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

Respir Med. 2018 May:138:88-94. doi: 10.1016/j.rmed.2018.03.034. Epub 2018 Mar 31.

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.

Keywords: CFQ-R; Compliance; Cystic fibrosis; ITA-CFq; Pseudomonas aeruginosa; Quality of life; TIP; TOBI podhaler; TSQM.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / therapeutic use
  • Chronic Disease
  • Cystic Fibrosis / complications*
  • Dry Powder Inhalers
  • Humans
  • Longitudinal Studies
  • Medication Adherence / statistics & numerical data*
  • Opportunistic Infections / complications
  • Opportunistic Infections / drug therapy*
  • Patient Satisfaction
  • Pseudomonas Infections / complications
  • Pseudomonas Infections / drug therapy*
  • Pseudomonas aeruginosa*
  • Quality of Life
  • Tobramycin / administration & dosage*
  • Tobramycin / therapeutic use
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Tobramycin