A controlled trial of nebulized aminoglycoside and oral flucloxacillin versus placebo in the outpatient management of children with cystic fibrosis

Carswell, F.; Ward, Chris; Cook, David Angus Graham; Speller, D. C. E.

doi:10.1016/0007-0971(87)90184-7

Cited by 60 publications

(21 citation statements)

References 3 publications

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“…[3][4][5][6][7][8][9][10][11][12][13][14][15][16][17] However, none of these agents have been approved for inhalation and studies evaluating their efficacy have substantial problems in study design, including: small sample size, inadequate blinding of participants, lack of appropriate controls, and failure to consider potential carryover effects in crossover designs. Other aminoglycosides, 18 -20 vancomycin, 21,22 and polymyxin 23 also have been administered by inhalation in different circumstances to patients without CF.…”

Section: Approved Indication For Tobramycin Solution For Inhalation (mentioning

confidence: 99%

Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics

Prober¹,

Walson²,

Jones³

2000

Pediatrics

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ABSTRACT. In 1998, the Food and Drug Administration (FDA) approved the licensure of tobramycin solution for inhalation (TOBI). Although a number of additional antibiotics, including other aminoglycosides, ␤-lactams, antibiotics in the polymyxin class, and vancomycin, have been administered as aerosols for many years, none are approved by the FDA for administration by inhalation.TOBI was approved by the FDA for the maintenance therapy of patients 6 years or older with cystic fibrosis (CF) who have between 25% and 75% of predicted forced expiratory volume in 1 second (FEV 1 ), are colonized with Pseudomonas aeruginosa, and are able to comply with the prescribed medical regimen. TOBI was not approved for the therapy of acute pulmonary exacerbations in patients with CF nor was it approved for use in patients without CF. Currently, no other antibiotics are approved for administration by inhalation to patients with or without CF.The purpose of this statement is to briefly summarize the data that supported approval for licensure of TOBI and to provide recommendations for its safe use. The pharmacokinetics of inhaled aminoglycosides and problems associated with aerosolized antibiotic treatment, including environmental contamination, selection of resistant microbes, and airway exposure to excipients in intravenous formulations, will be discussed. Pediatrics 2000;106(6). URL: http://www.pediatrics.org/cgi/content/ full/106/6/e89; aerosolized antibiotics, tobramycin solution for inhalation; cystic fibrosis; Pseudomonas aeruginosa.ABBREVIATIONS. TOBI, tobramycin solution for inhalation; CF, cystic fibrosis; FEV 1 , forced expiratory volume in 1 second; FDA, Food and Drug Administration; MIC, minimal inhibitory concentration. APPROVED INDICATION FOR TOBRAMYCIN SOLUTION FOR INHALATION (TOBI)TOBI is approved for maintenance therapy of patients with cystic fibrosis (CF) who are known to be colonized with Pseudomonas aeruginosa. The results of 2 randomized, double-blind, placebo-controlled, multicentered, 24-week clinical studies demonstrated the favorable effects of this therapy. 1,2 Each study enrolled subjects 6 years or older who had Ն25% and Յ75% of predicted forced expiratory volume in 1 second (FEV 1 ). Subjects with serum creatinine concentrations above 2 mg/dL and those colonized with Burkholderia cepacia were excluded. Study participants received alternating 28-day cycles of drug therapy. Two hundred fifty-eight patients received 300 mg of TOBI twice daily and 262 received inhaled saline placebo. Both drug and placebo were delivered by a PARI LC Plus nebulizer (PARI Respiratory Equipment Inc, Monterey, CA) with a Pulmo-Aide compressor (DeVilbiss Air Power Co, Jackson, TN). The drug recipients experienced significant improvement in pulmonary function compared with the placebo recipients; the average improvement in FEV 1 at the end of the study (week 24) relative to baseline (week 0) was 7% to 11% in the treatment group versus 0% to 1% in the placebo group (P Ͻ .001). Furthermore, TOBI resulted in a significant reduction...

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Section: Approved Indication For Tobramycin Solution For Inhalation (mentioning

confidence: 99%

Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics

Prober¹,

Walson²,

Jones³

2000

Pediatrics

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“…On a short-term basis this seems to be effective [12,85], but long-term studies are needed. Oral anti-pseudomonal antibiotics, the quinolones, recently became available.…”

Section: General Considerationsmentioning

confidence: 99%

Cystic fibrosis, pathophysiological and clinical aspects

et al. 1990

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Cystic fibrosis is a lethal, hereditary, until recently little understood disease, which leads to progressive functional disturbances in various organs, including the lungs, liver and pancreas. Knowledge of the genetic and cellular abnormalities is rapidly progressing, but therapy is still symptomatic and based on insufficiently controlled and short-term studies. At present the therapeutic approach aims to combat respiratory infections by optimal antibiotic therapy, combined with techniques to promote sputum evacuation. Additional measures attempt to optimise both nutritional state and physical condition. Median survival has improved from approximately 1 year to about 25 years during the past 3 decades. This article summarises present information on disease mechanisms and treatment.

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“…Six children with P. aeruginosa isolated from their respiratory tract completed a randomized crossover study of oral flucloxacillin and nebulized aminoglycoside versus placebo [71]. The patients in the treatment group had higher FEV1 results at the end of the month of active treatment than placebo.…”

Section: The Role Of Systemic Antibioticsmentioning

confidence: 99%

Treatment of Pseudomonas and Staphylococcus Bronchopulmonary Infection in Patients with Cystic Fibrosis

Das

Kabra

Singh

2013

The Scientific World Journal

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The optimal antibiotic regimen is unclear in management of pulmonary infections due to pseudomonas and staphylococcus in cystic fibrosis (CF). We systematically searched all the published literature that has considered the evidence for antimicrobial therapies in CF till June 2013. The key findings were as follows: inhaled antipseudomonal antibiotic improves lung function, and probably the safest/most effective therapy; antistaphylococcal antibiotic prophylaxis increases the risk of acquiring P. aeruginosa; azithromycin significantly improves respiratory function after 6 months of treatment; a 28-day treatment with aztreonam or tobramycin significantly improves respiratory symptoms and pulmonary function; aztreonam lysine might be superior to tobramycin inhaled solution in chronic P. aeruginosa infection; oral ciprofloxacin does not produce additional benefit in those with chronic persistent pseudomonas infection but may have a role in early or first infection. As it is difficult to establish a firm recommendation based on the available evidence, the following factors must be considered for the choice of treatment for each patient: antibiotic related (e.g., safety and efficacy and ease of administration/delivery) and patient related (e.g., age, clinical status, prior use of antibiotics, coinfection by other organisms, and associated comorbidities ones).

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A controlled trial of nebulized aminoglycoside and oral flucloxacillin versus placebo in the outpatient management of children with cystic fibrosis

Cited by 60 publications

References 3 publications

Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics

Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics

Cystic fibrosis, pathophysiological and clinical aspects

Treatment of Pseudomonas and Staphylococcus Bronchopulmonary Infection in Patients with Cystic Fibrosis

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