ARDSPhase 1/2BUDIPRA-ARDSNCT06657079
A Combination of an Inhaled Budesonide and Ipratropium in Patients at Risk of Developing ARDS
A Phase 1/2 study testing 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 in people with ARDS and Prevention and Control, run by Damanhour University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Prevention and Control
- What is being tested?
- 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mashtoul El Souq governmental hospital (50 beds), Sharkia, Egypt
Cairo
About this study
Official title: A Combination of an Inhaled Budesonide and Ipratropium in Patients at Risk of Developing Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
ARDS is a severe form of lung injury that continues to present high morbidity and mortality rates despite progress in diagnostic and therapeutic approaches. It is characterized by an intense inflammatory response in the lungs, leading to damage to the pulmonary endothelial and epithelial layers, increased permeability, and the development of pulmonary edema. These changes result in severe hypoxemia and acute respiratory failure. ARDS can be triggered by various factors, including pulmonary and non-pulmonary injuries.
Diagnosing ARDS is challenging due to the lack of a single definitive test. The Berlin criteria, which encompass clinical presentation, arterial blood gas analysis (PF ratio), and chest imaging, are widely utilized. The Lung Injury Prediction Score (LIPS) assists in evaluating ARDS risk, with a score of 4 or higher indicating increased likelihood.
Major causes of mortality in ARDS include persistent hypoxemia, sepsis, multiple organ failure, and respiratory failure. The management of ARDS primarily focuses on supportive care with the goal of mitigating lung injury by addressing underlying causes. Key strategies include employing lung-protective ventilation, prone positioning, and conservative fluid management. Pharmacologic treatments for ARDS have generally been unsuccessful in improving survival rates. Trials of therapies such as statins, aspirin, and vitamin D supplementation have not shown significant improvements in ARDS outcomes. β2-agonists have been investigated for their potential to enhance alveolar fluid clearance, but results have been inconsistent.
Corticosteroids have shown potential in improving oxygenation and histologic lung injury in ARDS. To maximize benefits while minimizing risks, corticosteroids should be administered within the first 14 days of ARDS diagnosis. Inhaled corticosteroids and ipratropium bromide are being explored as treatments for ARDS due to their targeted action on the respiratory system and reduced systemic side effects. Inhaled budesonide has shown potential in improving lung function and cytokine profiles. Ipratropium bromide, a short-acting anticholinergic bronchodilator, helps relax smooth muscles in the respiratory tract and is used in mechanically ventilated patients.
This study aims to assess the efficacy of inhaled corticosteroids and ipratropium bromide, in combination with standard care, in improving oxygenation, reducing ARDS incidence, minimizing the need for mechanical ventilation, shortening hospital stays, and lowering mortality rates. The potential benefits of these therapies in the prevention and management of ARDS are under investigation.
This study was structured as a double-blind, randomized clinical trial. It will be conducted in the ICU of a governmental hospital. Eligible participants are adults aged 18 years or older admitted through the emergency department. All participants will have least one risk factor for ARDS, a Lung Injury Prediction Score (LIPS) of 4 or more. Exclusion criteria includes pregnant patients, those unable to provide consent within 12 hours of hospital admission, or individuals with contraindications to corticosteroids or ipratropium, patients who had used inhaled corticosteroids or muscarinic antagonists within the past 7 days, had ARDS onset prior to enrollment, or required mechanical ventilation before admission. Those with an expected hospital stay of less than 48 hours, poor prognosis, or admitted for palliative care will not be included in the trial. Participants will be randomized in a 1:1 ratio within 12 hours of presentation. This trial was approved by the BUC-Institutional Ethical Committee (No. BUC-IACUC-240318-80). All patients agree to participation will sign a participation consent.
- Conditions
- ARDS, Prevention and Control
- Being tested
- 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
- Keywords
- ARDS, Inhaled Budesonide, Inhaled Ipratropium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 daysDrug
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
PlaceboDrug
Saline inhaler
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was longitudinal change in the S/F
Measured: change in the S/F for up to 5 days
Secondary outcomes (1)
progression to ARDS
Final diagnosis of ARDS was determined using Berlin criteria after chest radiograph.
- Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R,
Measured: Through the ICU stay up to 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 May 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Badr University
- Responsible party
- Sponsor
- Investigators
- amira B kassem, Principal investigator, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657079
- Sponsor's protocol ID
- Budesonide-Ipratropium ARDS
- Other IDs
- Damanhour University
- Acronym
- BUDIPRA-ARDS
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of an Inhaled Budesonide and Ipratropium in Patients at Risk of Developing Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06657079
- Acronym / sponsor ID
- BUDIPRA-ARDS / Budesonide-Ipratropium ARDS
- Conditions
- ARDS, Prevention and Control
- Keywords
- ARDS, Inhaled Budesonide, Inhaled Ipratropium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Badr University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ARDS is a severe form of lung injury that continues to present high morbidity and mortality rates despite progress in diagnostic and therapeutic approaches. It is characterized by an intense inflammatory response in the lungs, leading to damage to the pulmonary endothelial and epithelial layers, increased permeability, and the development of pulmonary edema. These changes result in severe hypoxemia and acute respiratory failure. ARDS can be triggered by various factors, including pulmonary and non-pulmonary injuries.
Diagnosing ARDS is challenging due to the lack of a single definitive test. The Berlin criteria, which encompass clinical presentation, arterial blood gas analysis (PF ratio), and chest imaging, are widely utilized. The Lung Injury Prediction Score (LIPS) assists in evaluating ARDS risk, with a score of 4 or higher indicating increased likelihood.
Major causes of mortality in ARDS include persistent hypoxemia, sepsis, multiple organ failure, and respiratory failure. The management of ARDS primarily focuses on supportive care with the goal of mitigating lung injury by addressing underlying causes. Key strategies include employing lung-protective ventilation, prone positioning, and conservative fluid management. Pharmacologic treatments for ARDS have generally been unsuccessful in improving survival rates. Trials of therapies such as statins, aspirin, and vitamin D supplementation have not shown significant improvements in ARDS outcomes. β2-agonists have been investigated for their potential to enhance alveolar fluid clearance, but results have been inconsistent.
Corticosteroids have shown potential in improving oxygenation and histologic lung injury in ARDS. To maximize benefits while minimizing risks, corticosteroids should be administered within the first 14 days of ARDS diagnosis. Inhaled corticosteroids and ipratropium bromide are being explored as treatments for ARDS due to their targeted action on the respiratory system and reduced systemic side effects. Inhaled budesonide has shown potential in improving lung function and cytokine profiles. Ipratropium bromide, a short-acting anticholinergic bronchodilator, helps relax smooth muscles in the respiratory tract and is used in mechanically ventilated patients.
This study aims to assess the efficacy of inhaled corticosteroids and ipratropium bromide, in combination with standard care, in improving oxygenation, reducing ARDS incidence, minimizing the need for mechanical ventilation, shortening hospital stays, and lowering mortality rates. The potential benefits of these therapies in the prevention and management of ARDS are under investigation.
This study was structured as a double-blind, randomized clinical trial. It will be conducted in the ICU of a governmental hospital. Eligible participants are adults aged 18 years or older admitted through the emergency department. All participants will have least one risk factor for ARDS, a Lung Injury Prediction Score (LIPS) of 4 or more. Exclusion criteria includes pregnant patients, those unable to provide consent within 12 hours of hospital admission, or individuals with contraindications to corticosteroids or ipratropium, patients who had used inhaled corticosteroids or muscarinic antagonists within the past 7 days, had ARDS onset prior to enrollment, or required mechanical ventilation before admission. Those with an expected hospital stay of less than 48 hours, poor prognosis, or admitted for palliative care will not be included in the trial. Participants will be randomized in a 1:1 ratio within 12 hours of presentation. This trial was approved by the BUC-Institutional Ethical Committee (No. BUC-IACUC-240318-80). All patients agree to participation will sign a participation consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined standard aerosolized doses of budesonide (0.5 mg/2 mL) and ipratropium bromide (500/2 mL) | Active comparator | 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 dayscombined 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 | Drug: Placeboplacebo (4 mL normal saline) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18 years or older)
Key exclusion criteria (10 listed)
- Pregnant patients
- History of asthma or chronic obstructive lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 dayscombined 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) and ipratropium bromide (500/2 mL) |
| PlaceboSaline inhaler | Drug | placebo (4 mL normal saline) |
Primary outcome
The primary outcome was longitudinal change in the S/F
Time frame: change in the S/F for up to 5 days
1 secondary outcome
progression to ARDS
Time frame: Through the ICU stay up to 28 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
amira B kassem principal investigator
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 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 in people with ARDS and Prevention and Control, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was longitudinal change in the S/F (time frame: change in the S/F for up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.