Chronic Obstructive Pulmonary DiseaseNCT07866989
Nebulized Verapamil in COPD Exacerbations
A study testing Verapamil hydrochloride and Conventional treatment in people with Chronic Obstructive Pulmonary Disease and Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
This clinical trial evaluated whether adding nebulized verapamil to conventional treatment could improve oxygenation and clinical status in patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (COPD). A total of 60 participants were randomly assigned to two groups. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Verapamil hydrochloride and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2023to 30 Mar 2024
- Phase
- Interventional
- 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 40 years
- Male or female
- Diagnosis of acute exacerbation of chronic obstructive pulmonary disease according to GOLD 2023 criteria
- With or without respiratory failure
- Left ventricular ejection fraction greater than 55%
- Right ventricular systolic pressure greater than 30 mmHg
Who cannot join
- Pre-existing cardiac disorders, including severe left ventricular dysfunction
- Arrhythmias
- Heart block
- Hypotension
- Bradycardia
- Known hypersensitivity to verapamil
Show all 12Show fewer
- Requirement for mechanical ventilation
- Interstitial lung disease
- Bronchiectasis
- Pneumonia
- Pulmonary embolism
- Lung cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nebulized Verapamil on Oxygenation in Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Patients
This clinical trial evaluated whether adding nebulized verapamil to conventional treatment could improve oxygenation and clinical status in patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (COPD).
A total of 60 participants were randomly assigned to two groups. One group received nebulized verapamil in addition to conventional treatment, while the other group received conventional treatment alone. Nebulized verapamil was given at a dose of 10 mg twice daily for three consecutive days. The study assessed changes in oxygenation, respiratory function, symptoms, functional status, and cardiovascular safety during the treatment period.
- Conditions
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Being tested
- Verapamil hydrochloride, Conventional treatment
- Keywords
- Nebulized verapamil, Oxygenation, Pulmonary function, Dyspnea, Right ventricular systolic pressure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verapamil hydrochlorideDrug
Verapamil hydrochloride was administered by nebulization at a dose of 10 mg twice daily for 3 consecutive days, for a total of 6 scheduled doses. Each dose was prepared from two 5-mg ampoules at a concentration of 2.5 mg/mL, providing a total volume of 4 mL, and was administered using a compressed-air jet nebulizer.
Conventional treatmentOther
Conventional treatment for acute exacerbation of COPD included antibiotics and bronchodilators and was administered during the 3-day study period.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Verapamil Plus Conventional Treatment | Experimental | Participants received verapamil hydrochloride 10 mg by nebulization twice daily for 3 consecutive days, in addition to conventional treatment. Verapamil was prepared from two 5-mg ampoules at a concentration of 2.5 mg/mL, giving a total volume of 4 mL per dose, and was administered using a compressed-air jet nebulizer. Conventional treatment included antibiotics and bronchodilators. Receives: Drug: Verapamil hydrochloride |
| Conventional Treatment Alone | Active comparator | Participants received conventional treatment alone for 3 consecutive days, including antibiotics and bronchodilators. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation was measured by pulse oximetry. Change in SpO₂ during the 3-day treatment period was compared between the nebulized verapamil and control groups.
Measured: Baseline on Day 1 through Day 3 after the second scheduled dose
Change in Arterial Oxygen Partial Pressure (PaO₂)
Arterial oxygen partial pressure (PaO₂), measured in mmHg by arterial blood gas analysis, was assessed during the 3-day treatment period.
Measured: Baseline on Day 1 through Day 3 after the second scheduled dose
Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂)
Arterial carbon dioxide partial pressure (PaCO₂), measured in mmHg by arterial blood gas analysis, was assessed during the 3-day treatment period.
Measured: Baseline on Day 1 through Day 3 after the second scheduled dose
Change in Arterial Blood pH
Arterial blood pH was measured by arterial blood gas analysis during the 3-day treatment period.
Measured: Baseline on Day 1 through Day 3 after the second scheduled dose
Change in Serum Bicarbonate (HCO₃-)
Bicarbonate concentration (HCO₃-), measured in mmol/L by arterial blood gas analysis, was assessed during the 3-day treatment period.
Measured: Baseline on Day 1 through Day 3 after the second scheduled dose
Secondary outcomes (7)
Change in Forced Expiratory Volume in One Second (FEV₁)
FEV₁ was measured by spirometry in liters before treatment and after completion of the 3-day intervention.
Measured: Baseline to Day 3
Change in Forced Vital Capacity (FVC)
FVC was measured by spirometry in liters before treatment and after completion of the 3-day intervention.
Measured: Baseline to Day 3
Change in FEV₁/FVC Ratio
The ratio of forced expiratory volume in one second to forced vital capacity was measured by spirometry before and after treatment.
Measured: Baseline to Day 3
Change in Maximum Mid-Expiratory Flow at 50% of FVC (MMEF50)
MMEF50 was measured by spirometry before treatment and after completion of the 3-day intervention.
Measured: Baseline to Day 3
Change in Right Ventricular Systolic Pressure (RVSP)
RVSP, measured in mmHg by transthoracic echocardiography, was assessed before treatment and after completion of the 3-day intervention.
