Treatment compliance in cystic fibrosis patients with chronic Pseudomonas aeruginosa infection treated with tobramycin inhalation powder: The FREE study

FREE study group

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: A high treatment burden with nebulised therapies in cystic fibrosis (CF) patients is the major limitation for treatment compliance; moreover, studies on treatment compliance with inhaled antibiotics are limited. This study assessed compliance to TOBI® Podhaler™ (TIP) treatment in CF patients with chronic Pseudomonas aeruginosa (Pa) infections in a real-world setting using the Italian Treatment Adherence CF Questionnaire (ITA-CFq). Methods: This longitudinal, multicentre, cohort study included 2 follow-up (FU) visits: FU-1 at 3-months±15-days from the baseline visit and FU-2 at the end of third TIP cycle (or 6-months after enrolment, whichever occurred first). The effect of TIP on quality-of-life (QoL) and treatment satisfaction were evaluated using Cystic Fibrosis Questionnaire-Revised (CFQ-R) and Treatment Satisfaction Questionnaire for Medication (TSQM), respectively. Overall compliance to treatments was assessed using ITA-CFq. Results: Eighty-two patients (mean age, 24.8 ± 7.9 years), including 22 paediatric patients (age, <18 years), were enrolled in the study; 56 (68.3%) patients, including 17 paediatric patients, completed the study. At baseline, the mean compliance score to aerosol antibiotic treatment was 7.8 ± 3.2; upon introducing TIP, the compliance score improved to 9.4 ± 1.2 at the FU-1 and thereafter remained stable at 9.5 ± 1.2. TSQM was higher for the convenience domain (74.2 ± 17.1 at enrolment and slightly improved to 77.8 ± 15.9 at FU-2) following TIP initiation. No substantial effect of TIP was observed on the QoL when measured using the revised CFQ-R. The safety profile was in line with previous findings. Conclusion: TIP was convenient to use and led to improved treatment adherence in CF patients with chronic Pa-infection.

Original languageEnglish
Pages (from-to)88-94
Number of pages7
JournalRespiratory Medicine
Volume138
DOIs
Publication statusPublished - May 1 2018

Fingerprint

Pseudomonas Infections
Tobramycin
Cystic Fibrosis
Powders
Pseudomonas aeruginosa
Inhalation
Therapeutics
Quality of Life
Pediatrics
Anti-Bacterial Agents
Aerosols
Compliance
Multicenter Studies
Cohort Studies

Keywords

  • CFQ-R
  • Compliance
  • Cystic fibrosis
  • ITA-CFq
  • Pseudomonas aeruginosa
  • Quality of life
  • TIP
  • TOBI podhaler
  • TSQM

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

@article{473055da9a4d422b91573461b3526f43,
title = "Treatment compliance in cystic fibrosis patients with chronic Pseudomonas aeruginosa infection treated with tobramycin inhalation powder: The FREE study",
abstract = "Background: A high treatment burden with nebulised therapies in cystic fibrosis (CF) patients is the major limitation for treatment compliance; moreover, studies on treatment compliance with inhaled antibiotics are limited. This study assessed compliance to TOBI{\circledR} Podhaler™ (TIP) treatment in CF patients with chronic Pseudomonas aeruginosa (Pa) infections in a real-world setting using the Italian Treatment Adherence CF Questionnaire (ITA-CFq). Methods: This longitudinal, multicentre, cohort study included 2 follow-up (FU) visits: FU-1 at 3-months±15-days from the baseline visit and FU-2 at the end of third TIP cycle (or 6-months after enrolment, whichever occurred first). The effect of TIP on quality-of-life (QoL) and treatment satisfaction were evaluated using Cystic Fibrosis Questionnaire-Revised (CFQ-R) and Treatment Satisfaction Questionnaire for Medication (TSQM), respectively. Overall compliance to treatments was assessed using ITA-CFq. Results: Eighty-two patients (mean age, 24.8 ± 7.9 years), including 22 paediatric patients (age, <18 years), were enrolled in the study; 56 (68.3{\%}) patients, including 17 paediatric patients, completed the study. At baseline, the mean compliance score to aerosol antibiotic treatment was 7.8 ± 3.2; upon introducing TIP, the compliance score improved to 9.4 ± 1.2 at the FU-1 and thereafter remained stable at 9.5 ± 1.2. TSQM was higher for the convenience domain (74.2 ± 17.1 at enrolment and slightly improved to 77.8 ± 15.9 at FU-2) following TIP initiation. No substantial effect of TIP was observed on the QoL when measured using the revised CFQ-R. The safety profile was in line with previous findings. Conclusion: TIP was convenient to use and led to improved treatment adherence in CF patients with chronic Pa-infection.",
keywords = "CFQ-R, Compliance, Cystic fibrosis, ITA-CFq, Pseudomonas aeruginosa, Quality of life, TIP, TOBI podhaler, TSQM",
author = "{FREE study group} and Francesco Blasi and Vincenzo Carnovale and Giuseppe Cimino and Vincenzina Lucidi and Donatello Salvatore and Barbara Messore and Marta Bartezaghi and Elisa Muscianisi and Porpiglia, {Pasquale Alberto}",
year = "2018",
month = "5",
day = "1",
doi = "10.1016/j.rmed.2018.03.034",
language = "English",
volume = "138",
pages = "88--94",
journal = "Respiratory Medicine",
issn = "0954-6111",
publisher = "W.B. Saunders Ltd",

