Monthly pulmonology bulletin — September 28, 2026

Period covered: August 28 to September 28, 2026. The month was dominated by the ERS Congress 2026 (Barcelona, September 5–9), which concentrated the most relevant phase III results in COPD, pulmonary hypertension and pulmonary fibrosis; in tuberculosis and respiratory critical care no major randomized trials were published within the window, and we say so in each section. We include 16 items verified in the primary source or in reliable coverage with a confirmed date; the last one, in the cross-cutting section, covers artificial intelligence and regional health.

Asthma and COPD

1. Tozorakimab (anti-IL-33) reduces COPD exacerbations in two phase III trials (OBERON and TITANIA)

[Clinical trial] [ERS Congress 2026] [Multinational, AstraZeneca-sponsored]
Two twin double-blind, placebo-controlled trials randomized 2,306 patients with symptomatic COPD and at least two moderate or one severe exacerbation in the prior year, on maintenance inhaled therapy, to tozorakimab 300 mg subcutaneously every four weeks or placebo for 52 weeks. For the primary endpoint (annualized rate of moderate or severe exacerbations in former smokers) the reduction was 29% in OBERON (1.34 vs 1.90 per year; p = 0.002) and 34% in TITANIA (1.37 vs 2.07; p < 0.001); in the overall population, current smokers included, reductions were 30% and 29%. The effect was larger with high eosinophils (≥300: −43%) but persisted with eosinophils <150 (−23%). Presented as a late-breaker on September 8 and published simultaneously in NEJM.
Why it matters: it would be the first biologic effective in COPD regardless of eosinophilic phenotype and including current smokers; confidence intervals have not been released outside the paper, there was a small numerical imbalance in major cardiovascular events and deaths that warrants scrutiny, the drug is not approved anywhere (AstraZeneca plans an FDA filing in early 2027), and at biologic prices access in the Dominican Republic will be very limited.
https://www.astrazeneca.com/media-centre/press-releases/2026/tozorakimab-demonstrated-statistically-significant-highly-clinically-meaningful-reduction-copd-exacerbations-oberon-titania-phase-iii-trials.html
https://www.ajmc.com/view/tozorakimab-cuts-copd-exacerbations-up-to-34-in-phase-3-trials

2. European Commission approves Trixeo Aerosphere (budesonide/glycopyrronium/formoterol) for asthma from age 12

[Regulatory EMA] [European Union]
On September 23 AstraZeneca announced European approval of the single-inhaler pressurized triple therapy for asthma uncontrolled on medium-dose inhaled corticosteroid plus LABA, the first indication of its kind in the EU. The basis was the twin KALOS and LOGOS trials (about 4,300 patients randomized against budesonide/formoterol), with a significant improvement in trough FEV1 at 24 weeks and a reduction in the annualized rate of severe exacerbations in the pooled analysis, published in Lancet Respiratory Medicine in February 2026. The FDA had already approved the same combination (Breztri) in asthma.
Why it matters: it consolidates fixed triple therapy as a step before biologics, but the press release provides no absolute magnitudes or confidence intervals and the comparator was medium-, not high-dose ICS/LABA; in our setting, availability and price of the device will decide its real place.
https://www.astrazeneca.com/media-centre/press-releases/2026/trixeo-recommended-for-approval-in-the-eu-by-chmp-for-the-maintenance-treatment-of-asthma.html
https://news.europawire.eu/astrazenecas-trixeo-aerosphere-approved-in-the-european-union-as-first-triple-combination-maintenance-therapy-for-asthma-in-patients-aged-12-and-older/eu-press-release/2026/09/23/15/16/20/181156/

3. Semaglutide associated with fewer asthma and COPD exacerbations in a UK real-world cohort

[Observational publication] [ERS Congress 2026] [United Kingdom]
Imperial College London investigators compared new users of four GLP-1 agonists with sulfonylurea users in UK primary-care records (about 22,500 new semaglutide users), with propensity weighting that included BMI, smoking, eosinophils and disease severity. Only semaglutide was associated with fewer asthma attacks (up to 40% fewer according to the ERS release) and 20% fewer COPD exacerbations; liraglutide, dulaglutide and exenatide showed no significant association. Specialist coverage cites an overall weighted hazard ratio of 0.76 (95% CI 0.60–0.96).
Why it matters: a biologically plausible signal, but observational, restricted to diabetics, with likely residual confounding and no peer-reviewed publication; it does not justify prescribing semaglutide for the airway until randomized trials exist.
https://www.ersnet.org/news-and-features/news/weight-loss-injection-semaglutide-can-reduce-asthma-attacks-by-up-to-40-per-cent/
https://www.healio.com/news/allergy-asthma/20260914/semaglutide-associated-with-lower-exacerbation-risks-in-asthma-copd

