Trial reportBMC infectious diseases2025
Efficacy and safety of inhaled ambroxol hydrochloride solution in patients with lower respiratory tract infectious diseases: a randomized, double-blind, placebo-controlled, multicentre clinical trial.
Trial report in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Network meta-analysis of pharmacological treatments for idiopathic pulmonary fibrosis: evaluating effects on lung function.Frontiers in pharmacology · 2026Pooled it
- 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
- Development and Systematic Evaluation of a Low-Irritation PFD-AIS Formulation for Pulmonary-Targeted Therapy.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Association between terbutaline sulfate plus ambroxol hydrochloride and clinical outcomes, pulmonary function, and inflammatory biomarkers in elderly patients with acute exacerbation of chronic obstructive pulmonary disease.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAmbroxol is a widely used mucoactive agent, but the efficacy of inhaled ambroxol in patients with lower respiratory tract infectious (LRTI) disease is poorly understood. This trial aimed to compare the efficacy and safety of inhaled ambroxol with those of placebo in patients with LRTI diseases.
methodsIn this randomized, double-blind, placebo-controlled, multicentre clinical trial, 240 patients with LRTI diseases were randomized to receive inhaled ambroxol hydrochloride solution (ambroxol group, N = 120) or placebo (placebo group, N = 120) twice daily for 7 days.
resultsCompared with the placebo group, the ambroxol group had lower sputum trait scores and greater changes in sputum trait scores from Day 2 to Day 8. Compared with the placebo group, the ambroxol group presented lower expectoration difficulty scores and greater changes in expectoration difficulty scores on Days 2, 3, and 6. The sputum volume scores on Days 6, 7, and 8 were lower in the ambroxol group than in the placebo group, but the change in the sputum volume score was not different between the groups. Compared with the placebo group, the ambroxol group had lower cough scores on Days 3, 5, 6, and 7, as well as greater changes in cough scores on Days 2, 3, and 5. The incidences of adverse events (10.8% versus 6.7%), serious adverse events (0.8% versus 0.0%), and adverse reactions (4.2% versus 3.3%) were not different between the ambroxol group and the placebo group.
conclusionsInhaled ambroxol is better at ameliorating respiratory symptoms and has comparable safety to placebo in patients with LRTI diseases.
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