Bisoprolol in COPD Study (BICS)

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 20.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; MedDRA version: 20.0Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-002779-24-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-05
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1574

Inclusion Criteria

-Aged = 40 years.
-A smoking history of at least 10 pack years.
-An established predominant diagnosis of COPD (NICE Guideline definition: post bronchodilator FEV1<80% predicted, FEV1/FVC<0.7) receiving treatment as per local guidelines’.
-A history of at least two exacerbations requiring treatment with antibiotics and/or oral corticosteroid use in the previous year, based on patient report.
-Clinically stable with no COPD exacerbation for at least 4 weeks.
-Able to swallow study medication.
-Able and willing to give informed consent to participate.
-Able and willing to participate in the study procedures, complete study questionnaire.
-Able and willing to undergo spirometric assessment, able to perform an FEV1 manoeuvre as a minimum.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 770

Exclusion Criteria

-A current sole respiratory diagnosis of asthma.
-Any diagnosis of asthma before the age of 40 years.
-A predominant respiratory disease other than COPD.
-Any significant disease/disorder which, in the investigator’s opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study.
-Previous allocation of a randomisation code in the study or current participation in another interventional study (CTIMP or non-CTIMP).
-Already taking beta-blocker.
-Known or suspected hypersensitivity to beta-blocker.
-For women, current pregnancy or breast-feeding, or planned pregnancy during the study.
-Unable to perform spirometry (FEV1 manoeuvre).
-Current resting (5 minutes sitting) heart rate <60 bpm.
-Current resting (5 minutes sitting) systolic blood pressure <100mmHg.
-2nd, 3rd degree heart block on ECG (unless pacemaker in situ).
-Conditions for which beta-blocker use is a guideline recommendation, i.e. heart failure, or within the last year: myocardial infarction, acute coronary syndrome.
-Current tachyarrythmia or bradyarrhythmia (including sick sinus syndrome, sinoatrial block) requiring treatment.
-Current treatment with interacting drugs:
oheart rate limiting drug such as calcium channel blockers (diltiazem, verapamil), ivabradine,
oclass-I antiarrhythmic drugs (e.g. quinidine, disopyramide; lidocaine, phenytoin; flecainide, propafenone),
ocentrally-acting antihypertensive drugs (e.g. clonidine methyldopa, moxonidine, rilmenidine).
-Severe peripheral arterial occlusive disease, severe forms of Raynauds syndrome.
-Conditions that are known to be triggered by beta-blockers or beta-blocker withdrawal including myasthenia gravis, periodic hypokalaemic paralysis, pheochromocytoma, thyrotoxicosis and psoriasis/history of psoriasis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified