Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Copd

NCT ID: NCT04845061

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-01-15

Brief Summary

To Evaluate the Outcome of cardio selective beta1 (β1-) blockers use in patients with chronic obstructive pulmonary disease.

Patient education about the COPD and their medications.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a common preventable and Treatable airway disorder characterized by symptoms such as dyspnea, chronic Cough, and sputum production along with persistent airflow limitation that is not fully Reversible.

Evidence provided by post hoc analysis of clinical trials and large observational studies suggests a beneficial effect of beta-blockers on mortality and exacerbation in mild to moderate COPD patients.

Evidence concerning cardio selective B blockers. Over the past 20 years' non selective B blockers have largely been replaced with cardio selective blockers. Cardio selective beta blockers such as atenolol and metoprolol are at least 20 times more potent at blocking B-1 receptors than B-2 receptors. At therapeutic doses the B-1 blocking effect, and therefore the risk of bronco constriction, is negligible. In addition there is strong evidence that B-blocked cause up-regulation and sensitization of B-receptors.

Conditions

Copd

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

nebivolol then placebo

Comprises15 copd patients, after recruitment in study and written informed consent, patient's administered nebivolol (1.25 mg for one week then2.5mg fore another one week and 5 mg at 8am for 10 weeks)and washout period4 weeks then shifted to placebo for 12 weeks

Group Type: PLACEBO_COMPARATOR

Nebivolol Tablets

Intervention Type: DRUG

cardio selective beta-1 blocker

placebo then nebivolol

Contain 15 copd patient's after recruitment and Written informed consent administered placebo for 12 weeks and washout period for 4 weeks then shifted to nebivolol for 12 weeks

Group Type: ACTIVE_COMPARATOR

Nebivolol Tablets

Intervention Type: DRUG

cardio selective beta-1 blocker

Interventions

Nebivolol Tablets

cardio selective beta-1 blocker

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female.

2. informed consent.

3. Age >40years.

4. FEVl/FVC<70%.

5. diagnosed 3 month before enrollment (mild-moderate)

6. Reversability test pre-post bronchodilators FEVl predicted<200ml/hr and less than 12%.

Exclusion Criteria

1. Asthmatic patient.

2. patient already use B blockers.

3. Acute exacerbation.

4. Pregnency -lactation.

5. Advanced cardiac, renal or liver disease according to investigator opinion.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Asma Shain Suliman

Clinical pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chest Department, Ain Shams University Hospitals, Cairo, Egypt.

Cairo, , Egypt

Site Status: ENROLLING_BY_INVITATION

Chest Department, Ain Shams University Hospitals

Cairo, , Egypt

Site Status: NOT_YET_RECRUITING

Chest Department, Ain Shams University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

asma suliman, bachelor

Role: CONTACT

asma.shain2017@gmail.com

00201006279989

marwa adel, associated professor

Role: CONTACT

dr.marwa.adel2016@gmail.com

00201006383120

Facility Contacts

gamal A-rhahman, professor

Role: primary

gamal A-rhahman, professor

Role: primary

Other Identifiers

beta blockers in copd

Identifier Type: -

Identifier Source: org_study_id