Abstract
Asthma is a chronic inflammatory airway disease. Increase in airway inflammation is hypothesised to contribute to worsening of asthma symptoms and deterioration in lung function, resulting in the use of reliever medication. Short-acting β2-agonists only treat the symptoms, whereas an anti-inflammatory reliever is believed to treat both symptoms and the underlying inflammation, thereby arresting the progression to an exacerbation. As-needed budesonide/formoterol as an anti-inflammatory reliever reduces the risk of severe exacerbations. However, supporting mechanistic evidence has not yet been described, specifically the temporal dynamics of parameters including airway inflammation, over time and during asthma worsening.
The STIFLE study aims to characterise daily variability in airway inflammation, symptoms, lung function and reliever use in people with asthma. This phase IV, open-label, parallel-group, multicentre, exploratory study will enrol 60–80 adult patients with asthma receiving low- or medium-dose inhaled corticosteroids/long-acting β2-agonists (EudraCT identifier number 2018-003467-64). Participants will be randomised 1:1 to either as-needed budesonide/formoterol dry-powder inhaler or salbutamol reliever for 24 weeks, in addition to their maintenance therapy. Daily data will be captured for fractional exhaled nitric oxide, spirometry, asthma symptoms and medication use using devices connected to a smartphone via the STIFLE application. STIFLE will thereby enable not only characterisation of the variability of airway inflammation and clinical outcomes in relation to asthma worsening, but also elucidate the effect of as-needed budesonide/formoterol on airway inflammation against a background of daily maintenance therapy.
Abstract
Using novel, home-based tools to generate new insights into the link between inflammation and asthma attacks, the STIFLE study aims to increase understanding of the mechanisms behind the benefits of budesonide/formoterol anti-inflammatory reliever therapy https://bit.ly/33X1wJU
Footnotes
This study is registered at https://eudract.ema.europa.eu/ with identifier number 2018-003467-64.
This article has supplementary material available from openres.ersjournals.com. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Conflict of interest: T. Harrison reports non-financial support from AstraZeneca for assistance with manuscript writing during the conduct of the study; grants, personal fees for advisory boards and speaker meetings, and support to attend conferences from AstraZeneca, fees for advisory boards and speaker meetings from GSK, and personal fees from Vectura, outside the submitted work.
Conflict of interest: I.D. Pavord reports speaker fees, advisory board honoraria, sponsorship to attend scientific meetings and payments for organising educational events from AstraZeneca; speaker fees, advisory board honoraria and sponsorship to attend scientific meetings from Boehringer Ingelheim; a speaker fee from Aerocrine; speaker fees and advisory board honoraria from Almirall and Novartis; speaker fees, advisory board honoraria and sponsorship to attend scientific meetings from GlaxoSmithKline; advisory board honoraria from Genentech and Regeneron; speaker honoraria, payments for organising educational events and sponsorship to attend scientific meetings from Teva; speaker honoraria from Chiesi; advisory board honoraria from Sanofi, Circassia and Knopp; and funding from NIHR as a Senior Investigator, all outside the submitted work.
Conflict of interest: J.D. Chalmers reports grants and personal fees from AstraZeneca during the conduct of the study; and grants and personal fees from GlaxoSmithKline, Boehringer Ingelheim, Zambon, Insmed, Grifols and Novartis, grants from Gilead, and personal fees from Napp, all outside the submitted work.
Conflict of interest: G. Whelan is an employee of AstraZeneca.
Conflict of interest: M. Fagerås is an employee of AstraZeneca.
Conflict of interest: A. Rutgersson is an employee of AstraZeneca.
Conflict of interest: L. Belton reports other from AstraZeneca, during the conduct of the study; other from AstraZeneca, outside the submitted work.
Conflict of interest: S. Siddiqui has nothing to disclose.
Conflict of interest: P. Gustafson is an AstraZeneca employee and shareholder.
Support statement: The STIFLE study is funded by AstraZeneca. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received November 28, 2019.
- Accepted March 24, 2020.
- Copyright ©ERS 2020
This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.