BARCELONA — Patients with heavy mucus secretions they couldn’t readily expectorate obtained some relief with IV N-acetylcysteine (NAC), a researcher said here.
After seven days of treatment in a randomized trial conducted in China, mean sputum viscosity scores declined by 0.24 points more with NAC than placebo injections (P<0.001), and scores for expectoration difficulty also decreased more with NAC by 0.29 points (P=0.002), in accordance with Alberto Papi, MD, of the University of Ferrara in Italy.
NAC also proved non-inferior to ambroxol, another drug used to take care of patients with stubborn mucus secretions, when it comes to these outcomes, he reported at the European Respiratory Society (ERS) annual meeting.
“Overall, the analysis provides new evidence to aid the efficacy and safety of IV NAC as a mucolytic and expectorant treatment in clinical situations where in fact the IV route is recommended,” Papi stated.
NAC is among several treatments used as a mucolytic therapy, however the supporting evidence because of its efficacy and safety is sparse. Papi said just a couple of studies have examined IV NAC for this function, none with an increase of than 65 participants.
For the existing study, Papi and colleagues enrolled 333 patients admitted with abnormal mucus secretions and acute respiratory illnesses. The latter included chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, bronchiectasis, among others.
Sputum viscosity and expectoration difficulty, the trial’s two co-primary endpoints, were each scored on four-point categorical scales, where 0 represented normal function and 3 reflected severe abnormality (“sticky” for sputum viscosity, and “marked difficulty” with expectoration). Patients were included if their sputum was rated as sticky or viscous (score 2). Mean scores at baseline were about 2.2 both for sputum viscosity and expectoration difficulty.
Participants were randomized 1:1:1 to NAC, ambroxol, or placebo. Each was presented with by IV injection twice daily for seven days, at 600 mg for NAC and 30 mg for ambroxol. Mean patient age was 65 and about two-thirds were men. Roughly half were never-smokers; about 60% of these with a smoking history had quit.
There have been no differences between groups in sputum volume or changes in color, Papi said.
Adverse events (AEs) linked to treatment were equally normal with NAC and ambroxol, and severe/serious AEs were rare. Papi said the forms of AEs seen with NAC were exactly like reported in other studies.
Within an ERS discussion, Frits Franssen, MD, PhD, of Maastricht University in holland, commented that the trial raised numerous questions, especially about its design. For just one, he wondered if the 7-day treatment meant that hospitalization was extended for a few patients, for the reason that they could not otherwise have needed a complete week in a healthcare facility. Franssen also questioned the decision of IV injection over oral medication, which is easily available.
Papi responded that the investigators believed IV treatment could be more feasible in seriously ill patients “who may have difficulty with oral drugs,” and for that reason decided to concentrate on that in the trial.
Franssen also asked whether other medications patients were taking ahead of admission may have affected the outcomes. Papi replied that a lot of patients were also on antibiotics and some had used traditional Chinese medicines, but we were holding “balanced between your two groups” therefore shouldn’t have biased the outcomes.
John Gever was Managing Editor from 2014 to 2021; he could be now a normal contributor.
The analysis was supported by Zambon SpA.
Papi disclosed multiple relationships with industry including Zambon.