Evaluating the Use of Inhaled Budesonide and Ipratropium Bromide Combination in Patients at High Risk of Acute Respiratory Distress Syndrome Development: A Randomized Controlled Trial

DOI record: { "DOI": "10.3390/ph18030412", "ISSN": [ "1424-8247" ], "URL": "http://dx.doi.org/10.3390/ph18030412", "abstract": "<jats:p>Objectives: There is a scarcity of pharmacological treatments that efficiently address lung injury in individuals experiencing acute respiratory distress syndrome (ARDS). Early inhaled corticosteroids and ipratropium may reduce pulmonary inflammation and injury of the lungs, minimizing the risk of ARDS. Method: This is a double-blinded randomized control trial conducted on patients at risk of ARDS. Patients were randomly allocated into two groups; the intervention group (63 patients) were administered aerosolized budesonide and ipratropium bromide, and the control group (56) were administered a placebo every eight hours for five days. Alteration in oxygen saturation divided by inspired oxygen (Fio2) (S/F) after five days was the primary outcome. Secondary outcomes included ARDS occurrence, mechanical ventilation (MV) requirement, hospital stay duration, and mortality rates. Results: Of the 604 screened, only 119 patients were included. The intervention group (63 patients) S/F ratio recovered versus the fall of the control group. Both groups had similar organ dysfunction and 28-day mortality. The intervention group had significantly (p &lt; 0.001) fewer cases developing ARDS (9.5%) and MV (9.5%) than the control group (46.4% and 35.7%, respectively). Conclusions: The administration of inhaled budesonide and ipratropium bromide improved oxygenation, as assessed by the S/F ratio, and significantly reduced the rate of ARDS development and the requirement of MV versus the control group. Larger multi-center trials including diverse patient populations are needed to validate these results.</jats:p>", "alternative-id": [ "ph18030412" ], "author": [ { "ORCID": "https://orcid.org/0000-0003-4530-406X", "affiliation": [ { "name": "Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Badr University in Cairo, Cairo 11829, Egypt" } ], "authenticated-orcid": false, "family": "Moustafa", "given": "Hebatallah Ahmed Mohamed", "sequence": "first" }, { "affiliation": [ { "name": "Department of Clinical Pharmacy, Faculty of Pharmacy, Al Salam University, Kafr Alzayat 31611, Algharbia, Egypt" } ], "family": "Elbery", "given": "Faten H.", "sequence": "additional" }, { "affiliation": [ { "name": "College of Pharmacy, Al Ain University, Abu Dhabi P.O. Box 112612, United Arab Emirates" }, { "name": "AAU Health and Biomedical Research Center, Al Ain University, Abu Dhabi P.O. Box 112612, United Arab Emirate" } ], "family": "Al Meslamani", "given": "Ahmad Z.", "sequence": "additional" }, { "ORCID": "https://orcid.org/0009-0005-7322-7219", "affiliation": [ { "name": "Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Damanhour University, Damanhour 22514, Egypt" } ], "authenticated-orcid": false, "family": "Okda", "given": "Sherouk M.", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0001-6489-6035", "affiliation": [ { "name": "Department of Pharmaceutical Sciences, College of Pharmacy, Princess Nourah bint Abdulrahman University, P.O. Box 84428, Riyadh 11671, Saudi Arabia" } ], "authenticated-orcid": false, "family": "Alsfouk", "given": "Bshra A.", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0003-4195-6036", "affiliation": [ { "name": "Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Damanhour University, Damanhour 22514, Egypt" } ], "authenticated-orcid": false, "family": "Kassem", "given": "Amira B.", "sequence": "additional" } ], "container-title": "Pharmaceuticals", "container-title-short": "Pharmaceuticals", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2025, 3, 14 ] ], "date-time": "2025-03-14T17:07:51Z", "timestamp": 1741972071000 }, "deposited": { "date-parts": [ [ 2025, 3, 17 ] ], "date-time": "2025-03-17T12:05:59Z", "timestamp": 1742213159000 }, "funder": [ { "DOI": "10.13039/501100004242", "award": [ "PNURSP2025R142" ], "doi-asserted-by": "crossref", "id": [ { "asserted-by": "crossref", "id": "10.13039/501100004242", "id-type": "DOI" } ], "name": "Princess Nourah bint Abdulrahman University" } ], "indexed": { "date-parts": [ [ 2025, 3, 17 ] ], "date-time": "2025-03-17T12:40:28Z", "timestamp": 1742215228005, "version": "3.38.0" }, "is-referenced-by-count": 0, "issue": "3", "issued": { "date-parts": [ [ 2025, 3, 14 ] ] }, "journal-issue": { "issue": "3", "published-online": { "date-parts": [ [ 2025, 3 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 3, 14 ] ], "date-time": "2025-03-14T00:00:00Z", "timestamp": 1741910400000 } } ], "link": [ { "URL": "https://www.mdpi.com/1424-8247/18/3/412/pdf", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "1968", "original-title": [], "page": "412", "prefix": "10.3390", "published": { "date-parts": [ [ 2025, 3, 14 ] ] }, "published-online": { "date-parts": [ [ 2025, 3, 14 ] ] }, "publisher": "MDPI AG", "reference": [ { "DOI": "10.1001/jama.2016.0291", "article-title": "Epidemiology, Patterns of Care, and Mortality for Patients with Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries", "author": "Bellani", "doi-asserted-by": "crossref", "first-page": "788", "journal-title": "JAMA", "key": "ref_1", "volume": "315", "year": "2016" }, { "DOI": "10.1055/s-0033-1351121", "article-title": "Genetic Heterogeneity and Risk of Acute Respiratory Distress Syndrome", "author": "Meyer", "doi-asserted-by": "crossref", "first-page": "459", "journal-title": "Semin. 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