Effectiveness of erdosteine in elderly patients with bronchiectasis and hypersecretion: a 15-day, prospective, parallel, open-label, pilot study.

BACKGROUND: Mucus plugging and hypersecretion have been associated with an increased relative risk of death in patients with bronchiectasis who may or may not have chronic obstructive pulmonary disease (COPD), which is of prognostic relevance in the elderly. However, chest physiotherapy and/or the use of mucoactive agents is considered to be an effective therapeutic model in treating patients with COPD and bronchiectasis. OBJECTIVE: The objective of this study was to test the effectiveness of oral erdosteine in treating elderly patients with bronchiectasis and chronic mucus hypersecretion who have been referred to a pulmonary rehabilitation program. METHODS: In this 15-day, prospective, parallel, open label, pilot study, elderly patients with bronchiectasis, hypersecretion, a noncurrent smoking status, who had been consecutively enrolled at Ospedale Villa Pineta's Pulmonary Rehabilitation Center, Pavullo-Modena, Italy, were randomized into 2 treatment groups. Group 1 consisted of those patients receiving PO erdosteine 225 mg BID and chest physiotherapy; group 2 comprised those patients receiving chest physiotherapy alone. Forced lung volumes, arterial blood gases, respiratory muscle strength, walking capacity (as measured by 6-minute walking test [6MWT]), and visual analog scale (VAS) symptoms (cough and dyspnea) were recorded at enrollment and at the conclusion of the study. Mucus density (MD), mucus purulence (MP), and mucus volume produced (MVP) were assessed using a 3-point scale (0 = best or low; 1 = moderate; and 2 = worst or high) at baseline and at 5-day time points during the study period. All measurements were assessed by personnel blinded and not directly associated with the study administration. RESULTS: Thirty patients (21 [70%] male and 9 [30%] female; mean [SD] age, 71 [11] years; and mean [SD] weight, 66 [3] kg) were enrolled. Characteristics were similar in the 2 groups at baseline. At day 15, significant improvements were observed in 6MWT, VAS cough, and VAS dyspnea (P < 0.01) in both groups. However, a significant improvement in forced expiratory volume in 1 second and forced vital capacity (in milliliters) was observed only in group i (0.2 [0.3]; P < 0.05). At day 15, improvement was observed in mean (SD) in MD, MP, and MVP scores for both groups. Significant changes, however, were observed in all 3 measurements in group 1 (-0.80 [0.22], -0.71 [0.51], and 1.01 [0.39], respectively), whereas a significant improvement was observed only in MD (-0.55 [0.44]) and MVP (0.45 [0.62]) in group 2. The improvement in MVP observed in group 1 was significantly better than that observed in group 2 (P < 0.05). CONCLUSION: This pilot study found that a regimen of PO erdosteine 225 mg BID in addition to routine chest physiotherapy provided some physiologic and clinical benefits in the treatment of these elderly patients with bronchiectasis and chronic mucus hyper-secretion.

Length and clinical effectiveness of pulmonary rehabilitation in outpatients with chronic airway obstruction.

STUDY OBJECTIVE: To assess the clinical effectiveness of pulmonary rehabilitation (PR) after 10 or 20 consecutive sessions in outpatients with chronic airway obstruction (CAO). DESIGN: Observational prospective cohort trial. SETTING: Outpatient clinic of a rehabilitation center. PATIENTS AND INTERVENTIONS: Twenty-five outpatients (mean age, 65 +/- 9 years [+/- SD]; FEV1, 64 +/- 12% predicted) admitted to a comprehensive PR program, including exercise training. MEASUREMENTS AND RESULTS: The load reached on a cycloergometer (maximal achieved load [W-max]), the maximal and isoload dyspnea and leg fatigue on a Borg scale, 6-min walk distance (6MWD), and the health-related quality of life as assessed using the St. George's Respiratory Questionnaire (SGRQ) [total and components score] have been recorded as outcome measures at baseline, after 10 sessions (T10), and after 20 sessions (T20). The predefined criteria of the clinically significant improvement were as follows: + 15% W-max, + 54 m at 6MWD, - 1 point at isoload dyspnea and leg fatigue, and - 4% at SGRQ scores. There was a mean significant difference between changes at T20 and T10 for 6MWD (- 42.96 m; 95% confidence interval [CI], - 57.79 to - 28.12 m; p = 0.001), total SGRQ (4.80; 95% CI, 2.29 to 7.31; p = 0.001), activity SGRQ (3.60; 95% CI, 0.48 to 6.71; p = 0.025), and symptoms SGRQ (5.96; 95% CI, 2.72 to 9.2; p = 0.001). The percentage of patients who improved was different at T20 as compared with T10 for W-max (68% and 48%, respectively; p = 0.025), 6MWD (76% and 20%, p = 0.001), and total SGRQ (64% and 36%, p = 0.008). CONCLUSIONS: A 10-session course of PR provides only limited clinically significant changes of outcome measures when compared with a 20-session course in outpatients with CAO of mild-to-moderate severity.