Bronchodilators and inhaled corticosteroids use in major global bronchiectasis registries
Editorial

Bronchodilators and inhaled corticosteroids use in major global bronchiectasis registries

Grace Oscullo1,2, Alberto García-Ortega3,4, Wei-Jie Guan5,6, Miguel Ángel Martinez-García1

1Pneumology Department, Research Institute La Fe University and Polytechnic Hospital, Valencia, Spain; 2Networked Biomedical Research Center for Respiratory Diseases, Carlos III Health Institute, Madrid, Spain; 3Respiratory Department, Doctor Peset University Hospital, Valencia, Spain; 4Foundation or the Promotion of Health and Biomedical in the Valencian Region (FISABIO), Valencia, Spain; 5Department of Allergy and Clinical Immunology, Department of Respiratory and Critical Care Medicine, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China; 6Guangzhou National Laboratory, Guangzhou, China

Correspondence to: Miguel Ángel Martinez-García, MD. Pneumology Department, Research Institute La Fe University and Polytechnic Hospital, Avinguda de Fernando Abril Martorell, 106, Quatre Carreres, 46026 Valencia, Spain. Email: mianmartinezgarcia@gmail.com.

Submitted May 13, 2025. Accepted for publication Jun 14, 2025. Published online Jul 08, 2025.

doi: 10.21037/jtd-2025-962

Undoubtedly, two of the most important clinical advances in the treatment of chronic inflammatory airway diseases have been the development of inhaled corticosteroids (ICSs) (1) and inhaled bronchodilators (BDs) (2) in patients with chronic obstructive pulmonary disease (COPD) (3) and asthma (4), and ICS especially in patients with asthma and (more recently) in COPD with eosinophilic endotype or the frequent exacerbator phenotype. The extensive use of BD and ICS in both asthma and COPD has been fueled by an abundance of international randomized clinical trials (RCTs) that have well proven their effectiveness, whether as monotherapy or in double or triple combination therapies (5).

Bronchiectasis is the third most common chronic inflammatory airway disease immediately following asthma and COPD globally (6,7). From a pathophysiological perspective, bronchiectasis is characterized by predominantly neutrophilic inflammation (8), sometimes with an increased in eosinophilic cells (9,10). During the natural history of progression, chronic bacterial infection (11) may aggravate airway inflammation, increase the symptom burdens, comorbidities (12,13), and worsen the prognosis (14,15). Functionally, the most common pattern is chronic airflow obstruction that is minimally reversible (16), with a progressive increase in dyspnea and the development of respiratory failure over time. A key aspect is that bronchiectasis is more common among both patients with severe COPD (30–50% of cases) (17) and severe asthma (20–25% of cases) (18) which have been associated with poorer clinical outcomes, partly because of the greater number and severity of exacerbations. It remains unknown whether COPD or asthma has a causal relationship with bronchiectasis (19) or if it is merely an association.

Regardless, the scientific evidence supporting the use of BD, ICS, or their various combinations in patients with bronchiectasis not associated with COPD or asthma is very limited. A thorough search on PubMed combining the terms “Bronchodilator”, “Long-acting”, “Short-acting”, “Salbutamol”, “Terbutaline”, “SABA”, “Salmeterol”, “Gormoterol”, “Levalbuterol”, Indacaterol”, “Olodoterol”, “Vilanterol”, “LABA”, “Ipratropium”, “Tiotopium”, “Aclidinium”, “Glicopyrronium”, “Umeclidinium”, “SAMA”, “Double therapy”, “Triple therapy”, and “Bronchiectasis” (all in the title) yielded only 11 records, of which only six were valid, and three of them were RCTs (20-22).

Of the three RCTs, the FORZA (20) study published in 2023 was a letter to the editor with 17 patients per arm (formoterol/beclometasone vs. placebo), which concluded that there was no improvement in the primary outcome (cough) with treatment, although the incidence of adverse effects was higher (probably due to ICS). The second RCT, published in 2012 (21), involved 40 patients and concluded that inhaled medium-dose formoterol-budesonide combination treatment was more effective and safer compared with the high-dose budesonide in patients with bronchiectasis. Finally, the third RCT, published in 2011 (22) with only nine patients, concluded that pre-medication with eformoterol protected patients with bronchiectasis from developing a significant reduction in forced expiratory volume in 1 second (FEV1) after inhaling mannitol.

Regarding ICS, the same exhaustive search was performed on PubMed with the terms including “Inhaled corticosteroids”, “Inhaled steroids”, “Nebulized corticosteroids”, “Nebulised steroids”, “Beclomethasone”, “Budesonide”, “Fluticasone”, “Mometasone”, “Ciclesonide”, “Double therapy”, and “triple therapy”, and “Bronchiectasis” all in the title. From the review of 39 documents, only six small RCTs were identified, yielding heterogeneous results (20,21,23-26). All of them employed high doses of ICS—specifically, two RCTs with beclomethasone (1,500 mcg/day), two with budesonide (800 mcg/day), and four with fluticasone (1,000 mcg/day). Overall, these studies reported generally positive outcomes for ICS compared to placebo, including reductions in sputum volume and improvements in morning peak expiratory flow rate, FEV1, cough, dyspnea, quality of life, use of rescue short-acting β-2 agonists, and decreases in sputum inflammatory markers (leukocyte density, eosinophils, interleukin (IL)-1β, IL-8, and leukotriene B4 (LTB4), with a more pronounced effect observed in patients with chronic bronchial infection due to Pseudomonas aeruginosa. However, these findings were of limited clinical relevance, and ICS use was associated with a general increase in adverse effects and minimal impact on pulmonary function or the frequency and severity of exacerbations. Two additional studies evaluated double therapy at medium doses. The first, comparing beclomethasone-formoterol to placebo (20), showed no clinical benefit but an increase in ICS-related adverse effects. The second, using budesonide-formoterol at medium doses (21), found that the addition of formoterol allowed for a 50% reduction in the budesonide dose without clinical deterioration, along with a significant reduction in ICS-related adverse effects.

Bronchiectasis patient registries constitute a vital source for the generation of real-world evidence. These multicenter datasets facilitate enhanced disease management by deepening our understanding of patient demographics, comorbidities, risk factors, and therapeutic approaches. Data from the largest bronchiectasis registries worldwide indicate that both BD (10.9–78.6%) and ICS (16.1–68.3%, excluding Asian registries) continue to be frequently prescribed (27). For example, in the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) registry, the use of ICS was nearly 50% (Table 1) (28).

Table 1

COPD and asthma etiologies in the largest available registries of bronchiectasis in the world

Etiology EMBARC (Europe) Historical (Spain) RIBRON (Spain) BRR (USA) IBR (India) ABR (Australia) KMBARC (S. Korea) China
Number 16,963 2,047 2,615 1,085 2,195 566 931 16,338
Period of inclusion 2015–on going 2002–2011 2015–on going 2008–on going 2015–2017 2016–on going 2018–on going 2020–on going
COPD and asthma etiology
   COPD 8.1% 7.7% 10.9% 20% 5.3% 3.4% 6.4% 4.9%
   Asthma 6.9% 5.4% 7.8% 29% 2.5% 3.7% 5% 1.5%
BD and ICS treatments
   BDs 78.6% 76.5% 78% 65%† 56.6% 63.8% 50.5% 10.9%
   ICSs 51.3% 68.1% 66.2% 50%† 63.2% 68.3% 16.1% 3.6%
Year 2023 2017 2023 2016 2019 2019 2025 2025
Patient’s available data 16,963 2,047 2,615 1,085 2,195 566 598 10,324

†, bronchiectasis not related to non-tuberculous mycobacteria infection. Number: total number of patients included in each registry. Period of inclusion: period of time in which the registry is open for the inclusion of patients. Year: year in which the data were collected by contact with the coordinator or from published data. Patient’s available data: number of patients with available data within the total number of patients included at the moment of publication. ABR, Australian Bronchiectasis Registry; BD, bronchodilator; BRR, Bronchiectasis Research Registry; COPD, chronic obstructive pulmonary disease; EMBARC, European Multicentre Bronchiectasis Audit and Research Collaboration; IBR, Indian Bronchiectasis Registry; ICS, inhaled corticosteroid; KEMBARC, Korean Multicentre Bronchiectasis Audit and Research Collaboration; RIBRON, Spanish Electronic Bronchiectasis Registry; S. Korea, South Korea.

What could be the reasons for this widespread use of BD and, especially, ICS without clear evidence of justifying their use in patients without COPD and asthma? Possibly, there is no single answer to this question. On one hand, there is likely a commercial aspect. Both COPD and asthma are two diseases with a longstanding historical evolution and prevalence in the general population (29,30), which has led pharmaceutical companies to invest heavily in large clinical trials demonstrating the efficacy of their drugs. Much effort has been invested by the major pharmaceutical companies to pursue further marketing globally. However, bronchiectasis which is deemed less common has not been considered as potentially profitable from a commercial standpoint (deemed as an airway infectious disease). This has prevented the development and evaluation of BD and ICS in bronchiectasis, and their effects have only been assessed more recently, entering the scientific attention in the early 21st century (31).

