P121 Short-term effect of physiotherapy on Lung Clearance Index among patients with cystic fibrosis (original) (raw)
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Respiratory Research, 2010
Background: Cystic Fibrosis (CF) is a life-shortening genetic disease in which~80% of deaths result from loss of lung function linked to inflammation due to chronic bacterial infection (principally Pseudomonas aeruginosa). Pulmonary exacerbations (intermittent episodes during which symptoms of lung infection increase and lung function decreases) can cause substantial resource utilization, morbidity, and irreversible loss of lung function. Intravenous antibiotic treatment to reduce exacerbation symptoms is standard management practice. However, no prospective studies have identified an optimal antibiotic treatment duration and this lack of objective data has been identified as an area of concern and interest.
Use of lung clearance index to assess the response to intravenous treatment in cystic fibrosis
Hippokratia
Progressive lung disease is the main cause of clinical deterioration and mortality in cystic fibrosis (CF) patients. Being able to assess the effectiveness of interventions is very significant. To assess the response to intravenous (IV) treatment among CF patients, using forced expired volume in 1(st) second (FEV1) and Lung Clearance Index (LCI) as outcome measures and to compare the effect of IV treatment on lung function and LCI between CF children being treated on a regular basis, or in case of a pulmonary exacerbation. Thirty-two CF patients (15 males) with mean age 9.90 (range: 2-23) years, performed spirometry and multiple breath washout (MBW) before and one month after IV antibiotic treatment. Nineteen patients received a course of elective treatment (group A) and 13 received IV antibiotic regimens for an acute exacerbation (group B). Statistically significant differences after treatment were seen in LCI (p≤0.001), and Forced Expiratory Flow (FEF) z-scores (p<0.05). FEV1 d...
American Journal of Respiratory and Critical Care Medicine, 2021
Rationale: People with cystic fibrosis (CF) experience acute worsening of respiratory symptoms and lung function known as pulmonary exacerbations. Treatment with intravenous antimicrobials is common; however, there is scant evidence to support a standard treatment duration. Objectives: To test differing durations of intravenous antimicrobials for CF exacerbations. Methods: STOP2 (Standardized Treatment of Pulmonary Exacerbations 2) was a multicenter, randomized, controlled clinical trial in exacerbations among adults with CF. After 7-10 days of treatment, participants exhibiting predefined lung function and symptom improvements were randomized to 10 or 14 days' total antimicrobial duration; all others were randomized to 14 or 21 days' duration. Measurements and Main Results: The primary outcome was percent predicted FEV 1 (ppFEV 1) change from treatment initiation to 2 weeks after cessation. Among early responders, noninferiority of 10 days to 14 days was tested; superiority of 21 days compared with 14 days was compared for the others. Symptoms, weight, and adverse events were secondary. Among 982 randomized people, 277 met improvement criteria and were randomized to 10 or 14 days of treatment; the remaining 705 received 21 or 14 days of treatment. Mean ppFEV 1 change was 12.8 and 13.4 for 10 and 14 days, respectively, a-0.65 difference (95% CI [-3.3 to 2.0]), excluding the predefined noninferiority margin. The 21-and 14-day arms experienced 3.3 and 3.4 mean ppFEV 1 changes, a difference of-0.10 (-1.3 to 1.1). Secondary endpoints and sensitivity analyses were supportive. Conclusions: Among adults with CF with early treatment improvement during exacerbation, ppFEV 1 after 10 days of intravenous antimicrobials is not inferior to 14 days. For those with less improvement after one week, 21 days is not superior to 14 days. Clinical trial registered with www.clinicaltrials.gov (NCT02781610).
