ArticleBMJ open respiratory research2015
Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis.
Article in BMJ open respiratory research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00645788 (Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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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.
Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis
Who cites it
13 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
- Comparative efficacy and safety of inhaled antibiotics in managing chronicJournal of thoracic disease · 2025Article
- Therapeutic Interventions forJournal of clinical medicine · 2024Review
- Ciprofloxacin-Loaded Inhalable Formulations against Lower Respiratory Tract Infections: Challenges, Recent Advances, and Future Perspectives.Pharmaceutics · 2024Review
- Nano-Formulations for Pulmonary Delivery: Past, Present, and Future Perspectives.Pharmaceutics · 2024Review
- 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
- Comparison of Phospholipid-Based Particles for Sustained Release of Ciprofloxacin Following Pulmonary Administration to Bronchiectasis Patients.Pulmonary therapy · 2019Review
- Pragmatic criteria to define chronic pseudomonas aeruginosa infection among adults with cystic fibrosis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2018Article
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2018Review
- Dry powder aerosols to co-deliver antibiotics and nutrient dispersion compounds for enhanced bacterial biofilm eradication.International journal of pharmaceutics · 2017Article
- Inhaled Antibiotic Therapy in Chronic Respiratory Diseases.International journal of molecular sciences · 2017Review
- Ciprofloxacin dry powder inhaler in cystic fibrosis.BMJ open respiratory research · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment of infective bronchitis involving Pseudomonas aeruginosa is a cornerstone of care in patients with cystic fibrosis (CF). This phase IIb, randomised, double-blind, placebo-controlled study assessed the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in this population.
methodsPatients with CF, ≥12 years of age (N=286), were randomised to ciprofloxacin DPI (32.5 mg (n=93) or 48.75 mg (n=93)), or corresponding placebo (32.5 mg, n=65; 48.75 mg, n=35) twice daily for 28 days. The primary objective was the change in forced expiratory volume in 1 s (FEV1) from baseline (day 0) to end of treatment (day 29) in the intent-to-treat population for ciprofloxacin DPI compared with the corresponding placebo group.
resultsThe primary effectiveness objective was not met; there were no significant differences in change in FEV1 between ciprofloxacin DPI and the corresponding placebo group for either dose (p=0.154). However, in pooled analyses, FEV1 decline from baseline to treatment end was significantly lower with ciprofloxacin DPI than with placebo (pooled data; p=0.02). Ciprofloxacin DPI showed positive effects on sputum bacterial load and quality of life, but these effects were not maintained at the 4-week follow-up. Ciprofloxacin DPI was well tolerated and there were no significant differences in type/incidence of treatment-emergent adverse events by treatment group (p=0.115).
conclusionsFurther investigations are needed to determine the full scope of the beneficial effects of ciprofloxacin DPI for patients with CF. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT00645788; EudraCT 2008-008314-40.
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