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

Ain Shams University

Status and phase: Unknown; Phase 4

Conditions: Copd

Treatments: Drug: Nebivolol Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04845061

beta blockers in copd

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

nebivolol then placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Nebivolol Tablets

placebo then nebivolol

Active Comparator group

Description:

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

Treatment:

Drug: Nebivolol Tablets