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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Copd
• Intervention / Treatment: Drug: Nebivolol Tablets

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: asma suliman, bachelor; Phone Number: 00201006279989; Email: asma.shain2017@gmail.com
• Study Contact Backup: Name: marwa adel, associated professor; Phone Number: 00201006383120; Email: dr.marwa.adel2016@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Enrolling by invitation
    • Chest Department, Ain Shams University Hospitals, Cairo, Egypt.
  • Cairo, Egypt
    • Not yet recruiting
    • Chest Department, Ain Shams University Hospitals
    • Contact: gamal A-rhahman, professor
  • Cairo, Egypt
    • Recruiting
    • Chest Department, Ain Shams University Hospitals
    • Contact: gamal A-rhahman, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Drug: Nebivolol Tablets; cardio selective beta-1 blocker
Active Comparator: 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	Drug: Nebivolol Tablets; cardio selective beta-1 blocker

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 15, 2021
• Study Completion (Anticipated): January 15, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 10, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: beta blockers -nebivolol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-1 Receptor Agonists; Nebivolol
• Other Study ID Numbers: beta blockers in copd

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No