Peter G Gibson’s research while affiliated with Newcastle University and other places

Objectives The Breathing for Life Trial (BLT) was a multicentre randomised controlled trial testing the hypothesis that a fractional exhaled nitric oxide-based intervention to guide asthma therapy in pregnancy improves perinatal outcomes. While BLT was negative based on selected outcomes, the conduct of the trial over 7 years showed potential for assessing the broader research impacts and returns on investment in BLT. The aim of this study was to retrospectively assess and report on the impact and value of BLT to show accountability for the research investment in what was deemed a ‘negative’ trial. Methods The Framework to Assess the Impact from Translational health research (FAIT) was selected as the preferred method. FAIT combines three validated methods, including a modified Payback framework, an economic analysis of return on investment and a narrative account of the impact generated from the research. Data collection was done via document analysis of BLT administrative and research records and review of relevant websites/databases. Results BLT delivered a return on investment of $6.7 million in leveraged grants, fellowships and consultancies and conservatively returned$2.44 for every dollar invested. The research trained and upskilled 18 midwives and obstetricians in evidence-based asthma management in pregnancy and improved research capability of six PhD students. Specialised equipment purchased by BLT is now being repurposed to undertake other research in regional Australia, saving further research investment. Of the 1200 mothers who were part of BLT, 508 now have written asthma plans, 268 had a clinically significant improvement in their asthma control score and the proportion who improved their asthma plan knowledge increased by 58 percentage points from 12 to 70%. Conclusion This case example in the developing field of impact assessment illustrates how researchers can use evidence to demonstrate and report more broadly on the impact of and returns on research investment in a clinical trial. Trial registration number ACTRN12613000202763; Post results.

Background and Objectives Treatable trait‐based personalised medicine improves outcomes in severe asthma clinics. We assessed the feasibility of a randomised controlled trial (RCT) of protocolised treatable trait‐guided asthma management in patients not under a severe asthma clinic. Methods Ten week single‐group cohort study. Participants had a doctor's diagnosis of asthma, Asthma Control Questionnaire‐5 (ACQ‐5) score > 1, and ≥ 1 exacerbation in the last year. Intervention: biomarker‐guided asthma medication according to a protocolised algorithm, targeting traits of type‐2 inflammation and airflow obstruction. Feasibility outcomes: recruitment rates, acceptability of intervention, willingness to enrol in an RCT, need for ‘extended’ trait assessment after 10 weeks, and estimation of trait prevalence. Results Recruitment ceased with 29/50 participants after 14 months due to difficulties associated with COVID‐19. Recruitment rate: 29/118 (25%) of those invited to participate (95% CI 17 to 33). 24/26 (92%) participants found the intervention acceptable and were willing to participate in a future study. After 10 weeks, 65% remained not well controlled (ACQ‐5 > 1) and would have required the ‘extended’ assessment. Participants had a mean (SD) 4.8 (2.3) of 13 traits assessed. ACQ‐5 improved during the study by −1.0 (0.3 to 1.8) units, and post‐bronchodilator airflow limitation reduced from 59% of participants to 35%. 12/29 (41%) participants received continuous oral corticosteroids at some point during the study. Conclusion Protocolised treatable trait management was acceptable to participants, associated with significant clinical benefit, and a full RCT appears feasible. Targeting type‐2 inflammation and airflow obstruction was insufficient to control asthma in the majority of patients, despite marked systemic corticosteroid exposure. Trial Registration: ACTRN12620000935932

Background Improved maternal asthma management in pregnancy may reduce recurrent bronchiolitis and wheeze outcomes in infancy. Objective: We assessed whether infant bronchiolitis and wheeze outcomes are influenced by inflammation-guided management intervention, inhaled corticosteroid (ICS) use or exacerbations in pregnancy. Methods Randomized controlled trial (RCT) secondary analysis and observational cohort analysis using the same study population. Between 2013–2023, pregnant women (12–23 weeks gestation) from 6 centers in Australia were recruited and randomized to inflammation-guided asthma management or usual care. ICS use and asthma exacerbations were reported during pregnancy and postnatally. When infants were 6 (n=691) and 12 (n=606) months of age respiratory information was collected from parents and medical records. Associations for the RCT and observational analyses were assessed with logistic regression. Results Guided asthma management in pregnancy was not associated with bronchiolitis or wheeze-related outcomes, for example, recurrent bronchiolitis at 12 months: intervention OR 1.04 (95%CI 0.62, 1.73). In the observational analyses, ICS use in pregnancy was not associated with respiratory outcomes, however, asthma exacerbations in pregnancy were associated with ≥1 bronchiolitis episode (adjOR 2.20 95%CI 1.28, 3.76) or croup episode (adjOR 4.34, 95%CI 1.89, 9.96) at 6 months, and wheeze (adjOR 1.80, 95%CI 1.14, 2.84) and increasing wheeze episodes at 12 months (adjOR 1.81, 95%CI 1.17, 2.79). Conclusion Although there was no evidence that guided asthma management or ICS use in pregnancy reduces infant bronchiolitis or wheeze, maternal asthma exacerbations are an important risk factor for these outcomes. Further research is needed to reduce exacerbations in pregnancy.

The International Severe Asthma Registry (ISAR) was established in 2017 to advance the understanding of severe asthma and its management, thereby improving patient care worldwide. As the first global registry for adults with severe asthma, ISAR enabled individual registries to standardize and pool their data, creating a comprehensive, harmonized dataset with sufficient statistical power to address key research questions and knowledge gaps. Today, ISAR is the largest repository of real-world data on severe asthma, curating data on nearly 35,000 patients from 28 countries worldwide, and has become a leading contributor to severe asthma research. Research using ISAR data has provided valuable insights on the characteristics of severe asthma, its burdens and risk factors, real-world treatment effectiveness, and barriers to specialist care, which are collectively informing improved asthma management. Besides changing clinical thinking via research, ISAR aims to advance real-world practice through initiatives that improve registry data quality and severe asthma care. In 2024, ISAR refined essential research variables to enhance data quality and launched a web-based data acquisition and reporting system (QISAR), which integrates data collection with clinical consultations and enables longitudinal data tracking at patient, center, and population levels. Quality improvement priorities include collecting standardized data during consultations and tracking and optimizing patient journeys via QISAR and integrating primary/secondary care pathways to expedite specialist severe asthma management and facilitate clinical trial recruitment. ISAR envisions a future in which timely specialist referral and initiation of biologic therapy can obviate long-term systemic corticosteroid use and enable more patients to achieve remission.