Effect of multiple aztreonam lysine for inhalation (AZLI) cycles on disease-related endpoints and safety in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA): Interim analysis of 12 month data

Oermann, Christopher M.; McCoy, Karen; Retsch-Bogart, G.; Gibson, Ronald L.; Quittner, A.L.; Montgomery, A. Bruce

doi:10.1016/s1569-1993(08)60097-1

Cited by 5 publications

(4 citation statements)

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“…Existing long-term therapies used in patients with CF have typically been assessed in controlled trials with a duration of 6 months. 23,28,30 An open-label, 18-month clinical trial 31 of AZLI (intermittent treatment every other month) is ongoing to address the efficacy and safety of long-term suppressive therapy.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Inhaled Aztreonam Lysine for Airway Pseudomonas in Cystic Fibrosis

Retsch‐Bogart

Quittner

Gibson

et al. 2009

Chest

259

236

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Results: After 28 days of treatment, AZLI improved the mean CFQ-R respiratory score (9.7 points; p < 0.001), FEV 1 (10.3% predicted; p < 0.001), and sputum PA density (؊ 1.453 log 10 cfu/g; p < 0.001), compared with placebo. Significant improvements in Eating, Emotional Functioning, Health Perceptions, Physical Functioning, Role Limitation/School Performance, and Vitality CFQ-R scales were observed. Adverse events were consistent with symptoms of CF lung disease and were comparable for AZLI and placebo except the incidence of "productive cough" was reduced by half in AZLI-treated patients. PA aztreonam susceptibility at baseline and end of therapy were similar. Conclusions: In patients with CF, PA airway infection, moderate-to-severe lung disease, and no recent use of antipseudomonal antibiotics or azithromycin, 28-day treatment with AZLI significantly improved respiratory symptoms and pulmonary function, and was well tolerated.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Inhaled Aztreonam Lysine for Airway Pseudomonas in Cystic Fibrosis

Retsch‐Bogart

Quittner

Gibson

et al. 2009

Chest

259

236

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“…Data suggest that improvements in disease-related endpoints (FEV 1 , CFQ-R respiratory symptom score, and sputum P. aeruginosa density) generally persist over time during on-treatment cycles. Patients receiving AZLI three times daily had more favorable results as compared with those receiving AZLI twice daily 38,39. However, owing to the lack of detail regarding study procedures, it is difficult to draw substantial conclusions at this time.…”

Section: Efficacymentioning

confidence: 96%

“…Data from an open-label follow-on study (AIR CF-3) have been published in abstract form. 38 – 40 According to data released in the abstracts, 274 patients who originally took part in AIR CF-1 or AIR CF-2 were continued on up to nine 28-day on, 28-day off cycles of AZLI. AZLI was administered at a dose of 75 mg twice daily or three times daily (as determined by the original study).…”

Section: Efficacymentioning

confidence: 99%

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Clinical perspective on aztreonam lysine for inhalation in patients with cystic fibrosis

Daddario

Hagerman²,

Klepser

2010

IDR

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Progressive obstructive lung disease is a characteristic component of cystic fibrosis (CF). It is the pulmonary manifestations, including obstruction and endobronchial infection, which directly contribute to the premature mortality of patients affected with CF. Due to the devastating effects on the pulmonary system, interest abounds in ways to improve antimicrobial delivery to the lungs and to impact clinical patient outcomes positively, whilst minimizing systemic toxicities. Recently, aztreonam lysine for inhalation solution, a new monobactam formulation, was approved by the US Food and Drug Administration for use in a subgroup of CF patients with Pseudomonas aeruginosa to improve respiratory symptoms. The purpose of this review is to present a summary of relevant pharmacologic, microbiologic, and clinical data related to the use of aztreonam lysine for inhalation in patients with CF.

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Treatment strategies for cystic fibrosis: what's in the pipeline?

Frerichs

Smyth

2009

Expert Opinion on Pharmacotherapy

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Effect of multiple aztreonam lysine for inhalation (AZLI) cycles on disease-related endpoints and safety in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA): Interim analysis of 12 month data

Cited by 5 publications

References 0 publications

Efficacy and Safety of Inhaled Aztreonam Lysine for Airway Pseudomonas in Cystic Fibrosis

Efficacy and Safety of Inhaled Aztreonam Lysine for Airway Pseudomonas in Cystic Fibrosis

Clinical perspective on aztreonam lysine for inhalation in patients with cystic fibrosis

Treatment strategies for cystic fibrosis: what's in the pipeline?

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