}

TY - JOUR

T1 - Treatment compliance in cystic fibrosis patients with chronic Pseudomonas aeruginosa infection treated with tobramycin inhalation powder

T2 - The FREE study

AU - FREE study group

AU - Blasi, Francesco

AU - Carnovale, Vincenzo

AU - Cimino, Giuseppe

AU - Lucidi, Vincenzina

AU - Salvatore, Donatello

AU - Messore, Barbara

AU - Bartezaghi, Marta

AU - Muscianisi, Elisa

AU - Porpiglia, Pasquale Alberto

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Background: A high treatment burden with nebulised therapies in cystic fibrosis (CF) patients is the major limitation for treatment compliance; moreover, studies on treatment compliance with inhaled antibiotics are limited. This study assessed compliance to TOBI® Podhaler™ (TIP) treatment in CF patients with chronic Pseudomonas aeruginosa (Pa) infections in a real-world setting using the Italian Treatment Adherence CF Questionnaire (ITA-CFq). Methods: This longitudinal, multicentre, cohort study included 2 follow-up (FU) visits: FU-1 at 3-months±15-days from the baseline visit and FU-2 at the end of third TIP cycle (or 6-months after enrolment, whichever occurred first). The effect of TIP on quality-of-life (QoL) and treatment satisfaction were evaluated using Cystic Fibrosis Questionnaire-Revised (CFQ-R) and Treatment Satisfaction Questionnaire for Medication (TSQM), respectively. Overall compliance to treatments was assessed using ITA-CFq. Results: Eighty-two patients (mean age, 24.8 ± 7.9 years), including 22 paediatric patients (age, <18 years), were enrolled in the study; 56 (68.3%) patients, including 17 paediatric patients, completed the study. At baseline, the mean compliance score to aerosol antibiotic treatment was 7.8 ± 3.2; upon introducing TIP, the compliance score improved to 9.4 ± 1.2 at the FU-1 and thereafter remained stable at 9.5 ± 1.2. TSQM was higher for the convenience domain (74.2 ± 17.1 at enrolment and slightly improved to 77.8 ± 15.9 at FU-2) following TIP initiation. No substantial effect of TIP was observed on the QoL when measured using the revised CFQ-R. The safety profile was in line with previous findings. Conclusion: TIP was convenient to use and led to improved treatment adherence in CF patients with chronic Pa-infection.

AB - Background: A high treatment burden with nebulised therapies in cystic fibrosis (CF) patients is the major limitation for treatment compliance; moreover, studies on treatment compliance with inhaled antibiotics are limited. This study assessed compliance to TOBI® Podhaler™ (TIP) treatment in CF patients with chronic Pseudomonas aeruginosa (Pa) infections in a real-world setting using the Italian Treatment Adherence CF Questionnaire (ITA-CFq). Methods: This longitudinal, multicentre, cohort study included 2 follow-up (FU) visits: FU-1 at 3-months±15-days from the baseline visit and FU-2 at the end of third TIP cycle (or 6-months after enrolment, whichever occurred first). The effect of TIP on quality-of-life (QoL) and treatment satisfaction were evaluated using Cystic Fibrosis Questionnaire-Revised (CFQ-R) and Treatment Satisfaction Questionnaire for Medication (TSQM), respectively. Overall compliance to treatments was assessed using ITA-CFq. Results: Eighty-two patients (mean age, 24.8 ± 7.9 years), including 22 paediatric patients (age, <18 years), were enrolled in the study; 56 (68.3%) patients, including 17 paediatric patients, completed the study. At baseline, the mean compliance score to aerosol antibiotic treatment was 7.8 ± 3.2; upon introducing TIP, the compliance score improved to 9.4 ± 1.2 at the FU-1 and thereafter remained stable at 9.5 ± 1.2. TSQM was higher for the convenience domain (74.2 ± 17.1 at enrolment and slightly improved to 77.8 ± 15.9 at FU-2) following TIP initiation. No substantial effect of TIP was observed on the QoL when measured using the revised CFQ-R. The safety profile was in line with previous findings. Conclusion: TIP was convenient to use and led to improved treatment adherence in CF patients with chronic Pa-infection.

KW - CFQ-R

KW - Compliance

KW - Cystic fibrosis

KW - ITA-CFq

KW - Pseudomonas aeruginosa

KW - Quality of life

KW - TIP

KW - TOBI podhaler

KW - TSQM

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U2 - 10.1016/j.rmed.2018.03.034

DO - 10.1016/j.rmed.2018.03.034

M3 - Article

AN - SCOPUS:85044937590

VL - 138

SP - 88

EP - 94

JO - Respiratory Medicine

JF - Respiratory Medicine

SN - 0954-6111

ER -