Trial reportBMC pulmonary medicine2025
Efficacy and safety of inhaled ambroxol solution in improving sputum of lower respiratory tract infection in children: a multicenter, randomized, double-blind, placebo-controlled trial.
Trial report in BMC pulmonary medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Efficacy and safety of inhaled ambroxol hydrochloride solution in Chinese pediatric patients with acute lower respiratory tract infections: a real-world, multicenter, open-label, single-arm study.Translational pediatrics · 2026Article
- Ambroxol hydrochloride and clenbuterol hydrochloride oral solution versus ambroxol hydrochloride injection for pediatric lower respiratory tract infection with mucoid sputum: a multicenter, non-randomized observational study in China.Translational pediatrics · 2026Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of inhaled ambroxol solution in improving sputum of lower respiratory tract infections (LRTIs) in children. STUDY
designThis study was a randomized, double-blind, parallel-group, placebo-controlled, multicenter trial. The patients were administered inhaled ambroxol or a placebo twice a day for 7 days. And researchers collected efficacy and (or) safety indicators every day during the course.
resultsA total of 236 children were randomly assigned to receive ambroxol or placebo (1:1). At all visit points after the medication, the mean difference of cough score with the baseline between the two groups was statistically significant (P < 0.05). Compared with the baseline, the phlegm-sound scores in the throat of the experimental group decreased more on the 1st, 2nd, and 3rd days after administration (P < 0.05). But there was no difference in pulmonary rale scores. The occurrence of adverse events in the experimental group was lower (21.37% vs. 35.59%, P = 0.021), and the incidence of adverse reactions was similar between the two groups (2.56% vs. 5.08%, P = 0.499).
conclusionInhaled ambroxol solution could improve the sticky sputum symptoms in children with LRTIs and is safe in clinical application. Further research is needed to confirm these findings.
trial registrationThe study was retrospectively registered on June 14, 2023, at https://www.chictr.org.cn/ under the number ChiCTR2300072466.
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