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

Phase 4

• Conditions: Copd
• Interventions: Drug: Nebivolol Tablets

• Registration Number: NCT04845061
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2021-03-29
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-10
• Last Update Submitted: 2021-04-10
• Study First Posted: 2021-04-14
• Last Update Posted: 2021-04-14
• Study Start: 2021-10-01
• Primary Completion: 2021-12-15
• Study Completion: 2022-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo then nebivolol	Nebivolol Tablets	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
nebivolol then placebo	Nebivolol Tablets	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

Primary Outcome Measures

Name	Time	Method
forced vital capacity	3 months	amount of air that can be forcibly exhaled from the lung after taking the deepest breath possible (FVC\\liter)
forced expiratory volume in one second	3 month	volume of air exhaled under condition in the first second (FEV1\\liter)
blood pressure	3 month	BP millimetre mercury

Trial Locations

Locations (2)

Chest Department, Ain Shams University Hospitals, Cairo, Egypt.; 🇪🇬 Cairo, Egypt

Chest Department, Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt