Placebo-controlled, double-blind, randomized study of aerosolized tobramycin for early treatment ofPseudomonas aeruginosa colonization in cystic fibrosis

Wiesemann, H. G.; Steinkamp, Gratiana; Ratjen, Félix; Bauernfeind, A.; Przyklenk, B.; Döring, Gerd; Hardt, H. von der

doi:10.1002/(sici)1099-0496(199802)25:2<88::aid-ppul3>3.0.co;2-j

Cited by 181 publications

(20 citation statements)

References 26 publications

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“…Aminoglycosides are antipseudomonal antibiotics that have several characteristics that have lent themselves to use as inhaled CF therapies 31,32,36,43,44,46,48,49,53,56–58. These characteristics include good solubility, relative stability in aqueous solution, physicochemical properties conducive to aerosolization, systemic as opposed to local dose-limiting toxicities, and bacterial killing proportional to maximum drug concentration achieved at the infection site 59…”

Section: Topical Administration Of Tobramycin In Cfmentioning

confidence: 99%

Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review

VanDevanter

Geller²

2011

MDER

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From its introduction, the antibiotic tobramycin has been an important tool in the management of persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infections. Initially an intravenous rescue treatment for pulmonary exacerbations, tobramycin delivered by inhalation has become a mainstay of chronic suppressive CF infection management. Platforms for tobramycin aerosol delivery have steadily improved, with increased lung deposition complimented by decreased device complexities, loaded tobramycin doses, delivery times, and treatment burdens. Most recently, a unique tobramycin inhalation powder (TIP) formulation with a portable delivery system, the TOBI® Podhaler® (Novartis AG, Basel, Switzerland) has been developed and approved in Europe, Canada, and Chile. Four capsules, each containing 28 mg of TIP are successively pierced and inhaled via the T-326 Dry Powder Inhaler Device (Novartis AG, Basel, Switzerland). No external power source is required to deliver an efficacious tobramycin dose in minutes. By comparison, tobramycin inhalation solution (TIS) (TOBI®; Novartis), is delivered by LC® Plus (PARI Respiratory Equipment Inc, Midlothian, VA) jet nebulizer powered by an air compressor over 15–20 minutes. Comparative pharmacokinetics, safety, and efficacy studies of TIS and TIP in CF subjects with P. aeruginosa ≥ 6 years old demonstrate that: tobramycin lung deposition with 112 mg TIP is comparable to that attained with 300 mg TIS, TIP is more effective than placebo and not inferior to TIS with respect to pulmonary function benefit, and TIP has significantly faster treatment times and achieves higher patient satisfaction than TIS. TIP is associated with an increased frequency of mild to moderate local adverse events (cough, dysphonia, and dysgeusia) compared with TIS, however, these become less frequent as subjects gain TIP experience. These results suggest that the TOBI Podhaler may better meet the needs of many CF patients and families by reducing treatment time and complexity and improving patient satisfaction compared with TIS.

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Section: Topical Administration Of Tobramycin In Cfmentioning

confidence: 99%

Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review

VanDevanter

Geller²

2011

MDER

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“…From the 1980s, inhaled tobramycin was also increasingly used for treatment of chronic P. aeruginosa pulmonary infection, with well-proven benefits by the end of the 1990s,10,11 which led to the approval of tobramycin inhalation solution in chronic P. aeruginosa infection in CF by 2001. Tobramycin had been used for a long time before as intravenous solution and off-label for inhalation 9,12,13…”

Section: Introductionmentioning

confidence: 99%

Colistimethate sodium for the treatment of chronic pulmonary infection in cystic fibrosis: an evidence-based review of its place in therapy

Koerner-Rettberg¹,

Ballmann²

2014

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Chronic bacterial respiratory-tract infections are a major driving force in the pathogenesis of cystic fibrosis (CF) lung disease and promote chronic lung-function decline, destruction, and progression to respiratory failure at a premature age. Gram-negative bacteria colonizing the airways in CF are a major problem in CF therapy due to their tendency to develop a high degree of resistance to antibiotic agents over time. Pseudomonas aeruginosa is the dominating bacterial strain infecting the CF lung from early childhood on, and multiresistant strains frequently develop after years of therapy. Colistin has been used for treating pulmonary bacterial infections in CF for decades due to its very good Gram-negative activity. However, drawbacks include concerns regarding toxicity when being applied systemically, and the lack of approval for application by inhalation in the USA for many years. Other antibiotic substances for systemic use are available with good to excellent Gram-negative and anti-Pseudomonas activity, while there are only three substances approved for inhalation use in the treatment of chronic pulmonary infection with proven benefit in CF. The emergence of multiresistant strains leaving nearly no antibiotic substance as a treatment option, the limited number of antibiotics with high activity against P. aeruginosa, the concerns about increasing the risk of antibiotic resistance by continuous antibiotic therapy, the development of new drug formulations and drug-delivery devices, and, finally, the differing treatment strategies used in CF centers call for defining the place of this “old” drug, colistimethate, in today’s CF therapy. This article reviews the available evidence to reflect on the place of colistimethate sodium in the therapy of chronic pulmonary infection in CF.

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“…16, 21, 22 Although spontaneous clearance may occur in some patients, 18, 19 data suggest that antibiotics might be superior to no treatment. 23 Based upon these data, aggressive antibiotic treatment at initial Pa airway detection has been recommended using a range of antibiotic strategies and treatment duration.…”

mentioning

confidence: 99%

Comparative Efficacy and Safety of 4 Randomized Regimens to Treat EarlyPseudomonas aeruginosaInfection in Children With Cystic Fibrosis

Treggiari

Retsch‐Bogart²,

Mayer-Hamblett

et al. 2011

Arch Pediatr Adolesc Med

202

180

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Placebo-controlled, double-blind, randomized study of aerosolized tobramycin for early treatment ofPseudomonas aeruginosa colonization in cystic fibrosis

Cited by 181 publications

References 26 publications

Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review

Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review

Colistimethate sodium for the treatment of chronic pulmonary infection in cystic fibrosis: an evidence-based review of its place in therapy

Comparative Efficacy and Safety of 4 Randomized Regimens to Treat EarlyPseudomonas aeruginosaInfection in Children With Cystic Fibrosis

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Placebo-controlled, double-blind, randomized study of aerosolized tobramycin for early treatment ofPseudomonas aeruginosa colonization in cystic fibrosis

Cited by 181 publications

References 26 publications

Tobramycin administered by the TOBI&reg; Podhaler&reg; for persons with cystic fibrosis: a review

Tobramycin administered by the TOBI&reg; Podhaler&reg; for persons with cystic fibrosis: a review

Colistimethate sodium for the treatment of chronic pulmonary infection in cystic fibrosis: an evidence-based review of its place in therapy

Comparative Efficacy and Safety of 4 Randomized Regimens to Treat EarlyPseudomonas aeruginosaInfection in Children With Cystic Fibrosis

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Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review

Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review