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

NCT04845061 | Unknown Phase 4

• 1 other identifier: beta blockers in copd
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Copd

Keywords

beta blockers -nebivolol

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

nebivolol then placebo

PLACEBO COMPARATOR

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

placebo then nebivolol

ACTIVE COMPARATOR

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

Interventions

Nebivolol Tablets DRUG

cardio selective beta-1 blocker

nebivolol then placebo; placebo then nebivolol

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• Asthmatic patient.
• patient already use B blockers.
• Acute exacerbation.
• Pregnency -lactation.
• Advanced cardiac, renal or liver disease according to investigator opinion.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (3)

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

Cairo, Egypt

ENROLLING BY INVITATION

Chest Department, Ain Shams University Hospitals

Cairo, Egypt

NOT YET RECRUITING

Chest Department, Ain Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

asma suliman, bachelor

CONTACT

00201006279989; asma.shain2017@gmail.com

marwa adel, associated professor

CONTACT

00201006383120; dr.marwa.adel2016@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 14, 2021
• Study Start: October 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: January 15, 2022
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

EG (3)