4. COPERNICOS: eosinophil-guided inhaled corticosteroid withdrawal in severe COPD did not increase severe exacerbations, but non-inferiority was not shown

[Academic clinical trial] [ERS Congress 2026] [Denmark, multicenter]
Double-blind factorial trial (NCT04481555) in severe or very severe COPD comparing eosinophil-guided inhaled corticosteroid reduction with continued triple therapy, and azithromycin 250 mg three times weekly with placebo, with a primary endpoint of exacerbation with hospitalization or death at one year. As presented by Jørgen Vestbo, guided withdrawal did not significantly increase severe exacerbations or mortality, but the non-inferiority margin was not formally met; low-dose azithromycin also missed the primary endpoint.
Why it matters: it strengthens with randomized data the notion that eosinophil-guided de-escalation is reasonable, but the trial was underpowered (fewer exacerbations during the pandemic) and full figures (n, ratios, intervals) are not yet published, so the paper should be awaited.
https://www.ajmc.com/view/copernicos-trial-eosinophil-guided-ics-reduction-safe-in-copd-vestbo-says
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09032-0

Respiratory infections and tuberculosis

5. High-dose influenza vaccine in adults over 65 with chronic lung disease: fewer influenza or pneumonia hospitalizations (DANFLU-2 + GALFLU)

[Pragmatic clinical trial, pooled analysis] [ERS Congress 2026] [Denmark and Spain]
Prespecified pooled analysis of two pragmatic randomized trials of high-dose versus standard-dose vaccine (466,320 people randomized in total across five seasons, 2022–2025), focused on the subgroup of 31,976 participants with chronic lung disease (asthma, COPD, bronchiectasis, interstitial lung disease, among others). High dose reduced influenza or pneumonia hospitalizations by 8.8% and also cardiorespiratory and all-cause hospitalizations. Presented September 8 in Barcelona.
Why it matters: the best randomized evidence to date favoring high dose in older patients with lung disease, although it is a subgroup, the release gives no confidence intervals and the parent trials are Sanofi-sponsored; in the Dominican Republic the high-dose vaccine is not part of the public schedule, so the finding mainly informs individual prescribing.
https://www.ersnet.org/news-and-features/news/high-dose-flu-vaccine-beneficial-for-older-people-with-lung-disease/

6. JAMA publishes systematic reviews of RSV, influenza and COVID-19 vaccines for the 2026–2027 season

[Meta-analysis] [United States]
On September 2 JAMA published three systematic reviews from the Vaccine Integrity Project (CIDRAP). Against RSV (75 studies), effectiveness against hospitalization in adults 60 and older was 83.3% (95% CI 42.9–96.9) in the first season, falling from 81.1% at 0–6 months to 48.5% at 12–18 months; nirsevimab in infants reached 63.6% to 93%. Against influenza (69 studies), effectiveness against hospitalization in adults 65 and older ranged from 19% to 43%, with a relative effectiveness of high dose versus standard dose of 43.6% (95% CI 27.5–56.3); a self-controlled series of nearly 10 million vaccinees showed no excess of serious adverse events, including with coadministration. Against COVID-19 (155 studies), effectiveness against hospitalization in adults 65 and older was 53% in 2025–2026.
Why it matters: an independent synthesis useful for the pulmonology clinic in the middle of the season, limited by the heterogeneity of observational studies and scarce RSV durability data beyond 18 months.
https://jamanetwork.com/journals/jama/fullarticle/2853780
https://jamanetwork.com/journals/jama/fullarticle/2853779
https://jamanetwork.com/journals/jama/fullarticle/2853778

7. Cefepime and mortality: Bayesian meta-analysis of 110 trials

[Meta-analysis] [Canada]
Systematic review with Bayesian meta-analysis published in JAMA Network Open on September 10: 110 trials and 22,608 patients (11,726 on cefepime vs 10,882 on other beta-lactams), including severe infections and febrile neutropenia. The odds ratio for mortality was 1.10 (95% credible interval 0.98–1.24), with a 94.4% posterior probability of harm; in the 73 published trials the OR was 1.17 (1.02–1.34). The signal was concentrated in adults.
Why it matters: it reopens a 2007 FDA alert with broader data and a more appropriate method, although the effect is small, heterogeneity is high and 40 studies lacked bias assessment; for severe or nosocomial pneumonia, individualize and monitor for neurotoxicity, especially in renal failure.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2853883

8. FDA grants priority review to amikacin liposome inhalation suspension (Arikayce) as first-line therapy for Mycobacterium avium complex lung disease

[Regulatory FDA] [Industry] [United States]
On September 21 Insmed announced acceptance with priority review of its supplemental application, with a decision date of January 28, 2027. The basis is the phase 3b ENCORE trial: 425 treatment-naïve patients at 177 sites, randomized to inhaled liposomal amikacin plus azithromycin and ethambutol versus placebo plus the same regimen for 12 months. The primary endpoint (respiratory symptom score at month 13) was met and culture conversion was significantly higher; the most frequent adverse events were dysphonia (47% vs 1%), cough, bronchospasm and ototoxicity (17% vs 10%).
Why it matters: if approved, it would change the standard for initiating MAC lung disease treatment, but the company has not disclosed the effect size for the primary endpoint, toxicity is considerable and the drug's cost keeps it far from routine practice in Latin America.
https://www.hcplive.com/view/fda-grants-priority-review-insmed-arikayce-snda-mac-lung-disease

Tuberculosis note of the month: we identified no new trials or approvals dated within the window in Brazil, Peru, Mexico, India, China or the Dominican Republic. The Gamaleya Center (Russia) told the press on September 9 that it had completed phase 3 of a new tuberculosis vaccine, without publishing n, efficacy or registration; we record it only as an announcement pending data (source in Russian: https://iz.ru/2163627/2026-09-09/v-tcentre-gamalei-zavershili-klinicheskie-issledovaniia-novoi-vaktciny-ot-tuberkuleza).

Interstitial lung disease, pulmonary hypertension and sleep

9. FDA updates the sotatercept (Winrevair) label with HYPERION data in recently diagnosed pulmonary arterial hypertension

[Regulatory FDA] [Clinical trial] [United States, Merck-sponsored]
On September 22 Merck announced that the FDA added HYPERION results to the label: 320 adults with PAH diagnosed within the prior 12 months, functional class II–III and intermediate or high risk, randomized to sotatercept or placebo on background therapy. Time to first clinical worsening event improved with a hazard ratio of 0.24 (95% CI 0.14–0.41; p < 0.0001), with events in 10.6% vs 36.9%. The most frequent adverse events were epistaxis (31.9% vs 6.9%), telangiectasia and increased hemoglobin.
Why it matters: it supports early use after diagnosis rather than only as rescue, although the trial was stopped early for efficacy (which tends to overestimate the effect) and access in Latin America remains exceptional because of price.
https://www.merck.com/news/u-s-fda-approves-update-to-the-label-for-winrevair-sotatercept-csrk-to-include-data-from-the-phase-3-hyperion-trial-evaluating-adults-recently-diagnosed-with-pulmonary-arterial-hypertensio/

10. Ralinepag reduces clinical worsening in PAH: ADVANCE OUTCOMES presented at ERS 2026

[Clinical trial] [ERS Congress 2026] [Multinational, United Therapeutics-sponsored]
Event-driven, double-blind phase III trial of 687 patients (350 oral ralinepag, 337 placebo) on background therapy, 80% already on dual therapy. Time to first adjudicated clinical worsening showed a hazard ratio of 0.45 (95% CI 0.33–0.62; p < 0.001); at week 28 NT-proBNP fell 24.3% versus placebo and six-minute walk distance improved by 20.4 meters. Adverse events were those typical of prostacyclins (headache, diarrhea, nausea, myalgia). The FDA accepted the new drug application on August 24.
Why it matters: a once-daily oral IP agonist with an effect on hard outcomes would be a practical alternative to selexipag, but the analysis presented is the company's and has not yet been published with peer review.
https://ir.unither.com/press-releases/2026/08-28-2026-120018204
https://www.hcplive.com/view/ralinepag-improves-clinical-outcomes-in-contemporary-pah-population

11. FDA accepts the application for inhaled treprostinil (Tyvaso) in idiopathic pulmonary fibrosis based on TETON-1 and TETON-2

[Regulatory FDA, application acceptance] [United States, United Therapeutics-sponsored]
On September 2 United Therapeutics reported acceptance of the supplemental application, with a decision expected in late April 2027. In the pooled analysis of the two 52-week placebo-controlled phase III trials, the difference in change in forced vital capacity was 111.8 mL (95% CI 79.7–144.0; p < 0.0001), with favorable secondary endpoints in clinical worsening, acute exacerbation and DLCO. Additional data were presented at ERS 2026.
Why it matters: it would be the first inhaled antifibrotic and the third drug approved for IPF in a decade, but the primary endpoint is functional (surrogate), the figures come from the company's release and the nebulized device dosed four times daily limits adherence.
https://ir.unither.com/press-releases/2026/09-02-2026-120033661

