Trial reportCurrent medical research and opinion2013
Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial.
Trial report in Current medical research and opinion, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00918957 (A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis), which is not on this map. Cited by 16 papers, 1 of them a synthesis 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.
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- 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
- Comparative efficacy and safety of inhaled antibiotics in managing chronicJournal of thoracic disease · 2025Article
- Therapeutic Interventions forJournal of clinical medicine · 2024Review
- Nanoparticles as Drug Delivery Vehicles for People with Cystic Fibrosis.Biomimetics (Basel, Switzerland) · 2024Review
- Article
- Efficacy and Safety of Dry Powder Antibiotics: A Narrative Review.Journal of clinical medicine · 2023Review
- Dry Powder Inhalation for Lung Delivery in Cystic Fibrosis.Pharmaceutics · 2023Review
- Therapeutic Approach of ChronicAntibiotics (Basel, Switzerland) · 2021Article
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2018Review
- Inhaled Antibiotic Therapy in Chronic Respiratory Diseases.International journal of molecular sciences · 2017Review
- Tobramycin inhalation powder for the treatment of pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis: a review based on clinical evidence.Therapeutic advances in respiratory disease · 2017Review
- Pharmacokinetics and pharmacodynamics of aerosolized antibacterial agents in chronically infected cystic fibrosis patients.Clinical microbiology reviews · 2014Review
- Tobramycin Inhalation Powder (TIP): An Efficient Treatment Strategy for the Management of Chronic Pseudomonas Aeruginosa Infection in Cystic Fibrosis.Clinical medicine insights. Circulatory, respiratory and pulmonary medicine · 2013Review
- Review
- Treatment of pseudomonas and Staphylococcus bronchopulmonary infection in patients with cystic fibrosis.TheScientificWorldJournal · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundTobramycin inhalation powder (TIP) was reported to be effective in two Phase III studies in patients with cystic fibrosis (CF) chronically infected with Pseudomonas aeruginosa (Pa). The EDIT study evaluated the efficacy and safety of TIP manufactured by an improved process in CF subjects aged 6-21 years.
methodsCF patients with a forced expiratory volume in 1 second (FEV₁) ≥25% to ≤80% predicted, positive Pa cultures and inhaled antipseudomonal therapy naïve (or at least for past 4 months) were enrolled into this double-blind, multicenter trial. Patients were randomized to receive TIP or placebo (1:1) twice daily for one treatment cycle (28.5 days on drug, 28 days off drug). The primary endpoint was relative change in FEV₁ percentage predicted from baseline to day 29. A pre-specified sensitivity analysis evaluated absolute change in FEV₁% predicted. Other endpoints included Pa sputum density and safety.
resultsA total of 62 patients out of a target of 100 (mean age 12.9 years, baseline FEV₁ 59.2% predicted, Pa sputum density 7.4 log₁₀ colony forming units [CFU] per gram) were randomized. Mean treatment differences (TIP - placebo) were 5.9% (p=0.148) and 4.4% (p<0.05) for relative and absolute change in FEV₁% predicted respectively. TIP significantly reduced Pa sputum density by -1.2 log10 CFU (p=0.002). Treatment with TIP was well tolerated.
conclusionsRelative change in FEV₁% predicted with TIP treatment was in the expected range based on the literature, but did not reach statistical significance versus placebo. Placebo control and use of treatment naïve patients led to significant recruitment challenges and an underpowered study with consequent impact on the generated data. However, significant improvements in other outcomes including absolute change in FEV₁% predicted and reduction in Pa sputum density indicate that TIP is efficacious and well tolerated in CF patients. CLINICALTRIALS.GOV IDENTIFIER: NCT00918957.
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