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

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ClinicalTrials.gov Identifier: NCT04845061
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Asma Shain Suliman, 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.


Condition or disease Intervention/treatment Phase
Copd Drug: Nebivolol Tablets Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. forced vital capacity [ Time Frame: 3 months ]
    amount of air that can be forcibly exhaled from the lung after taking the deepest breath possible (FVC\liter)

  2. forced expiratory volume in one second [ Time Frame: 3 month ]
    volume of air exhaled under condition in the first second (FEV1\liter)

  3. blood pressure [ Time Frame: 3 month ]
    BP millimetre mercury



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845061


Contacts
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Contact: asma suliman, bachelor 00201006279989 asma.shain2017@gmail.com
Contact: marwa adel, associated professor 00201006383120 dr.marwa.adel2016@gmail.com

Locations
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Egypt
Chest Department, Ain Shams University Hospitals, Cairo, Egypt. Enrolling by invitation
Cairo, Egypt
Chest Department, Ain Shams University Hospitals Not yet recruiting
Cairo, Egypt
Contact: gamal A-rhahman, professor         
Chest Department, Ain Shams University Hospitals Recruiting
Cairo, Egypt
Contact: gamal A-rhahman, professor         
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Asma Shain Suliman, Clinical pharmacist, Ain Shams University
ClinicalTrials.gov Identifier: NCT04845061    
Other Study ID Numbers: beta blockers in copd
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asma Shain Suliman, Ain Shams University:
beta blockers -nebivolol
Additional relevant MeSH terms:
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Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs