Cargando…
Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis
BACKGROUND: Treatment 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...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4680008/ https://www.ncbi.nlm.nih.gov/pubmed/26688732 http://dx.doi.org/10.1136/bmjresp-2015-000100 |
_version_ | 1782405621760393216 |
---|---|
author | Dorkin, Henry L Staab, Doris Operschall, Elisabeth Alder, Jeff Criollo, Margarita |
author_facet | Dorkin, Henry L Staab, Doris Operschall, Elisabeth Alder, Jeff Criollo, Margarita |
author_sort | Dorkin, Henry L |
collection | PubMed |
description | BACKGROUND: Treatment 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. METHODS: Patients 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. RESULTS: The 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). CONCLUSIONS: Further 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. |
format | Online Article Text |
id | pubmed-4680008 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-46800082015-12-18 Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis Dorkin, Henry L Staab, Doris Operschall, Elisabeth Alder, Jeff Criollo, Margarita BMJ Open Respir Res Cystic Fibrosis BACKGROUND: Treatment 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. METHODS: Patients 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. RESULTS: The 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). CONCLUSIONS: Further 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. BMJ Publishing Group 2015-12-02 /pmc/articles/PMC4680008/ /pubmed/26688732 http://dx.doi.org/10.1136/bmjresp-2015-000100 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Cystic Fibrosis Dorkin, Henry L Staab, Doris Operschall, Elisabeth Alder, Jeff Criollo, Margarita Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis |
title | Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis |
title_full | Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis |
title_fullStr | Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis |
title_full_unstemmed | Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis |
title_short | Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis |
title_sort | ciprofloxacin dpi: a randomised, placebo-controlled, phase iib efficacy and safety study on cystic fibrosis |
topic | Cystic Fibrosis |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4680008/ https://www.ncbi.nlm.nih.gov/pubmed/26688732 http://dx.doi.org/10.1136/bmjresp-2015-000100 |
work_keys_str_mv | AT dorkinhenryl ciprofloxacindpiarandomisedplacebocontrolledphaseiibefficacyandsafetystudyoncysticfibrosis AT staabdoris ciprofloxacindpiarandomisedplacebocontrolledphaseiibefficacyandsafetystudyoncysticfibrosis AT operschallelisabeth ciprofloxacindpiarandomisedplacebocontrolledphaseiibefficacyandsafetystudyoncysticfibrosis AT alderjeff ciprofloxacindpiarandomisedplacebocontrolledphaseiibefficacyandsafetystudyoncysticfibrosis AT criollomargarita ciprofloxacindpiarandomisedplacebocontrolledphaseiibefficacyandsafetystudyoncysticfibrosis |