Nebulized Verapamil in COPD Exacerbations

NCT07866989 | Completed

• 1 other identifier: FMASU MD68/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

Nebulized verapamil; Oxygenation; Pulmonary function; Dyspnea; Right ventricular systolic pressure

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline on Day 1 through Day 3 after the second scheduled dose

Secondary Outcomes (7)

• Change in Forced Expiratory Volume in One Second (FEV₁)

  Baseline to Day 3

• Change in Forced Vital Capacity (FVC)

  Baseline to Day 3

• Change in FEV₁/FVC Ratio

  Baseline to Day 3

• Change in Maximum Mid-Expiratory Flow at 50% of FVC (MMEF50)

  Baseline to Day 3

• Change in Right Ventricular Systolic Pressure (RVSP)

  Baseline to Day 3

Study Arms (2)

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.

Drug: Verapamil hydrochloride

Conventional Treatment Alone

ACTIVE COMPARATOR

Participants received conventional treatment alone for 3 consecutive days, including antibiotics and bronchodilators.

Other: Conventional treatment

Interventions

Verapamil hydrochloride DRUG

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.

Nebulized Verapamil Plus Conventional Treatment

Conventional treatment OTHER

Conventional treatment for acute exacerbation of COPD included antibiotics and bronchodilators and was administered during the 3-day study period.

Conventional Treatment Alone

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Chest Diseases

Model Details: Participants were randomly assigned in parallel to either nebulized verapamil plus conventional treatment or conventional treatment alone.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start: April 30, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

EG (1)