Trial reportBMJ open respiratory research2025
Safety and efficacy of inhalable ambroxol hydrochloride aerosol for adult patients with respiratory diseases: an open-label, single-arm, multicentre study.
Trial report in BMJ open respiratory research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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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
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
38 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAirway mucus hypersecretion is a key pathophysiological feature in many respiratory diseases and could lead to airway obstruction and repeated infections, consequently accelerating disease progression, which impacts on pulmonary function and quality of life (QoL), highlighting the importance of mucolytic therapy targeting airway mucus hypersecretion.
objectivesTo investigate the safety and efficacy of inhalable ambroxol hydrochloride aerosol for adult patients with respiratory diseases.
designAn open-label, single-arm, multicentre postmarketing surveillance study.
methodsAdult patients with acute or chronic respiratory diseases were eligible to receive aerosol inhalation of ambroxol hydrochloride (3 mL and 7.5 mg/mL) using a nebuliser two times per day given at least 6 hours apart between doses. The treatment lasted for a maximum of 7 days. The primary safety outcome was the frequency and severity of adverse events (AEs), and the primary efficacy outcome was changes in sputum scale scores.
resultsAmong 1201 eligible patients, 1192 received study medication and were included in the full analysis set and the safety set. Any grade AEs occurred in 16.3% of the patients, including serious AEs in four (0.3%) patients. The three most frequent AEs were respiratory symptoms and signs (1.5%), nausea and vomiting (0.8%) and digestive tract symptoms and signs (0.7%). In the full analysis set, the patients showed a mean reduction of 77.6% (95% CI, 75.9% to 79.3%) in the sputum scale score at the end of treatment, with a mean difference of -1.7±0.7 from baseline (p<0.001).
conclusionInhalable ambroxol hydrochloride aerosol is well tolerated and effective in easing expectoration and alleviating cough, reducing sputum and improving the QoL of adult patients with acute and chronic respiratory diseases. TRIAL REGISTRATION NUMBER: ChiCTR2100043736.
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