Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis

Abstract Background Inhaled antibiotics are standard of care for treating chronic pseudomonal respiratory infections in cystic fibrosis patients, initially approved for intermittent administration. However, use of continuous inhaled antibiotic regimens of differing combinations is growing. Methods T...

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Bibliographic Details
Published in:	Journal of cystic fibrosis Vol. 15; no. 6; pp. 809 - 815
Main Authors:	Flume, Patrick A, Clancy, John P, Retsch-Bogart, George Z, Tullis, D. Elizabeth, Bresnik, Mark, Derchak, P. Alex, Lewis, Sandra A, Ramsey, Bonnie W
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-11-2016
Subjects:	Administration, Inhalation Adolescent Adult Aerosol Anti-Bacterial Agents - administration & dosage Antibiotics Aztreonam - administration & dosage Chronic Disease Cystic fibrosis Cystic Fibrosis - diagnosis Cystic Fibrosis - drug therapy Double-Blind Method Female Forced Expiratory Volume - drug effects Humans Male Medication Therapy Management Pseudomonas Pseudomonas aeruginosa - isolation & purification Pseudomonas Infections - diagnosis Pseudomonas Infections - drug therapy Pulmonary exacerbation Pulmonary/Respiratory Respiratory Tract Infections - diagnosis Respiratory Tract Infections - drug therapy Time Factors Tobramycin - administration & dosage Treatment Outcome not estimable Cystic Fibrosis Respiratory Symptom Diary–Chronic Respiratory Infection Symptom Score MIC Aerosol AZLI Cystic fibrosis Pseudomonas continuous alternating therapy minimum inhibitory concentration PA CFQ-R RSS Antibiotics CAT Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Symptoms Scale NE aztreonam for inhalation solution mixed effect model repeated measures Pseudomonas aeruginosa tobramycin inhalation solution CFRSD–CRISS Pulmonary exacerbation MMRM TIS
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Summary:	Abstract Background Inhaled antibiotics are standard of care for treating chronic pseudomonal respiratory infections in cystic fibrosis patients, initially approved for intermittent administration. However, use of continuous inhaled antibiotic regimens of differing combinations is growing. Methods This double-blind trial compared continuous alternating therapy (CAT) to an intermittent treatment regimen. Subjects were treated with 3 cycles of 28-days inhaled aztreonam (AZLI) or placebo 3-times daily alternating with 28-days open-label tobramycin inhalation solution (TIS). Results 90 subjects were randomized over 18 months. Study enrollment was limited, in part because of evolving practices by clinicians of adopting a CAT regimen in clinical practice; consequently the study was underpowered. AZLI/TIS treatment reduced exacerbation rates by 25.7% (p = 0.25; primary endpoint) and rates of respiratory hospitalizations by 35.8% compared with placebo/TIS (p = 0.14). AZLI/TIS CAT therapy was well tolerated. Conclusions This trial illustrates challenges with studying treatment regimens in a constantly evolving CF care environment. Nonetheless, the results of this trial indicate that AZLI/TIS CAT is well tolerated and may provide additional clinical benefit in CF patients compared with intermittent use of TIS alone. Clinicaltrials.gov: NCT01641822.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23
ISSN:	1569-1993 1873-5010
DOI:	10.1016/j.jcf.2016.05.001