Note: at ERS 2026 interim safety data from the FIBRONEER-ON open-label extension of nerandomilast were presented (1,643 patients with IPF or progressive pulmonary fibrosis; discontinuation for adverse events 6.9% in continuers and 10.2% in new starters; diarrhea 24.8% vs 16%), an open-label analysis without comparator sponsored by Boehringer Ingelheim: https://www.hcplive.com/view/fibroneer-on-nerandomilast-durable-ipf-ppf-safety-wuyts

12. Obstructive sleep apnea: FDA accepts the application for AD109 (aroxybutynin + atomoxetine), the first oral drug targeting upper-airway collapse

[Regulatory FDA, application acceptance] [Industry] [United States]
Apnimed announced on September 8 acceptance of the application, with a decision date of February 28, 2027. The program rests on the phase III SynAIRgy trial (646 patients; apnea-hypopnea index reduction of 4.0 events per hour versus placebo, 95% CI −6.4 to −1.6, p = 0.001; geometric reduction 44.1% vs 17.6%) and LunAIRo, presented at ATS and SLEEP 2026 and published in AJRCCM in May.
Why it matters: a nightly pill would interest the huge population that does not tolerate CPAP, but the absolute reduction in the index is modest, about 21% discontinued for adverse events and there are no cardiovascular outcome data; this is a regulatory step, not yet a change in practice.
https://ir.apnimed.com/news-releases/news-release-details/apnimed-reports-second-quarter-2026-financial-results-and

Lung cancer, interventional pulmonology and respiratory critical care

13. BRELT3: mobile low-dose CT lung cancer screening for a vulnerable population in Bahia, Brazil

[WCLC 2026 Congress] [Brazil]
Prospective single-arm study presented September 15 at the World Conference on Lung Cancer (Seoul): of 5,223 candidates, 2,018 current or former smokers aged 50–80 were screened in a mobile unit (87% non-white, 64% with only primary education, 59% current smokers). There were 283 Lung-RADS 3–4 results and 19 cancers were diagnosed (detection rate 0.94%), seven at advanced stage and seven resected; community health workers recruited 44% of participants and about 60% of rural participants.
Why it matters: the Latin American item of the month, showing that screening is feasible outside large hospitals with a detection rate similar to the classic trials; without a comparator, with 12 indicated biopsies not performed and no mortality data, it serves as an implementation model (highly pertinent for the Caribbean) rather than proof of benefit.
https://www.eurekalert.org/news-releases/1142926
https://ascopost.com/news/september-2026/mobile-ct-lung-cancer-screening-may-expand-access-for-underserved-populations/

14. SPRAY-CB: bronchoscopic liquid-nitrogen metered cryospray versus sham in chronic bronchitis

[Clinical trial] [AJRCCM publication] [United States and United Kingdom, industry-sponsored]
Sham-controlled 2:1 randomized trial at more than 15 sites: 203 patients with COPD and chronic bronchitis (136 cryospray, 67 sham), with two bronchoscopies 30–60 days apart. At 12 months the difference in total SGRQ was −5.9 points (95% CI −11.6 to −0.2; p = 0.042) and in CAT −3.4 (−5.8 to −1.0; p = 0.005); pneumothorax occurred in 3.6% of procedures and there were eight deaths (six vs two), none attributed to the device. Published online September 21.
Why it matters: the first sham-controlled trial of this technique, but the effect is borderline significant and its interval includes values below the SGRQ minimal important difference; the imbalance in deaths and the manufacturer's sponsorship call for more data before considering it in practice.
https://academic.oup.com/ajrccm/advance-article/doi/10.1093/ajrccm/aamag502/8826336

15. Phenotypes of weaning failure from mechanical ventilation: WEAN SAFE analysis of 5,664 patients

[Observational publication] [International, 50 countries]
Secondary analysis of the prospective WEAN SAFE cohort published in Intensive Care Medicine on September 9: 664 patients (15.1%) met criteria for weaning failure, with ICU mortality of 78% versus 2% among those successfully weaned. Three phenotypes are described: a single separation attempt followed by limitation of life-sustaining treatment, a single attempt without limitation, and multiple attempts; failure of the first attempt was strongly associated with the decision to limit support and with death.
Why it matters: it identifies the first separation attempt as a critical decision point, useful for weaning protocols in our ICUs, although it is observational, with post hoc phenotypes and no causal inference.
https://link.springer.com/article/10.1007/s00134-026-08592-2

