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fb artDansk Lungemedicinsk Selskab har mere end 10 stående udvalg indenfor f.eks. telemedicin, retningslinjer m.m. og deltager med repræsentanter i forskellige udvalg under Sundhedsstyrelsen. Foreningen af Yngre Lungemedicinere, som repræsenterer næste generation af lungemedicinske speciallæge, er organiseret under Dansk Lungemedicinsk Selskab.

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Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level

Professor: Peter Lange 

Artikel link | DOI | PubMed | Journal: N Engl J Med.I Dato: 2019 Maj

Kommentar til artiklen:

Det er et interessant studie, hvor fokus er på de daglige symptomer og lungefunktionen, mens risikoen for astmaeksacerbationer ikke er belyst på grund af studiets korte varighed. Resultaterne stemmer godt overens med de kliniske erfaringer, som viser, at langtfra alle patienter med astma har en tilfredsstillende effekt af ICS. Studiet viser, at respons på ICS til en vis grad kan forudsiges på baggrund af typen af luftvejsinflammation. Især patienter med høj grad af ”type 2 inflammation”, hvor de eosinofile celler spiller en fremtrædende rolle, har god respons på ICS. Studiet åbner op for, at andre inhalerede medikamenter, i dette tilfælde TIO, kan være et bedre valg til patienter med astma uden ”type 2 inflammation”. Det bliver spændende at se, om resultaterne kan blive reproduceret i studier af længere varighed, som også ser på risikoen for eksacerbationer. Det er det, som skal til, før de nuværende kliniske guidelines, som anbefaler ICS som førstevalg til alle med persisterende astma, bliver ændret

Abstract

BACKGROUND
In many patients with mild, persistent asthma, the percentage of eosinophils in sputum is
less than 2% (low eosinophil level). The appropriate treatment for these patients is unknown.
METHODS
In this 42-week, double-blind, crossover trial, we assigned 295 patients who were at least
12 years of age and who had mild, persistent asthma to receive mometasone (an inhaled
glucocorticoid), tiotropium (a long-acting muscarinic antagonist), or placebo. The patients
were categorized according to the sputum eosinophil level (<2% or ≥2%). The primary
outcome was the response to mometasone as compared with placebo and to tiotropium
as compared with placebo among patients with a low sputum eosinophil level who had
a prespecified differential response to one of the trial agents. The response was determined
according to a hierarchical composite outcome that incorporated treatment failure,
asthma control days, and the forced expiratory volume in 1 second; a two-sided P value
of less than 0.025 denoted statistical significance. A secondary outcome was a comparison
of results in patients with a high sputum eosinophil level and those with a low level.
RESULTS
A total of 73% of the patients had a low eosinophil level; of these patients, 59% had a
differential response to a trial agent. However, there was no significant difference in the
response to mometasone or tiotropium, as compared with placebo. Among the patients
with a low eosinophil level who had a differential treatment response, 57% (95% confidence
interval [CI], 48 to 66) had a better response to mometasone, and 43% (95% CI,
34 to 52) had a better response to placebo (P = 0.14). In contrast 60% (95% CI, 51 to 68)
had a better response to tiotropium, whereas 40% (95% CI, 32 to 49) had a better response
to placebo (P = 0.029). Among patients with a high eosinophil level, the response
to mometasone was significantly better than the response to placebo (74% vs. 26%) but
the response to tiotropium was not (57% vs. 43%).
CONCLUSIONS
The majority of patients with mild, persistent asthma had a low sputum eosinophil level
and had no significant difference in their response to either mometasone or tiotropium
as compared with placebo. These data provide equipoise for a clinically directive trial to
compare an inhaled glucocorticoid with other treatments in patients with a low eosinophil
level. (Funded by the National Heart, Lung, and Blood Institute; SIENA ClinicalTrials
.gov number, NCT02066298.)