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Trial record 2 of 7 for:    "Lung Disease" | "Metoprolol"

Beta-blockers to Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT03566667
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ole Frobert, MD, PhD, Region Örebro County

Brief Summary:

Background: In patients with chronic obstructive pulmonary disease (COPD) and concomitant cardiovascular conditions cardio-selective beta-blockers reduce mortality and can be used without significant negative effects on lung function or respiratory symptoms. Observational studies indicate that beta-blocker therapy in COPD even without overt cardiovascular disease, is associated with reduced risk for mortality and COPD exacerbations.

Aim: The overall purpose of our study is to examine the benefit of general beta-blocker therapy on important patient-oriented measures in chronic obstructive pulmonary disease (COPD). Our primary hypothesis that treatment with beta-blockers in patients with COPD and no comorbid heart disease at baseline can prevent a Composite measure of hospitalizations due to cardiovascular diseases, COPD exacerbations and death.

Population: 1700 patients with C OPD. Inclusion criteria are FEV1/FVC < 70, age >40 years and sinus rhythm 50-120/min. Exclusion criteria include hypersensitivity against metoprolol, atrioventricular (AV) block II or II or sick sinus syndrome without pacemaker, atrial fibrillation or flutter, clinical signs of or previously known cardiovascular disease, systolic blood pressure < 90, severe asthma, present beta-blocker therapy or ongoing COPD exacerbation.

Intervention: Metoprolol at a target dose of 100 mg in addition to standard COPD care.

Control: No placebo control. Randomized, pragmatic un-blinded controlled study where the control Group receives standard COPD care.

Outcome: The primary outcome is a composite measure of all-cause mortality, C OPD exacerbations, and cardiovascular events after one year. Endpoint data from Swedish national registries and clinical follow-up.

Importance: Beta-blocker treatment to attenuate morbidity in patients with COPD could have great clinical and social importance at a low cost.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Metoprolol Drug: Standard care Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beta-blockeRs tO patieNts With CHronIc Obstructive puLmonary diseasE
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: Metoprolol
Metoprolol at an aimed dose of 100 mg in addition to usual standard care
Drug: Metoprolol
Betablocker

Standard care
Usual standard care
Drug: Standard care
Standard care
Other Name: Usual standard care




Primary Outcome Measures :
  1. Mortality, exacerbations and cardiovascular events [ Time Frame: One year ]
    A composite measure of all-cause mortality, COPD exacerbations and cardiovascular events after one year


Secondary Outcome Measures :
  1. Mortality [ Time Frame: One year ]
    All-cause mortality after one year

  2. Exacerbations [ Time Frame: One year ]
    Number of COPD exacerbations after one year

  3. Cardiovascular events [ Time Frame: One year ]
    Number of cardiovascular events after one year



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of COPD confirmed by spirometry showing post bronchodilator value of Forced Expiratory Volume in one second (FEV1)//Forced Vital Capacity (FVC) < 70 according to the Global Initiative on Obstructive Pulmonary Disease (GOLD)
  • ≥40 years of age
  • Sinus rhythm ≥50/min and <120 at inclusion

Exclusion Criteria:

  • Known hypersensitivity to metoprolol or related derivatives
  • AV block II or III unless treated with a pacemaker
  • Sinus bradycardia (resting heart rate <50/min)
  • Sick sinus syndrome unless treated with a pacemaker
  • Atrial fibrillation/flutter
  • Clinical signs of or a previous diagnosis of heart failure, angina pectoris, myocardial infarction, cerebrovascular disease or critical peripheral ischemia
  • Systolic blood pressure <90 mmHg
  • Any tachy-arrythmias other than sinus rhythm
  • Sinus tachycardia >120 / min
  • Systolic blood pressure <90 mmHg
  • Severe bronchial asthma
  • Current beta-blocker treatment
  • Inability to provide informed consent
  • Age below 40 years
  • Acute on-going exacerbation of COPD
  • Previous randomization in the BRONCHIOLE trial
  • Ongoing pregnancy (excluded by pregnancy test in fertile women)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566667


Contacts
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Contact: Josefin Sundh, MD, PhD +46702349517 josefin.sundh@regionorebrolan.se
Contact: Ole Fröbert, MD, PhD +46196021111 ole.frobert@regionorebrolan.se

Locations
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Sweden
University Hospital of Örebro Recruiting
Örebro, Sweden, 701 85
Contact: Josefin Sundh, MD, PhD       josefin.sundh@regionorebrolan.se   
Sponsors and Collaborators
Ole Frobert, MD, PhD
Investigators
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Study Chair: Ole Fröbert, MD, PhD Region Örebro County

Publications of Results:
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Responsible Party: Ole Frobert, MD, PhD, Professor, Region Örebro County
ClinicalTrials.gov Identifier: NCT03566667     History of Changes
Other Study ID Numbers: BRONCHIOLE-2017
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ole Frobert, MD, PhD, Region Örebro County:
Beta-blockers
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Metoprolol
Respiratory Tract Diseases
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action