Critical care note of the month: no randomized trials of ARDS, ventilation or oxygen therapy in adults were published in NEJM, Lancet or JAMA within the window. In South Korea, the open-label EVER trial (Intensive Care Medicine, August 26; 169 patients ventilated for sepsis or respiratory failure) found no benefit of a stepwise early mobilization program on physical function at discharge (FSS-ICU 23.6 vs 22.2; p = 0.44): https://link.springer.com/article/10.1007/s00134-026-08598-w

Cross-cutting

16. Artificial intelligence: China starts the first phase III trial of a generative-AI-designed drug for IPF (rentosertib, GENESIS-IPF-3)

[Clinical trial, initiation] [Industry] [China]
Insilico Medicine announced on September 9 the first dose in GENESIS-IPF-3 (NCT07687459): a 52-week randomized, double-blind, placebo-controlled trial with 320 planned patients at 47 Chinese sites and annual rate of FVC decline as the primary endpoint. Rentosertib, a TNIK inhibitor whose target and molecule were identified with generative AI, had shown a signal in a 12-week phase IIa published in Nature Medicine in 2025.
Why it matters: a methodological rather than clinical milestone, with no results yet, in a single country and with a sponsor-designed protocol; whether findings replicate outside China remains to be seen (source in English; trial also registered in the Chinese registry CTR20262475).
https://www.prnewswire.com/news-releases/insilico-medicine-doses-first-patient-in-genesis-ipf-3-the-worlds-first-phase-iii-trial-of-a-generative-ai-driven-innovative-drug-302873749.html

Regional health: PAHO reported on September 25 that Trinidad and Tobago began sentinel surveillance of severe acute respiratory infection (influenza, RSV and SARS-CoV-2) in two hospitals under the WHO Mosaic framework; an implementation note without clinical data, but relevant for Caribbean surveillance: https://www.paho.org/en/news/25-9-2026-framework-field-trinidad-and-tobago-begins-implementing-sari-sentinel-surveillance

Guidelines and regulation: no new GOLD, GINA, ATS, ERS, SEPAR or ALAT guidelines were published within the window (the GOLD report usually appears in November). At the September 14–17 CHMP meeting the only respiratory item was a positive opinion for Adcomfo, an omalizumab biosimilar. We identified no PMDA, NMPA, ANVISA, COFEPRIS or DIGEMAPS pulmonology approvals with a verifiable date in the period.

Upcoming meetings and dates

• October 13–17, 2026: 42nd Brazilian Congress of Pulmonology and Phthisiology (SBPT), Natal, Brazil. https://sbpt.org.br/sbpt2026/
• October 18–21, 2026: CHEST 2026, Phoenix, Arizona (pre-congress courses October 17). https://www.chestnet.org/Learning-and-Events/Events/CHEST-Annual-Meeting
• Next ALAT congress: July 7–10, 2027, San José, Costa Rica. https://www.congreso2027alat.com/
• Regulatory dates: Arikayce in MAC (January 28, 2027), AD109 in sleep apnea (February 28, 2027), Tyvaso in IPF (late April 2027).

Monthly pulmonology bulletin — September 28, 2026
16 verified items from the past month: NEJM, JAMA, JAMA Network Open, AJRCCM, Intensive Care Medicine, ERS Congress 2026, WCLC 2026 and FDA/EMA decisions.
Three worth your time:
• Tozorakimab (anti-IL-33) cut COPD exacerbations by 29% and 34% versus placebo in OBERON and TITANIA (2,306 patients), including low-eosinophil patients and current smokers; manufacturer-sponsored and not yet approved.
• High-dose influenza vaccine in adults over 65 with chronic lung disease (31,976 participants in DANFLU-2 and GALFLU): 8.8% fewer influenza or pneumonia hospitalizations; a subgroup analysis with no published confidence intervals.
• Sotatercept in recently diagnosed PAH (HYPERION, 320 patients): hazard ratio 0.24 for clinical worsening, now on the FDA label; trial stopped early for efficacy.
Full bulletin, with a critical reading of each study and links to primary sources:
https://boletinesmedicos.com/en/neumologia/2026-09-28.html
#Pulmonology #COPD #PulmonaryHypertension #Vaccines #ERS2026

Pulmonology, September 2026: tozorakimab cut COPD exacerbations 29–34% vs placebo (OBERON/TITANIA, n=2,306); high-dose flu vaccine in lung patients over 65: −8.8% hospitalizations. Critical reading and sources: https://boletinesmedicos.com/en/neumologia/2026-09-28.html