitis	Respiratory, thoracic and mediastinal disorders	ICD-10	Systematic Assessment	EG00021 events17 affected268 at risk EG00112 events10 affected264 at risk
Headache	General disorders	ICD-10	Systematic Assessment	EG00021 events18 affected268 at risk EG00116 events15 affected264 at risk
Gastrointestinal symptoms	Gastrointestinal disorders	ICD-10	Systematic Assessment	EG00029 events24 affected268 at risk EG00136 events30 affected264 at risk
Dizziness	General disorders	ICD-10	Systematic Assessment	EG00027 events23 affected268 at risk EG00117 events16 affected264 at risk
Respiratory Infections	Infections and infestations	ICD-10	Systematic Assessment	EG00034 events30 affected268 at risk EG00130 events23 affected264 at risk

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D020005	Propanols
D000588	Amines

ID	Title	Description
BG000	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
BG001	Placebo	Matched placebo Placebo: Matching placebo
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	11	268	86	268	162	268
EG001	Placebo	Matched placebo Placebo: Matching placebo	5	264	59	264	157	264