Effect of Antibiotic Therapy against Lophomonas blattarum in Asthmatic Subjects: A Phase 3 Clinical Trial.

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

Lophomnas blattarum was detected in a significant number of severe asthmatics, and treatment directed at this protozoan will cause a significant improvement in asthmatic subjects.