Antibiotic Therapy in Asthma as One of First Step Treatment, a Phase 3 Randomized Clinical Trial

Sara Nejati; Majid Mirsadraee; Shadi Ghaffari

doi:10.18502/jmb.v12i3.16609

Sara Nejati Department of Health, Mashhad University of Medical Sciences, Mashhad, Iran.
Majid Mirsadraee Islamic Azad University-Mashhad Medical Sciences Branch, Mashhad, Iran
Shadi Ghaffari Department of Physiology, Faculty of Biology, Islamic Azad University-Damghan Branch, Damghan, Iran.

DOI: https://doi.org/10.18502/jmb.v12i3.16609

Keywords: Antibiotic therapy, Asthma, Bacterial translocation, Doxycycline, Pseudoasthma.

Abstract

Background: Focus of this study was on subjects suffering from new onset asthma, but actually, they may involve with an infection. Objectives: The target of this study was to determine the frequency of total control of asthma in new onset asthma.

Methods: this is a phase 3 randomized clinical trial. The participants were 50 new onset asthma, who feel suffering from respiratory infection, however the physician diagnosis was asthma according to wheezy chest, spirometry and clear chest roentgenogram. Age less than 18 years and pregnant women were excluded. The subjects were randomly divided into two groups, doxycycline hyclate and the placebo arms. The drugs were repacked in similar in shape container. Primary endpoint was time to first recurrence. Secondary endpoints were frequency of total control of asthma, dyspnea, cough, asthma control test (ACT) score, FEV1, FEV1/FVC, eosinophil and neutrophil in blood and sputum.

Results: The difference of clinical findings between two groups before the trial were not significant. Ten percent reported acute attack of asthma during last two months. Treatment with Doxycyline revealed significant improvement of clinical findings, asthma attack and ACT score after two months of treatment, however, complete resolution of clinical findings were significantly higher in Doxycyline group compare to placebo. Clinical findings and FEV1 percent predicted in Doxycyline group T2low asthma group showed significant improvement which were not depicted in T2high group. Eighteen months follow up of the subjects showed complete resolution of asthma symptoms in 12 (48%) on Doxycyline group, which was significantly higher than control group (5 (20%). Time to first exacerbation in doxycycline group was 13.6±5.64 months which was significantly longer than control group (7.49±6.95, P=0.002). Time to first exacerbation in CRP positive was significantly longer (13.64±5.35 months) than CRP negative subjects (9.67±7.76 months, P=0.02).

Conclusion: Doxycycline is an effective antibiotic for preventing recurrence of asthma, in selected new subjects who suspicious for respiratory infection.