National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran TANAFFOS (Respiration) 1735-0344 24 2 2025 04 01 Effect of Antibiotic Therapy against Lophomonas blattarum in Asthmatic Subjects: A Phase 3 Clinical Trial 181 186 734850 EN Younos Ghaderi Department of Cardiology, Imam Reza hospital, Mashhad University of medical sciences, Mashhad, Iran 0000-0002-6475-7120 Majid Mirsadraee Department of Internal Medicine, Islamic Azad University- Mashhad Medical Sciences Branch, Mashhad, Iran 0000-0003-3420-9438 Fariba Berenji Department of Medical Parasitology, Imam Reza Hospital, Central Lab, Parasitology & Mycology Lab, Mashhad University of Medical Sciences, Mashhad, Iran 0000-0002-8412-8858 Zahra Naseri Anhaei Department of Gynecology and Obstetrics, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran 0000-0001-6353-3857 Shadi Ghafari Department of Physiology, Faculty of Biology, Islamic Azad University-Damghan Branch, Damghan, Iran 0000-0002-9176-8650 Journal Article 2023 10 03 Background: Lophomonas blattarum causes chronic non-specific respiratory symptoms, which can easily mask asthma symptoms. The study aimed to predict the benefits of eradicating Lophomonas on the course of asthma. Materials and Methods: Fifty subjects resistant to high-dose inhaled corticosteroid/long-acting beta 2 agonist and other controllers such as montelukast or tiotropium were enrolled in this phase 3 clinical trial. Lophomonas was evaluated using a direct wet smear of bronchial lavage or induced sputum. Random allocation was performed by drawing lots from identical envelopes, and concealment was achieved by repackaging Tinidazole and placebo (vitamin B1) tablets in identical bottles. The clinic staff were blind to the study, and the code was opened by a pharmacist. The primary outcome was the asthma control test (ACT) score. Results: Direct smear showed Lophomonas in 52% of the Tinidazole group and 28% of the control group. Other baseline parameters were not significantly different between the Tinidazole and control groups. Cough disappeared in 12 out of 25 (48%) in the Tinidazole group (P=0.001), and the scoring of cough and dyspnea showed significant improvement in the Tinidazole group. Post-nasal drip, sputum, wheezing, and airway hyper-responsiveness were other secondary parameters that showed significant improvement. The ACT score improved from 16.84±2.65 at baseline to 23.11±2.58, and FENO and FEV1 were other objective outcomes that showed significant improvement. Conclusion: <span lang="EN-US" style="font-size: 9.0pt; font-family: 'Book Antiqua','serif'; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: major-bidi; color: black; mso-themecolor: text1; mso-font-width: 105%;">Lophomnas blattarum<span lang="EN-US" style="font-size: 9.0pt; font-family: 'Book Antiqua','serif'; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: major-bidi; color: black; mso-themecolor: text1; mso-font-width: 105%;"> was detected in a significant number of severe asthmatics, and treatment directed at this protozoan will cause a significant improvement in asthmatic subjects.

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