CopdPhase 4NCT04845061
Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Copd
A Phase 4 study testing Nebivolol Tablets in people with Copd, run by Ain Shams University at 3 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Copd
- What is being tested?
- Nebivolol Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Oct 2021to 15 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- Asthmatic patient.
- patient already use B blockers.
- Acute exacerbation.
- Pregnency -lactation.
- Advanced cardiac, renal or liver disease according to investigator opinion.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Enrolling by invitation
Chest Department, Ain Shams University Hospitals, Cairo, Egypt.
Cairo
- Not yet recruiting
Chest Department, Ain Shams University Hospitals
Cairo
gamal A-rhahman, professor
- Recruiting
Chest Department, Ain Shams University Hospitals
Cairo
gamal A-rhahman, professor
About this study
Official title: 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.
Read the 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.
- Conditions
- Copd
- Being tested
- Nebivolol Tablets
- Keywords
- beta blockers -nebivolol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebivolol TabletsDrug
cardio selective beta-1 blocker
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Nebivolol Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity
amount of air that can be forcibly exhaled from the lung after taking the deepest breath possible (FVC\liter)
Measured: 3 months
forced expiratory volume in one second
volume of air exhaled under condition in the first second (FEV1\liter)
Measured: 3 month
blood pressure
BP millimetre mercury
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Oct 2021 (estimated)
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Shain Suliman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845061
- Sponsor's protocol ID
- beta blockers in copd
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT04845061
- Acronym / sponsor ID
- beta blockers in copd
- Conditions
- Copd
- Keywords
- beta blockers -nebivolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nebivolol then placebo | Placebo comparator | Drug: Nebivolol TabletsComprises15 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 |
| placebo then nebivolol | Active comparator | Drug: Nebivolol TabletsContain 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female.
- informed consent.
- Age >40years.
- FEVl/FVC<70%.
- diagnosed 3 month before enrollment (mild-moderate)
Key exclusion criteria (5 listed)
- Asthmatic patient.
- patient already use B blockers.
- Acute exacerbation.
- Pregnency -lactation.
- Advanced cardiac, renal or liver disease according to investigator opinion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebivolol Tabletscardio selective beta-1 blocker | Drug | nebivolol then placebo, placebo then nebivolol |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Copd
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebivolol Tablets in people with Copd, run by Ain Shams University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact asma suliman, bachelor (00201006279989, asma.shain2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.