On the other hand, bronchiectasis has often been clinically considered as a condition similar to asthma and COPD, although its diagnosis requires a thoracic high-resolution computed tomography scan (only accessible at hospital level). Patients with bronchiectasis have been treated as if they had asthma or COPD with poor evolution. Additionally, it has probably been assumed that bronchiectasis shares, to a significant extent, the pathophysiology of COPD and asthma (32,33), leading to the intuition that BD and ICS would work similarly well in bronchiectasis. Finally, since the introduction of double and triple therapies combining ICS (34) with very simple administration (sometimes once daily), where patients who would only be treated with BD for dyspnea or cough might have ICS added in the same inhaler, under the assumption that they would not be deleterious, given that the neutrophilic inflammatory profile of COPD (35). COPD neutrophilia and bronchiectasis were presumed to be similar.

In a more detailed analysis that separates the overuse of BD and ICS, the fundamental problem lies in the overuse of ICS (27). With BD, the issue is usually less significant because, although scientific evidence in bronchiectasis is lacking, the longstanding experience with bronchiectasis patients treated with BD shows improvements in dyspnea, airflow obstruction, respiratory physiotherapy practices, or inhaled antibiotic use, with minimal adverse effects (despite the increased cardiovascular side effects associated with some of these drugs) (36).

However, the problem of ICS overuse deserves a separate reflection. ICS is not only a potent anti-inflammatory agent (especially in eosinophilic as opposed to neutrophilic inflammation), but also a common immunosuppressant. It is not surprising that in both COPD and bronchiectasis, studies have shown an increase in the frequency and severity of exacerbations (37,38). According to a study by Henkle et al. (39), the risk of death in bronchiectasis patients compared with those treated with macrolides approached statistical significance. More importantly, despite this knowledge, it seems that the situation has not been changed throughout the past two decades. For example, comparison of the two Spanish registries—one initiated in 2001 and completed in 2011 (a cross-sectional historical registry) with data from about 2,000 patients, and the current Spanish Electronic Bronchiectasis Registry (RIBRON), launched in 2015 and still ongoing with 2,615 patients and a median follow-up of 7 years—shows that the percentage of BD use (from 76.5% to 78%) and ICS use (from 68.1% to 66.2%) has not radically changed, although the diagnoses of asthma (from 5.4% to 7.8%) and COPD (from 7.7% to 10.9%) have increased. Despite this, the overuse of both drugs over time is evident. It is important to note that these data are only from Spain, the only country with two BE registries; therefore, the findings might not be directly extrapolated to other countries (40).

In summary, even with the limited existing scientific evidence and the clear contraindication established by both national and international guidelines (41-43)—except in special cases—both BD and, above all, ICS continue to be widely overused worldwide, despite their known adverse effects (some of which can be serious, especially in the case of ICS). It is surprising to consider how, in recent years, highly bronchiectasis-specific drugs have been developed—such as brensocatib (44), other dipeptidyl peptidase-1 inhibitors (e.g., HSK31858, SAVE-BE) (45), even biologic treatments (46)—that will undoubtedly represent a major advancement in personalized medicine for bronchiectasis. However, no RCTs with sufficient statistical power exist to conclusively demonstrate the effectiveness of BD and ICS, despite the fact that 60–70% of bronchiectasis patients continue to use them. Until this scientific evidence becomes available, it is absolutely necessary to raise awareness within the scientific community about the risks associated with their inappropriate prescription.

Acknowledgments

We thanks all the registry coordinators for providing us the current data of their bronchiectasis registries: T. Aksamit (USA), J. Chalmers (Scotland), F. Dhar (India), F. Ringshausen (Germany), S. Aliberti (Italy), L. Burr (Australia), Yeon-Mok Oh (South Korea), Jin-Fu Xu (China), T. Asakura (Japan), D. Kizilirmak (Turkey), A. de Soyza (UK), CA Wong (New Zeeland), P. Cururu (Argentina), C. Thornton (Canada), S. Rached (Brazil), and R. Caixada (Portugal).

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Journal of Thoracic Disease, for the series “Frontiers in bronchiectasis management: Translational science and practice”. The article did not undergo external peer review.

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-962/coif). The series “Frontiers in bronchiectasis management: Translational science and practice” was commissioned by the editorial office without any funding or sponsorship. W.J.G. served as an unpaid Guest Editor of the series and serves as an unpaid editorial board member of Journal of Thoracic Disease. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this article as: Oscullo G, García-Ortega A, Guan WJ, Martinez-García MÁ. Bronchodilators and inhaled corticosteroids use in major global bronchiectasis registries. J Thorac Dis 2025;17(7):5396-5401. doi: 10.21037/jtd-2025-962

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