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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

Tracking Information
First Submitted Date  ICMJE March 29, 2021
First Posted Date  ICMJE April 14, 2021
Last Update Posted Date April 14, 2021
Estimated Study Start Date  ICMJE October 1, 2021
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2021)
  • 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)
  • forced expiratory volume in one second [ Time Frame: 3 month ]
    volume of air exhaled under condition in the first second (FEV1\liter)
  • blood pressure [ Time Frame: 3 month ]
    BP millimetre mercury
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Copd
Official Title  ICMJE Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Copd
Intervention  ICMJE Drug: Nebivolol Tablets
cardio selective beta-1 blocker
Study Arms  ICMJE
  • 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
    Intervention: Drug: Nebivolol Tablets
  • 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
    Intervention: Drug: Nebivolol Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2022
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: asma suliman, bachelor 00201006279989 asma.shain2017@gmail.com
Contact: marwa adel, associated professor 00201006383120 dr.marwa.adel2016@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04845061
Other Study ID Numbers  ICMJE beta blockers in copd
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Asma Shain Suliman, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP