Chronic Obstructive Pulmonary Disease, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Nebulized verapamil, Oxygenation, Pulmonary function, Dyspnea, Right ventricular systolic pressure
Brief 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. 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.
Interventions
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.
OTHERConventional treatment
Conventional treatment for acute exacerbation of COPD included antibiotics and bronchodilators and was administered during the 3-day study period.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned in parallel to either nebulized verapamil plus conventional treatment or conventional treatment alone.
Eligibility
Sex/Gender
ALL
Age
41 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Pre-existing cardiac disorders, including severe left ventricular dysfunction * Arrhythmias * Heart block * Hypotension * Bradycardia * Known hypersensitivity to verapamil * Requirement for mechanical ventilation * Interstitial lung disease * Bronchiectasis * Pneumonia * Pulmonary embolism * Lung cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peripheral Oxygen Saturation (SpO₂) | 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) | 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) | 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 | 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-) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Expiratory Volume in One Second (FEV₁) | Baseline to Day 3 | FEV₁ was measured by spirometry in liters before treatment and after completion of the 3-day intervention. |
| Change in Forced Vital Capacity (FVC) | Baseline to Day 3 | FVC was measured by spirometry in liters before treatment and after completion of the 3-day intervention. |
| Change in FEV₁/FVC Ratio | Baseline to Day 3 | The ratio of forced expiratory volume in one second to forced vital capacity was measured by spirometry before and after treatment. |
| Change in Maximum Mid-Expiratory Flow at 50% of FVC (MMEF50) | Baseline to Day 3 | MMEF50 was measured by spirometry before treatment and after completion of the 3-day intervention. |
| Change in Right Ventricular Systolic Pressure (RVSP) | Baseline to Day 3 | RVSP, measured in mmHg by transthoracic echocardiography, was assessed before treatment and after completion of the 3-day intervention. |
| Change in Modified Borg Dyspnea Score | Baseline to Day 3 | Dyspnea severity was assessed using the modified Borg scale ranging from 0, indicating no dyspnea, to 10, indicating maximal dyspnea. |
| Change in World Health Organization Functional Class | Baseline to Day 3 | 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. |
Countries
Egypt
Outcome results
None listed