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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study

Conditions
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Copd

Intervention / Treatment
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* Drug: Nebivolol Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female. informed consent. Age >40years. FEVl/FVC<70%. diagnosed 3 month before enrollment (mild-moderate) Reversability test pre-post bronchodilators FEVl predicted<200ml/hr and less than 12%. Exclusion Criteria: Asthmatic patient. patient already use B blockers. Acute exacerbation. Pregnency -lactation. Advanced cardiac, renal or liver disease according to investigator opinion.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: nebivolol then placebo<br>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 | Drug: Nebivolol Tablets<br>* cardio selective beta-1 blocker<br>|
| Active Comparator: placebo then nebivolol<br>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 | Drug: Nebivolol Tablets<br>* cardio selective beta-1 blocker<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta blockers -nebivolol