A Combination of an Inhaled Budesonide and Ipratropium in Patients at Risk of Developing ARDS

Summary

Acute respiratory distress syndrome (ARDS) is a severe lung condition with high morbidity and mortality, despite advances in medical care. It involves an intense inflammatory response in the lungs, leading to endothelial damage, increased capillary permeability, and fluid accumulation, causing hypoxemia and respiratory failure. ARDS can result from various pulmonary and non-pulmonary triggers.

The 2012 Berlin criteria are widely used to diagnose ARDS, based on clinical signs, blood gas analysis, and chest imaging. The Lung Injury Prediction Score (LIPS) is used in emergency departments to assess the risk of ARDS, with scores of 4 or higher indicating a significant risk. Oxygenation impairment, particularly measured by the S/F ratio (oxygen saturation to inspired oxygen), is a strong predictor of ARDS. Common causes of death include severe hypoxemia, sepsis, organ failure, and respiratory complications.

ARDS treatment emphasizes supportive care, including lung-protective ventilation, prone positioning, and conservative fluid management. Pharmacological approaches have shown mixed results, with treatments like statins, surfactants, anticoagulants, and β2-agonists (e.g., salbutamol) offering inconsistent benefits.

Corticosteroids have demonstrated improvements in oxygenation in conditions that progress to ARDS. Inhaled corticosteroids are being explored to minimize systemic side effects by targeting the lungs directly. Ipratropium bromide, an inhaled bronchodilator, may also offer therapeutic benefits by reducing lung inflammation and pulmonary edema. However, it carries risks such as dry mouth, blurred vision, and potential cardiovascular side effects.

This double-blinded randomized controlled trial examines the effectiveness of early inhaled corticosteroids and ipratropium in reducing the risk of acute respiratory distress syndrome (ARDS) and its complications in high-risk patients. Participants will be administered aerosolized budesonide and ipratropium or a placebo every eight hours for five days. The primary outcome is the change in the oxygen saturation to inspired oxygen fraction ratio (S/F) after five days, assessing pulmonary oxygenation. Secondary outcomes include the incidence of ARDS, need for mechanical ventilation, length of hospital stay, and mortality. The study aims to evaluate whether early inhaled therapy can effectively prevent or alleviate ARDS, given the limited availability of pharmacological treatments for the condition.

Conditions

• ARDS
• Prevention and Control

Interventions

DRUG

combined standard aerosolized doses of budesonide (0.5 mg/2 mL) every 12 hours and ipratropium bromide (500/2 mL) every eight hours for up to five days

combined standard aerosolized doses of budesonide (0.5 mg/2 mL) every 12 hours and ipratropium bromide (500/2 mL) every eight hours for up to five days

DRUG

Placebo

Saline inhaler

Sponsors & Collaborators

• Badr University

  collaborator OTHER

• Damanhour University

  lead OTHER

Principal Investigators

• amira B kassem · Damanhour University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2025-01-01

Completion

2025-01-01

Countries

• Egypt

Study Locations