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Ease of use of tobramycin inhalation powder compared with nebulized tobramycin and colistimethate sodium: a crossover study in cystic fibrosis patients with pulmonary Pseudomonas aeruginosa infection.
Ther Adv Respir Dis. 2017 07; 11(7):249-260.TA

Abstract

BACKGROUND

This study assessed the ease of use of tobramycin inhalation powder (TIP) administered via T-326 inhaler versus tobramycin inhalation solution (TIS) and colistimethate sodium (COLI), both administered via nebulizers, for the treatment of chronic pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF).

METHODS

A real-world, open-label, crossover, interventional phase IV study was conducted in CF patients aged ⩾6 years with forced expiratory volume in 1 second (FEV1) ⩾25% to ⩽90% predicted. Patients were assigned to one of the three treatment arms in Cycle 1; all patients received TIP in Cycle 2. Each cycle consisted of 28 days on and 28 days off the treatment.

RESULTS

A total of 60 patients [mean (standard deviation) age, 27.6 (8.4) years] were allocated to three treatment arms [TIS/TIP (n = 14); COLI/TIP (n = 28); TIP/TIP (n = 18)] in Cycle 1. The mean total administration time, which included device setup and cleaning, in Cycle 1 versus Cycle 2 for TIS/TIP, COLI/TIP, and TIP/TIP arms were 37.0 versus 5.0 min, 16.4 versus 3.8 min, and 4.2 versus 3.4 min, respectively. The difference in mean total administration time was significantly shorter in Cycle 2 than in Cycle 1 for TIS/TIP (p = 0.0112) and COLI/TIP (p = 0.0016) arms. Overall, 12 patients were found to have contaminated devices across the two treatment cycles. In the TIP/TIP arm, no contamination of the T-326 inhaler was observed in either cycle. Treatment satisfaction, assessed by the Treatment Satisfaction Questionnaire for Medication and ACCEPT® questionnaire, was better overall for TIP compared with TIS and COLI. There were no unexpected adverse events and most were mild or moderate in intensity.

CONCLUSION

The T-326 inhaler used to deliver TIP was easy to use, required shorter total administration time, and was much less frequently contaminated than the nebulizers. The safety findings observed for TIP were generally consistent with its established safety profile.

Authors+Show Affiliations

Liverpool Heart and Chest Hospital NHS Foundation Trust, Thomas Drive, Liverpool, UK.Department of Pediatric Pneumology and Immunology, Cystic Fibrosis Centre Berlin, Charité-University Medicine Berlin, Berlin, Germany.Department of Pneumology, Ruhrlandklinik, West German Lung Center, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.West Midlands Adult Cystic Fibrosis Centre, Heart of England NHS Foundation Trust, Birmingham, UK.Clinic of Pneumology and Respiratory Cell Research, University Hospital, Basel, Switzerland.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1080, USA.

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

28614995

Citation

Greenwood, James, et al. "Ease of Use of Tobramycin Inhalation Powder Compared With Nebulized Tobramycin and Colistimethate Sodium: a Crossover Study in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa Infection." Therapeutic Advances in Respiratory Disease, vol. 11, no. 7, 2017, pp. 249-260.
Greenwood J, Schwarz C, Sommerwerck U, et al. Ease of use of tobramycin inhalation powder compared with nebulized tobramycin and colistimethate sodium: a crossover study in cystic fibrosis patients with pulmonary Pseudomonas aeruginosa infection. Ther Adv Respir Dis. 2017;11(7):249-260.
Greenwood, J., Schwarz, C., Sommerwerck, U., Nash, E. F., Tamm, M., Cao, W., Mastoridis, P., Debonnett, L., & Hamed, K. (2017). Ease of use of tobramycin inhalation powder compared with nebulized tobramycin and colistimethate sodium: a crossover study in cystic fibrosis patients with pulmonary Pseudomonas aeruginosa infection. Therapeutic Advances in Respiratory Disease, 11(7), 249-260. https://doi.org/10.1177/1753465817710596
Greenwood J, et al. Ease of Use of Tobramycin Inhalation Powder Compared With Nebulized Tobramycin and Colistimethate Sodium: a Crossover Study in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa Infection. Ther Adv Respir Dis. 2017;11(7):249-260. PubMed PMID: 28614995.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ease of use of tobramycin inhalation powder compared with nebulized tobramycin and colistimethate sodium: a crossover study in cystic fibrosis patients with pulmonary Pseudomonas aeruginosa infection. AU - Greenwood,James, AU - Schwarz,Carsten, AU - Sommerwerck,Urte, AU - Nash,Edward F, AU - Tamm,Michael, AU - Cao,Weihua, AU - Mastoridis,Paul, AU - Debonnett,Laurie, AU - Hamed,Kamal, PY - 2017/6/16/entrez PY - 2017/6/16/pubmed PY - 2018/4/3/medline KW - Pseudomonas aeruginosa KW - T-326 inhaler KW - device contamination KW - ease of use KW - nebulizer KW - tobramycin SP - 249 EP - 260 JF - Therapeutic advances in respiratory disease JO - Ther Adv Respir Dis VL - 11 IS - 7 N2 - BACKGROUND: This study assessed the ease of use of tobramycin inhalation powder (TIP) administered via T-326 inhaler versus tobramycin inhalation solution (TIS) and colistimethate sodium (COLI), both administered via nebulizers, for the treatment of chronic pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF). METHODS: A real-world, open-label, crossover, interventional phase IV study was conducted in CF patients aged ⩾6 years with forced expiratory volume in 1 second (FEV1) ⩾25% to ⩽90% predicted. Patients were assigned to one of the three treatment arms in Cycle 1; all patients received TIP in Cycle 2. Each cycle consisted of 28 days on and 28 days off the treatment. RESULTS: A total of 60 patients [mean (standard deviation) age, 27.6 (8.4) years] were allocated to three treatment arms [TIS/TIP (n = 14); COLI/TIP (n = 28); TIP/TIP (n = 18)] in Cycle 1. The mean total administration time, which included device setup and cleaning, in Cycle 1 versus Cycle 2 for TIS/TIP, COLI/TIP, and TIP/TIP arms were 37.0 versus 5.0 min, 16.4 versus 3.8 min, and 4.2 versus 3.4 min, respectively. The difference in mean total administration time was significantly shorter in Cycle 2 than in Cycle 1 for TIS/TIP (p = 0.0112) and COLI/TIP (p = 0.0016) arms. Overall, 12 patients were found to have contaminated devices across the two treatment cycles. In the TIP/TIP arm, no contamination of the T-326 inhaler was observed in either cycle. Treatment satisfaction, assessed by the Treatment Satisfaction Questionnaire for Medication and ACCEPT® questionnaire, was better overall for TIP compared with TIS and COLI. There were no unexpected adverse events and most were mild or moderate in intensity. CONCLUSION: The T-326 inhaler used to deliver TIP was easy to use, required shorter total administration time, and was much less frequently contaminated than the nebulizers. The safety findings observed for TIP were generally consistent with its established safety profile. SN - 1753-4666 UR - https://www.unboundmedicine.com/medline/citation/28614995/Ease_of_use_of_tobramycin_inhalation_powder_compared_with_nebulized_tobramycin_and_colistimethate_sodium:_a_crossover_study_in_cystic_fibrosis_patients_with_pulmonary_Pseudomonas_aeruginosa_infection_ L2 - https://journals.sagepub.com/doi/10.1177/1753465817710596?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -