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CompletedNCT07866989Updated Oct 9, 2026

Nebulized Verapamil in COPD Exacerbations

An interventional study of Verapamil hydrochloride and Conventional treatment in Chronic Obstructive Pulmonary Disease and Acute Exacerbation of Chronic Obstructive Pulmonary Disease, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 41 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Apr 2023, registered Oct 2026).
Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
41 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

  • Nebulized verapamil
  • Oxygenation
  • Pulmonary function
  • Dyspnea
  • Right ventricular systolic pressure
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
41 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Nebulized Verapamil Plus Conventional Treatment

    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

  • Active comparator
    Conventional Treatment Alone

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

    Other: Conventional treatment

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose

  2. 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.

    Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose

  3. 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.

    Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose

  4. Change in Arterial Blood pH

    Arterial blood pH was measured by arterial blood gas analysis during the 3-day treatment period.

    Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose

  5. 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.

    Time frame: Baseline on Day 1 through Day 3 after the second scheduled dose

Secondary outcomes

  1. 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.

    Time frame: Baseline to Day 3

  2. Change in Forced Vital Capacity (FVC)

    FVC was measured by spirometry in liters before treatment and after completion of the 3-day intervention.

    Time frame: Baseline to Day 3

  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.

    Time frame: Baseline to Day 3

  4. 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.

    Time frame: Baseline to Day 3

  5. 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.

    Time frame: Baseline to Day 3

  6. 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.

    Time frame: Baseline to Day 3

  7. 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.

    Time frame: Baseline to Day 3

07

Study locations

1 site
  • Ain Shams University Hospitals
    Cairo, Cairo Governorate 11511, Egypt
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07866989
Responsible party
Salma Ayman (Resident of Chest Diseases, Ain Shams University) — Principal investigator
First posted
Oct 9, 2026
Start date
Apr 30, 2023
Primary completion
Mar 30, 2024
Completion
Mar 30, 2024
Last update
Oct 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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