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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1700 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Pragmatic randomized controlled trial|
|Masking:||None (Open Label)|
|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|
Active Comparator: Metoprolol
Metoprolol at an aimed dose of 100 mg in addition to usual standard care
Usual standard care
Drug: Standard care
Other Name: Usual standard care
- Mortality, exacerbations and cardiovascular events [ Time Frame: One year ]A composite measure of all-cause mortality, COPD exacerbations and cardiovascular events after one year
- Mortality [ Time Frame: One year ]All-cause mortality after one year
- Exacerbations [ Time Frame: One year ]Number of COPD exacerbations after one year
- Cardiovascular events [ Time Frame: One year ]Number of cardiovascular events after one year
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
|Contact: Josefin Sundh, MD, PhDfirstname.lastname@example.org|
|Contact: Ole Fröbert, MD, PhDemail@example.com|
|University Hospital of Örebro||Recruiting|
|Örebro, Sweden, 701 85|
|Contact: Josefin Sundh, MD, PhD firstname.lastname@example.org|
|Study Chair:||Ole Fröbert, MD, PhD||Region Örebro County|