Measured: Baseline to Day 3
Change in Modified Borg Dyspnea Score
Dyspnea severity was assessed using the modified Borg scale ranging from 0, indicating no dyspnea, to 10, indicating maximal dyspnea.
Measured: Baseline to Day 3
Change in World Health Organization Functional Class
Functional limitation was assessed using World Health Organization functional class, ranging from Class I, indicating no limitation of physical activity, to Class IV, indicating symptoms at rest and severe functional limitation.
Measured: Baseline to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Apr 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in parallel to either nebulized verapamil plus conventional treatment or conventional treatment alone.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ayman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866989
- Sponsor's protocol ID
- FMASU MD68/2023
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nebulized Verapamil on Oxygenation in Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Patients
- ClinicalTrials.gov ID
- NCT07866989
- Acronym / sponsor ID
- FMASU MD68/2023
- Conditions
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Keywords
- Nebulized verapamil, Oxygenation, Pulmonary function, Dyspnea, Right ventricular systolic pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 9 Oct 2026 (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.
This clinical trial evaluated whether adding nebulized verapamil to conventional treatment could improve oxygenation and clinical status in patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (COPD).
A total of 60 participants were randomly assigned to two groups. One group received nebulized verapamil in addition to conventional treatment, while the other group received conventional treatment alone. Nebulized verapamil was given at a dose of 10 mg twice daily for three consecutive days. The study assessed changes in oxygenation, respiratory function, symptoms, functional status, and cardiovascular safety during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in parallel to either nebulized verapamil plus conventional treatment or conventional treatment alone.
| Arm | Type | Receives |
|---|---|---|
| Nebulized Verapamil Plus Conventional Treatment | Experimental | Drug: Verapamil hydrochlorideParticipants received verapamil hydrochloride 10 mg by nebulization twice daily for 3 consecutive days, in addition to conventional treatment. Verapamil was prepared from two 5-mg ampoules at a concentration of 2.5 mg/mL, giving a total volume of 4 mL per dose, and was administered using a compressed-air jet nebulizer. Conventional treatment included antibiotics and bronchodilators. |
| Conventional Treatment Alone | Active comparator | Other: Conventional treatmentParticipants received conventional treatment alone for 3 consecutive days, including antibiotics and bronchodilators. |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age older than 40 years
- Male or female
- Diagnosis of acute exacerbation of chronic obstructive pulmonary disease according to GOLD 2023 criteria
- With or without respiratory failure
- Left ventricular ejection fraction greater than 55%
Key exclusion criteria (12 listed)
- Pre-existing cardiac disorders, including severe left ventricular dysfunction
- Arrhythmias
- Heart block
- Hypotension
- Bradycardia
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 |
|---|---|---|
| Verapamil hydrochlorideVerapamil hydrochloride was administered by nebulization at a dose of 10 mg twice daily for 3 consecutive days, for a total of 6 scheduled doses. Each dose was prepared from two 5-mg ampoules at a concentration of 2.5 mg/mL, providing a total volume of 4 mL, and was administered using a compressed-air jet nebulizer. | Drug | Nebulized Verapamil Plus Conventional Treatment |
| Conventional treatmentConventional treatment for acute exacerbation of COPD included antibiotics and bronchodilators and was administered during the 3-day study period. | Other | Conventional Treatment Alone |
Primary outcome
Change in Peripheral Oxygen Saturation (SpO₂)
Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose
Peripheral oxygen saturation was measured by pulse oximetry. Change in SpO₂ during the 3-day treatment period was compared between the nebulized verapamil and control groups.
Change in Arterial Oxygen Partial Pressure (PaO₂)
Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose
Arterial oxygen partial pressure (PaO₂), measured in mmHg by arterial blood gas analysis, was assessed during the 3-day treatment period.
Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂)
Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose
Arterial carbon dioxide partial pressure (PaCO₂), measured in mmHg by arterial blood gas analysis, was assessed during the 3-day treatment period.
Change in Arterial Blood pH
Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose
Arterial blood pH was measured by arterial blood gas analysis during the 3-day treatment period.
Change in Serum Bicarbonate (HCO₃-)
Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose
Bicarbonate concentration (HCO₃-), measured in mmol/L by arterial blood gas analysis, was assessed during the 3-day treatment period.
7 secondary outcomes
Change in Forced Expiratory Volume in One Second (FEV₁)
Time frame: Baseline to Day 3
Change in Forced Vital Capacity (FVC)
Time frame: Baseline to Day 3
Change in FEV₁/FVC Ratio
Time frame: Baseline to Day 3
Change in Maximum Mid-Expiratory Flow at 50% of FVC (MMEF50)
Time frame: Baseline to Day 3
Change in Right Ventricular Systolic Pressure (RVSP)
Time frame: Baseline to Day 3
Change in Modified Borg Dyspnea Score
Time frame: Baseline to Day 3
Change in World Health Organization Functional Class
Time frame: Baseline to Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verapamil hydrochloride and Conventional treatment in people with Chronic Obstructive Pulmonary Disease and Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Ain Shams University at 1 site 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 12 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peripheral Oxygen Saturation (SpO₂) (time frame: Baseline on Day 1 through Day 3 after the second scheduled dose). The study lists 5 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 9 Oct 2026.