110 Head-to-head comparison of two inhaled tobramycin solutions in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) infection

Mazurek, Henryk; Lenoir, G.; Pelikan, L; Geidel, C.; Bolbás, Katalin; Antipkin, Y.; Blanco, Michael; Varoli, Guido; Gandini, G; Cicirello, Helen; Чучалин, А. Г.

doi:10.1016/s1569-1993(11)60127-6

Cited by 4 publications

(3 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A larger lung function response was also noted in subjects aged 6 -17 years than in adults in a study that compared 2 formulations of tobramycin solution for nebulization (Bramitob and TOBI). 24 Similarly, in a study investigating FEV 1 decline with dornase alfa, a statistically significant improvement occurred in children ages 8 -17 years old, but not in adults, 25 and a 4-year trial of high-dose ibuprofen 19 found that children under 13 years benefitted more than older subjects. In addition, in the AIR CF-1 study, subjects Ͻ 18 years had greater improvements in the CF Questionnaire-Revised respiratory symptom score following 4 weeks of treatment with aztreonam lysine for inhalation versus placebo than adults (Ͼ 20 points vs 6 points, respectively).…”

Section: Discussionmentioning

confidence: 97%

Tobramycin Inhalation Powder in Cystic Fibrosis Patients: Response by Age Group

et al. 2013

View full text Add to dashboard Cite

BACKGROUND: Tobramycin powder for inhalation (TIP) is a drug-device combination designed to reduce treatment time and improve ease of use compared with tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients. However, the ability of patients to use dry powder inhalers, and the efficacy of the treatments, may vary by age. METHODS: The "Establish a New Gold Standard for Efficacy and Safety With Tobramycin in Cystic Fibrosis" (EAGER) trial was a randomized, 24-week, multicenter, open-label, parallel-group study designed to evaluate the safety of TIP versus TIS in 553 subjects, ages > 6 years, with CF and P. aeruginosa infection. The main efficacy end point was percent-of-predicted FEV 1 at week 20 (end of third cycle of treatment). A post hoc analysis was undertaken in 517 subjects who took > 1 dose of study medication, to evaluate the relative efficacy and safety of TIP and TIS by age group: > 6 to < 13 y (children, n ‫؍‬ 46); > 13 to < 20 y (adolescents, n ‫؍‬ 114); and > 20 y (adults, n ‫؍‬ 357). RESULTS: Improvements in percent-of-predicted FEV 1 from baseline to end of cycle 3 were greatest in the children for both TIP and TIS. The treatment differences (TIP ؊ TIS) were 4.7% (85% CI ؊1.2 to 10.6), 3.7% (85% CI ؊0.1 to 7.5), and ؊0.8% (85% CI ؊3.1 to 1.5) in children, adolescents, and adults, respectively. Sputum P. aeruginosa density decreased from baseline with both treatments, with comparable treatment differences across the age groups after 3 cycles: children ؊0.93 (85% CI ؊2.4 to 0.5), adolescents ؊0.17 (85% CI ؊1.2 to 0.8), and adults ؊0.89 (85% CI ؊1.3 to ؊0.4). Overall, subject satisfaction scores were greater in all subjects with TIP, irrespective of age group. With the exception of cough and dysphonia, the safety profile of TIP was comparable to TIS, irrespective of age. CONCLUSIONS: TIP is comparable to TIS in efficacy outcomes and safety profile but had greater patient satisfaction in all the age groups.

show abstract

Section: Discussionmentioning

confidence: 97%

Tobramycin Inhalation Powder in Cystic Fibrosis Patients: Response by Age Group

et al. 2013

View full text Add to dashboard Cite

show abstract

“…Two clinical trials performed with TIS 300 mg/4 mL in chronically infected CF patients also revealed that treatment produced a significant improvement in forced expiratory volume in 1 second (FEV 1 ). 26 , 27 Mazurek et al 28 , 33 compared TIS 300 mg/5 mL with TIS 300 mg/4 mL in 321 patients and found improved FEV 1 in both arms.…”

Section: Administration Of Inhaled Tobramycinmentioning

confidence: 99%

Long-term safety and efficacy of tobramycin in the management of cystic fibrosis

Vázquez-Espinosa

Girón

Gómez-Punter

et al. 2015

TCRM

View full text Add to dashboard Cite

Cystic fibrosis (CF) is a fatal inherited disease caused by mutations in the CF transmembrane conductance regulator (CFTR) gene whose mortality is conditioned by a progressive decline in lung function. Bacterial infections play a key role in this decline. Chronic bacterial infection in CF patients varies over time and the presence of Pseudomonas aeruginosa in sputum is a marker of poor prognosis. P. aeruginosa is eradicated from the airways using inhaled antibiotics administered in various formulations and devices. Antipseudomonal antibiotics have extended the survival of CF patients to 40 years. Tobramycin is a bactericidal aminoglycoside antibiotic with demonstrated activity against gram-negative microorganisms. Initially, the drug was administered as an inhaled parenteral solution. Subsequently, a specific tobramycin inhalation solution was developed. PulmoSphere™ technology enables dry tobramycin powder to be formulated for inhalation (tobramycin inhalation powder) using a small and portable capsule-based breath-activated device (T-326). Chronic colonization by P. aeruginosa is the main indication for aerosol antibiotic therapy. The American Cystic Fibrosis Foundation, European guidelines, and Spanish consensus guidelines provide different recommendations for eradication.

show abstract

“…Therefore, new nebuliser systems have been investigated to improve tobramycin aerosol delivery to the peripheral airways and minimize residual drug wastage. Many in-vitro and in-vivo studies have been investigated to achieve these purposes [14][15][16][17][18][19][20][21][22][23][24][25][26][27] In-vivo studies the pharmacokinetic (PK) methods can provide accurate and reproducible quantification of drug delivery by measuring plasma levels to reflect lung deposition and bioavailability [28,29]. PK technique has been difficult to apply to most inhaled drugs, as the doses delivered are generally too small (microgram quantities), and the resulting plasma levels are low, which may be below the accurate detection limits of standard assays.…”

Section: Introductionmentioning

confidence: 99%

Assessment of recent nebulizer delivery systems using urinary pharmacokinetics method and aerodynamic characteristics of TOBI ® nebulized dose following inhalation

Mashat¹,

Clark

Assi

et al. 2017

Journal of Drug Delivery Science and Technology

View full text Add to dashboard Cite

show abstract

110 Head-to-head comparison of two inhaled tobramycin solutions in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) infection

Cited by 4 publications

References 0 publications

Tobramycin Inhalation Powder in Cystic Fibrosis Patients: Response by Age Group

Tobramycin Inhalation Powder in Cystic Fibrosis Patients: Response by Age Group

Long-term safety and efficacy of tobramycin in the management of cystic fibrosis

Assessment of recent nebulizer delivery systems using urinary pharmacokinetics method and aerodynamic characteristics of TOBI ® nebulized dose following inhalation

Contact Info

Product

Resources

About

110 Head-to-head comparison of two inhaled tobramycin solutions in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) infection

Cited by 4 publications

References 0 publications

Tobramycin Inhalation Powder in Cystic Fibrosis Patients: Response by Age Group

Tobramycin Inhalation Powder in Cystic Fibrosis Patients: Response by Age Group

Long-term safety and efficacy of tobramycin in the&nbsp;management of cystic fibrosis

Assessment of recent nebulizer delivery systems using urinary pharmacokinetics method and aerodynamic characteristics of TOBI ® nebulized dose following inhalation

Contact Info

Product

Resources

About

Long-term safety and efficacy of tobramycin in the management of cystic fibrosis