Trial reportPediatric pulmonology2011
Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: the EVOLVE trial.
Trial report in Pediatric pulmonology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 6 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
58 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Brazilian guidelines for the pharmacological treatment of the pulmonary symptoms of cystic fibrosis. Official document of the Sociedade Brasileira de Pneumologia e Tisiologia (SBPT, Brazilian Thoracic Association).Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2023Guideline
- 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
- The burden, epidemiology, costs and treatment for Duchenne muscular dystrophy: an evidence review.Orphanet journal of rare diseases · 2017Pooled it
- Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2017Pooled it
- Altered Degranulation and pH of Neutrophil Phagosomes Impacts Antimicrobial Efficiency in Cystic Fibrosis.Frontiers in immunology · 2020Trial
- Ease of use of tobramycin inhalation powder compared with nebulized tobramycin and colistimethate sodium: a crossover study in cystic fibrosis patients with pulmonary Pseudomonas aeruginosa infection.Therapeutic advances in respiratory disease · 2017Trial
- Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial.Current medical research and opinion · 2013Trial
- Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2011Trial
- Systematic Review of Antimicrobial Therapies and Clinical Outcomes inLife (Basel, Switzerland) · 2026Review
- The Next Frontier: Unveiling Novel Approaches for Combating Multidrug-Resistant Bacteria.Pharmaceutical research · 2025Review
- Comparative efficacy and safety of inhaled antibiotics in managing chronicJournal of thoracic disease · 2025Article
- Targeted delivery of antitubercular drugs using glucan lipid particles.Microbiology spectrum · 2025Article
- Pulmonary Delivery of Antibiotics to the Lungs: Current State and Future Prospects.Pharmaceutics · 2025Review
- Therapeutic Interventions forJournal of clinical medicine · 2024Review
- Nanoparticles as Drug Delivery Vehicles for People with Cystic Fibrosis.Biomimetics (Basel, Switzerland) · 2024Review
- Inhalable tobramycin EEG powder formulation for treating Pseudomonas aeruginosa-induced lung infection.International journal of pharmaceutics · 2024Article
- Limited effects of azithromycin on the oropharyngeal microbiome in children with CF and early pseudomonas infection.BMC microbiology · 2023Article
- Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
Tobramycin inhalation solution is used to treat chronic Pseudomonas aeruginosa lung infection in cystic fibrosis (CF) patients. We evaluated the efficacy and safety of a novel, light-porous particle, dry-powder formulation of tobramycin, which was developed to improve delivery efficiency to the airways and substantially reduce the delivery time. In this randomized, double-blind study, patients with CF (age 6-21 years) received tobramycin inhalation powder (112 mg tobramycin) twice daily (n = 46) or placebo (n = 49) via the T-326 Inhaler for one cycle, followed by two open-label cycles (all patients). Cycles were 28 days on, 28 days off treatment. The primary endpoint was change in forced expiratory volume in 1 sec (FEV1) % predicted from baseline to Day 28 of Cycle 1. The study was terminated early based on positive results in the interim analysis. Tobramycin inhalation powder significantly improved FEV1 % predicted versus placebo at Day 28 (difference 13.3, 95% CI: 5.31-21.28; P = 0.0016). Similar changes in FEV1 were seen in patients switching from placebo to tobramycin inhalation powder in Cycle 2; improvements were maintained over time. Tobramycin inhalation powder also reduced sputum P. aeruginosa density, respiratory-related hospitalization and antipseudomonal antibiotic use versus placebo. The most common adverse event was cough; the frequency of cough was higher in patients receiving placebo (26.5%) versus tobramycin inhalation powder (13.0%) in Cycle 1. Tobramycin inhalation powder was not associated with ototoxicity or nephrotoxicity. Administration time was between 4 and 6 min. In conclusion, tobramycin inhalation powder was effective and well tolerated in CF patients, and may offer an important treatment option to decrease the treatment burden of CF pseudomonas lung infections.
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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.