American Journal of Respiratory and Critical Care Medicine, 2012
Rationale: Fosfomycin/tobramycin for inhalation (FTI), a unique, broad-spectrum antibiotic combination, may have therapeutic potential for patients with cystic fibrosis (CF). Objectives: To evaluate safety and efficacy of FTI (160/40 mg or 80/20 mg), administered twice daily for 28 days versus placebo, in patients greater than or equal to 18 years of age, with CF, chronic Pseudomonas aeruginosa (PA) airway infection, and FEV 1 greater than or equal to 25% and less than or equal to 75% predicted. Methods: This double-blind, placebo-controlled, multicenter study assessed whether FTI/placebo maintained FEV 1 % predicted improvements achieved following a 28-day, open-label, run-in course of aztreonam for inhalation solution (AZLI). Measurements and Main Results: A total of 119 patients were randomized to FTI (160/40 mg: n ¼ 41; 80/20 mg: n ¼ 38) or placebo (n ¼ 40). Mean age was 32 years and mean FEV 1 was 49% predicted at screening. Relative improvements in FEV 1 % predicted achieved by the AZLI run-in were maintained in FTI groups compared with placebo (160/ 40 mg vs. placebo: 6.2% treatment difference favoring FTI, P ¼ 0.002 [primary endpoint]; 80/20 mg vs. placebo: 7.5% treatment difference favoring FTI, P , 0.001). The treatment effect on mean PA sputum density was statistically significant for the FTI 80/20 mg group versus placebo (21.04 log 10 PA colony-forming units/g sputum difference, favoring FTI; P ¼ 0.01). Adverse events, primarily cough, were consistent with CF disease. Respiratory events, including dyspnea and wheezing, were less common with FTI 80/20 mg than FTI 160/40 mg. No clinically significant differences between groups were reported for laboratory values. Conclusions: FTI maintained the substantial improvements in FEV 1 % predicted achieved during the AZLI run-in and was well tolerated. FTI is a promising antipseudomonal therapy for patients with CF.
Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis
Pediatric Pulmonology, 2010
RationaleAirway secretion clearance therapies are a cornerstone of cystic fibrosis care, however longitudinal comparative studies are rare. Our objectives were to compare three therapies [postural drainage and percussion: (postural drainage), flutter device (FD), and high frequency chest wall oscillation: (vest)], by studying (1) change in pulmonary function; (2) time to need for intravenous (IV) antibiotics, (3) use of pulmonary therapies, (4) adherence to treatment, (5) treatment satisfaction, and (6) quality of life.Airway secretion clearance therapies are a cornerstone of cystic fibrosis care, however longitudinal comparative studies are rare. Our objectives were to compare three therapies [postural drainage and percussion: (postural drainage), flutter device (FD), and high frequency chest wall oscillation: (vest)], by studying (1) change in pulmonary function; (2) time to need for intravenous (IV) antibiotics, (3) use of pulmonary therapies, (4) adherence to treatment, (5) treatment satisfaction, and (6) quality of life.MethodsParticipants were randomly assigned to one of three therapies twice daily. Clinical outcomes were assessed quarterly over 3 years.Participants were randomly assigned to one of three therapies twice daily. Clinical outcomes were assessed quarterly over 3 years.ResultsEnrollment goals were not met, and withdrawal rates were high, especially in postural drainage (51%) and FD (26%), compared to vest (9%), resulting in early termination. FEV1 decline, time to need IV antibiotics, and other pulmonary therapies were not different. The annual FEF25–75% predicted rate of decline was greater in those using vest (P = 0.02). Adherence was not significantly different (P = 0.09). Overall treatment satisfaction was higher in vest and FD than in postural drainage (P < 0.05). Health-related quality of life was not different. The rate of FEV1 decline was 1.23% predicted/year.Enrollment goals were not met, and withdrawal rates were high, especially in postural drainage (51%) and FD (26%), compared to vest (9%), resulting in early termination. FEV1 decline, time to need IV antibiotics, and other pulmonary therapies were not different. The annual FEF25–75% predicted rate of decline was greater in those using vest (P = 0.02). Adherence was not significantly different (P = 0.09). Overall treatment satisfaction was higher in vest and FD than in postural drainage (P < 0.05). Health-related quality of life was not different. The rate of FEV1 decline was 1.23% predicted/year.ConclusionsThe study was ended early due to dropout and smaller than expected decline in FEV1. Patients were more satisfied with vest and FD. The longitudinal decline in FEF25–75% was faster in vest; we found no other difference in lung function decline, taken together this warrants further study. The slow decline in FEV1 illustrates the difficulty with FEV1 decline as a clinical trial outcome. Pediatr Pulmonol. 2010; 45:291–300. © 2010 Wiley-Liss, Inc.The study was ended early due to dropout and smaller than expected decline in FEV1. Patients were more satisfied with vest and FD. The longitudinal decline in FEF25–75% was faster in vest; we found no other difference in lung function decline, taken together this warrants further study. The slow decline in FEV1 illustrates the difficulty with FEV1 decline as a clinical trial outcome. Pediatr Pulmonol. 2010; 45:291–300. © 2010 Wiley-Liss, Inc.
