Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study

• Published in: The European respiratory journal Vol. 41; no. 5; pp. 1107 - 1115
• Main Authors: Wilson, Robert, Welte, Tobias, Polverino, Eva, De Soyza, Anthony, Greville, Hugh, O'Donnell, Anne, Alder, Jeff, Reimnitz, Peter, Hampel, Barbara
• Format: Journal Article
• Language: English
• Published: Leeds Maney 01.05.2013; European Respiratory Society
• Subjects: Administration, Inhalation; Aged; Anti-Bacterial Agents - administration & dosage; Bacterial Load; Biological and medical sciences; Bronchiectasis - drug therapy; Ciprofloxacin - administration & dosage; Colony Count, Microbial; Double-Blind Method; Drug Administration Schedule; Dry Powder Inhalers; Errors of metabolism; Female; General aspects; Human infectious diseases. Experimental studies and models; Humans; Infectious diseases; Inflammation; Lung Diseases - drug therapy; Male; Medical sciences; Metabolic diseases; Middle Aged; Miscellaneous hereditary metabolic disorders; Original; Pneumology; Powders; Pseudomonas aeruginosa; Respiratory system : syndromes and miscellaneous diseases; Treatment Outcome; Pseudomonadales; Nosocomial infection; Lung; Dry; Powder; Randomization; Phase II trial; Bronchus disease; Pseudomonadaceae; Bacteria; Pseudomonas aeruginosa; Pancreatic disease; Respiratory disease; chronic lung infection; Metabolic diseases; Cystic fibrosis; Bronchiectasis; Inflammation; Genetic disease; Inhalation; exacerbation; Infection; Antibiotic; Chronic; Bacteriosis; Digestive diseases; Antibacterial agent; Ciprofloxacin; bacteria; inflammation
• ISSN: 0903-1936; 1399-3003; 1399-3003
• DOI: 10.1183/09031936.00071312

This phase II, randomised, double-blind, multicentre study ( NCT00930982 ) investigated the safety and efficacy of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis. Adults who were culture positive for pre-defined potential respiratory pathogens (including Pseudomonas aeruginosa and Haemophilus influenzae ) were randomised to ciprofloxacin DPI 32.5 mg or placebo administered twice daily for 28 days (with 56 days of follow-up). Bacterial density in sputum (primary end-point), pulmonary function tests, health-related quality of life and safety were monitored throughout the study. 60 subjects received ciprofloxacin DPI 32.5 mg and 64 received placebo. Subjects on ciprofloxacin DPI had a significant reduction (p<0.001) in total sputum bacterial load at the end of treatment (-3.62 log 10 CFU·g −1 (range -9.78–5.02 log 10 CFU·g −1 )) compared with placebo (-0.27 log 10 CFU·g −1 (range -7.96–5.25 log 10 CFU·g −1 )); the counts increased thereafter. In the ciprofloxacin DPI group, 14 (35%) out of 40 subjects reported pathogen eradication at end of treatment versus four (8%) out of 49 in the placebo group (p=0.001). No abnormal safety results were reported and rates of bronchospasm were low. Ciprofloxacin DPI 32.5 mg twice daily for 28 days was well tolerated and achieved significant reductions in total bacterial load compared with placebo in subjects with non-cystic fibrosis bronchiectasis.