The Azithromycin to Prevent Wheezing following severe RSV bronchiolitis-II clinical trial: Rationale, study design, methods, and characteristics of study population

Severe respiratory syncytial virus (RSV) bronchiolitis in early life is a significant risk factor for future recurrent wheeze (RW) and asthma. The goal of the Azithromycin to Prevent Wheezing following severe RSV bronchiolitis II (APW-RSV II) clinical trial is to evaluate if azithromycin treatment in infants hospitalized with RSV bronchiolitis reduces the occurrence of RW during the preschool years. The APW-RSV II clinical trial is a double-blind, placebo-controlled, parallel-group, randomized trial, including otherwise healthy participants, ages 30 days-18 months, who are hospitalized due to RSV bronchiolitis. The study includes an active randomized treatment phase with azithromycin or placebo for 2 weeks, and an observational phase of 18-48 months. Two hundred participants were enrolled during three consecutive RSV seasons beginning in the fall of 2016 and were randomized to receive oral azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for an additional 7 days, or matched placebo. The study hypothesis is that in infants hospitalized with RSV bronchiolitis, the addition of azithromycin therapy to routine bronchiolitis care would reduce the likelihood of developing post-RSV recurrent wheeze (≥3 episodes). The primary clinical outcome is the occurrence of a third episode of wheezing, which is evaluated every other month by phone questionnaires and during yearly in-person visits. A secondary objective of the APW-RSV II clinical trial is to examine how azithromycin therapy changes the upper airway microbiome composition, and to determine if these changes are related to the occurrence of post-RSV RW. Microbiome composition is characterized in nasal wash samples obtained before and after the study treatments. This clinical trial may identify the first effective intervention applied during severe RSV bronchiolitis to reduce the risk of post-RSV RW and ultimately asthma

The impact of a school-based, nurse-delivered asthma health education programme on quality of life, knowledge and attitudes of Saudi children with asthma

Background More than two million people have asthma in Saudi Arabia: 13% aged 6-10 years. Asthma is one of the most common childhood illnesses. Little has been explored about children’s ability to learn more about their own asthma in Saudi Arabia. Aims The study was designed to assess the impact of a school-based, nurse-delivered asthma health education programme on asthmatic children's knowledge and attitude towards asthma, quality of life, anxiety level, and school absenteeism. Methods A quasi-experimental, non-equivalent groups, pre-test post-test design was used. The education programme was developed from existing evidence. The Paediatric Asthma Quality of Life Questionnaire, Spence Anxiety Tool, Asthma Knowledge Questionnaire, and Asthma Attitude Questionnaire were employed for data collection. Intervention (n=130) and control (n=98) groups were drawn from 10 schools in Ha’il region, Saudi Arabia. Descriptive and inferential statistics were used to examine differences within and between groups. Results Knowledge of asthma increased significantly more in the intervention group than in the control group. Attitude toward asthma was not changed by the intervention. Anxiety scores reverted to pre-test level by post-test II. The intervention group had significantly better total quality of life scores than the control group, and school absenteeism reduced significantly after delivery of the programme. Conclusion The asthma education programme impacted positively on students' knowledge, quality of life, and school attendance. However, asthma education did not change attitudes towards the condition, and the impact on anxiety was not persistent. The results emphasise the benefits of provision of health education directly to children. Asthma education should be integrated into the Saudi national child health programme. Key words: Asthma, Children, Education programme, Self-agenc