CHEST Journal, 2009
Pseudomonas aeruginosa airway infection. At study enrollment, patients in the study 1-exacerbation had symptoms indicative of pulmonary exacerbation (n ؍ 84; < 14 years of age, 31 patients; > 14 years of age, 53 patients); patients in study 2-stable had stable respiratory symptoms (n ؍ 140; < 14 years of age, 14 patients; > 14 years, 126 patients). Methods: The anchor-based method utilized a global rating-of-change questionnaire (GRCQ) that assessed patients' perceptions of change in their respiratory symptoms after TIS treatment. The mean change from baseline CFQ-R-Respiratory scores were mapped onto the GRCQ to estimate the MCID. The two distribution-based methods were as follows: (1) 0.5 SD of mean change in CFQ-R-Respiratory scores (baseline to end of TIS treatment); and (2) 1 SEM for baseline CFQ-R-Respiratory scores. Triangulation of these three estimates defined the MCIDs. Results: MCID scores were larger for patients in study 1-exacerbation (8.5 points) than for those in study 2-stable (4.0 points), likely reflecting differences in patient disease status (exacerbation/ stable) between these studies.
American Journal of Respiratory and Critical Care Medicine, 2010
Rationale: Individuals with cystic fibrosis (CF) are subject to recurrent respiratory infections (exacerbations) that often require intravenous antibiotic treatment and may result in permanent loss of lung function. The optimal means of delivering therapy remains unclear. Objectives: To determine whether duration or venue of intravenous antibiotic administration affect lung function. Methods: Data were retrospectively collected on 1,535 subjects recruited by the US CF Twin and Sibling Study from US CF care centers between 2000 and 2007.
Background: Multiple Breath washout (MBW) represents an important tool to detect early a possible pulmonary exacerbation especially in Cystic Fibrosis (CF) disease. Lung clearance index (LCI) is the most commonly reported multiple breath washout (MBW) index and in the last years was used as management measure for evaluation. Our aim was to analyze clinical utility of LCI index variability in pulmonary exacerbation in CF. Methods: A single-center study was conducted at CF Unit of Bambino Gesù Children’s Hospital among hospitalized > 3 years patients for pulmonary exacerbations and treated with antibiotic intravenous treatment for 14 days. MBW and spirometry were evaluated within 72 hours of admission to hospital and at the end of hospitalization. Descriptive analysis was conducted and correlations between quantitative variables were investigated. Results: Fifty-seven patients (M22/F35) with an average age 18.56 (± 8.54) years were enrolled. LCI 2.5 was significantly reduced at the...
a v a i l a b l e a t w w w . s c i e n c e d i r e c t . c o m j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / r m e d Applying clinical outcome variables to appropriate aerosolized antibiotics for the treatment of patients with cystic fibrosis Summary Commercial availability of more than one inhaled antibiotic for the management of chronic Pseudomonas aeruginosa lung infections in persons with cystic fibrosis creates a welcome question: Can different inhaled therapies be combined to improve patient outcomes? Although clinicians intuit that antibiotic alternation might extend the duration of benefit, prospective clinical trials will be unable to test this hypothesis. Rather, endpoints acceptable for demonstrating the efficacy of a chronic pulmonary therapy (lung function improvement/stabilization, reduction in exacerbation risk, improvement in quality of life) can test only whether the benefit amplitude is increased during fixed treatment periods. Reduction in pulmonary exacerbation risk appears to be best suited for this task, although lack of consensus on an objective definition of exacerbation independent of the decision to treat is a shortcoming. The broader clinical question of whether a patient has become refractory to a chronic therapy over time would be better addressed with a carefully conducted withdrawal study.