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Published on: March 17, 2014
Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis
Patrick A Flume1, John P Clancy2, George Z Retsch-Bogart3
1Medical University of South Carolina, 96 Jonathan Lucas Street, 812-CSB, Charleston, SC 29425, USA.
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 3cycles 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 18months. 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.
Insights
Continuous alternating inhaled aztreonam/tobramycin (AZLI/TIS) therapy may benefit cystic fibrosis patients with chronic pseudomonal infections. This regimen was well tolerated and showed a trend toward reduced exacerbations and hospitalizations.
Area of Science:
- Pulmonology
- Infectious Diseases
- Pharmacology
Background:
- Inhaled antibiotics are crucial for cystic fibrosis (CF) patients with chronic pseudomonal respiratory infections.
- While initially approved for intermittent use, continuous inhaled antibiotic regimens are increasingly adopted.
- This study investigates a continuous alternating therapy (CAT) regimen in CF care.
Purpose of the Study:
- To compare the efficacy and safety of continuous alternating therapy (CAT) with intermittent inhaled antibiotic regimens in CF patients.
- To evaluate the impact of AZLI/TIS CAT on exacerbation rates and respiratory hospitalizations.
Main Methods:
- A double-blind, randomized trial comparing continuous alternating therapy (CAT) to intermittent treatment.
- Subjects received 28-day cycles of inhaled aztreonam (AZLI) or placebo, alternating with 28-day open-label tobramycin inhalation solution (TIS).
- 90 subjects were randomized over 18 months.
Main Results:
- The study was underpowered due to evolving clinical practices favoring CAT.
- AZLI/TIS CAT showed a 25.7% reduction in exacerbation rates (p=0.25) and a 35.8% reduction in respiratory hospitalizations (p=0.14) compared to placebo/TIS.
- The AZLI/TIS CAT regimen was well tolerated by participants.
Conclusions:
- Studying treatment regimens in the dynamic CF care environment presents challenges.
- Results suggest AZLI/TIS CAT is well-tolerated and may offer additional clinical benefits over intermittent TIS alone in CF patients.
- Further research is warranted to confirm the efficacy of continuous inhaled antibiotic strategies.
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