Trial reportAmerican journal of respiratory and critical care medicine2012
Fosfomycin/tobramycin for inhalation in patients with cystic fibrosis with pseudomonas airway infection.
Trial report in American journal of respiratory and critical care medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
47 citing papers in PubMed, 4 syntheses or guidelines pooled it, 114 citations in OpenAlex.
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2018Pooled it
- Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2017Pooled it
- Comparing inhaled colistin with inhaled fosfomycin/tobramycin as an adjunctive treatment for ventilator-associated pneumonia: An open-label randomized controlled trial.The clinical respiratory journal · 2023Trial
- Trial
- Review
- Comparative efficacy and safety of inhaled antibiotics in managing chronicJournal of thoracic disease · 2025Article
- DJK-5, an anti-biofilm peptide, increases Staphylococcus aureus sensitivity to colistin killing in co-biofilms with Pseudomonas aeruginosa.NPJ biofilms and microbiomes · 2025Article
- Overcoming the drug resistance barrier: progress in fosfomycin combination therapy against multidrug-resistant pathogens.Frontiers in microbiology · 2025Review
- Biofilm formation: mechanistic insights and therapeutic targets.Molecular biomedicine · 2023Review
- The Impact ofPathogens (Basel, Switzerland) · 2023Article
- Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2023Review
- Anti-Microorganisms · 2023Review
- Current and Emerging Inhaled Antibiotics for Chronic PulmonaryAntibiotics (Basel, Switzerland) · 2023Review
- Therapeutic Approach of ChronicAntibiotics (Basel, Switzerland) · 2021Article
- Itaconic Acid Increases the Efficacy of Tobramycin againstPharmaceutics · 2020Article
- A Multi-Scale Approach to Investigate Adhesion Properties ofFoods (Basel, Switzerland) · 2020Article
- Calculated parenteral initial treatment of bacterial infections: Infections with multi-resistant Gram-negative rods - ESBL producers, carbapenemase-producing Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii.GMS infectious diseases · 2020Article
- Prevention of chronic infection with Pseudomonas aeruginosa infection in cystic fibrosis.Current opinion in pulmonary medicine · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 7 institutions in 1 country.
Funding
Abstract
rationaleFosfomycin/tobramycin for inhalation (FTI), a unique, broad-spectrum antibiotic combination, may have therapeutic potential for patients with cystic fibrosis (CF).
objectivesTo evaluate safety and efficacy of FTI (160/40 mg or 80/20 mg), administered twice daily for 28 days versus placebo, in patients greater than or equal to 18 years of age, with CF, chronic Pseudomonas aeruginosa (PA) airway infection, and FEV(1) greater than or equal to 25% and less than or equal to 75% predicted.
methodsThis double-blind, placebo-controlled, multicenter study assessed whether FTI/placebo maintained FEV(1) % predicted improvements achieved following a 28-day, open-label, run-in course of aztreonam for inhalation solution (AZLI). MEASUREMENTS AND MAIN
resultsA total of 119 patients were randomized to FTI (160/40 mg: n = 41; 80/20 mg: n = 38) or placebo (n = 40). Mean age was 32 years and mean FEV(1) was 49% predicted at screening. Relative improvements in FEV(1) % predicted achieved by the AZLI run-in were maintained in FTI groups compared with placebo (160/40 mg vs. placebo: 6.2% treatment difference favoring FTI, P = 0.002 [primary endpoint]; 80/20 mg vs. placebo: 7.5% treatment difference favoring FTI, P < 0.001). The treatment effect on mean PA sputum density was statistically significant for the FTI 80/20 mg group versus placebo (-1.04 log(10) PA colony-forming units/g sputum difference, favoring FTI; P = 0.01). Adverse events, primarily cough, were consistent with CF disease. Respiratory events, including dyspnea and wheezing, were less common with FTI 80/20 mg than FTI 160/40 mg. No clinically significant differences between groups were reported for laboratory values.
conclusionsFTI maintained the substantial improvements in FEV(1) % predicted achieved during the AZLI run-in and was well tolerated. FTI is a promising antipseudomonal therapy for patients with CF.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.