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

NCT06657079 | Completed Phase 1 DMC

• 2 other identifiers: Budesonide-Ipratropium ARDSDamanhour University
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ARDS; Inhaled Budesonide; Inhaled Ipratropium

Outcome Measures

Primary Outcomes (1)

• The primary outcome was longitudinal change in the S/F

  change in the S/F for up to 5 days

Secondary Outcomes (1)

• progression to ARDS

  Through the ICU stay up to 28 day

Study Arms (2)

combined standard aerosolized doses of budesonide (0.5 mg/2 mL) and ipratropium bromide (500/2 mL)

ACTIVE COMPARATOR

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: 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

placebo (4 mL normal saline)

PLACEBO COMPARATOR

placebo (4 mL normal saline)

Drug: Placebo

Interventions

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

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) and ipratropium bromide (500/2 mL)

Placebo DRUG

Saline inhaler

placebo (4 mL normal saline)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years or older)
• Admitted through the ED with at least one known risk factor for ARDS
• A LIPS greater than or equal to 4, and acute hypoxemia (defined as at least 2 L/min of supplemental oxygen requirement to maintain an oxygen saturation between 92% and 98%).

You may not qualify if:

• Pregnant patients
• Inability to obtain consent within 12 hours of hospital presentation
• Indications or contraindications for either corticosteroids or ipratropium (allergy to either budesonide and/or ipratropium bromide use
• History of asthma or chronic obstructive lung disease
• ECG and/or clinical presentation suggestive of acute coronary ischemia
• A new cardiac arrhythmia including atrial fibrillation
• Uncontrolled atrial fibrillation; or persistent sinus tachycardia of \>130/minute
• Receipt of inhaled muscarinic antagonist or corticosteroids in prior 7 days
• Systemic steroid treatment on admission or within 7 days prior to admission equivalent to more than 5 mg of prednisone daily
• Onset of ARDS (by Berlin criteria including noninvasive ventilation) prior to enrollment

Sponsors & Collaborators

• Damanhour University: lead
• Badr University: collaborator

Study Sites (1)

Mashtoul El Souq governmental hospital (50 beds), Sharkia, Egypt

Cairo, Egypt

Location

MeSH Terms

Interventions

Ipratropium

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• amira B kassem

  Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 24, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

EG (1)