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Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial.

Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C - NPJ Prim Care Respir Med (2014)

Bottom Line: Physician's Global Assessment (health status) improved (P=0.045) with less impairment on the Work Productivity and Activity Impairment questionnaire (P=0.043) at week 24.The incidence of exacerbations, cough, bronchitis and dyspnoea was lower with tiotropium than placebo.Tiotropium improved lung function and patient-reported outcomes in maintenance therapy-naive patients with GOLD stage II COPD, suggesting benefits in initiating maintenance therapy early.

View Article: PubMed Central - PubMed

Affiliation: Department of Rehabilitation Sciences and Respiratory Division UZ Leuven, Katholieke Universiteit Leuven, Leuven, Belgium.

ABSTRACT

Background: The benefits of pharmacotherapy with tiotropium HandiHaler 18 μg for patients with chronic obstructive pulmonary disease (COPD) have been previously demonstrated. However, few data exist regarding the treatment of moderate disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II).

Aims: To determine whether tiotropium improves lung function/patient-reported outcomes in patients with GOLD stage II COPD naive to maintenance therapy.

Methods: A randomised 24-week double-blind placebo-controlled trial of tiotropium 18 μg once daily (via HandiHaler) was performed in maintenance therapy-naive patients with forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio <0.7 and post-bronchodilator FEV1 ≥50 and <80%.

Results: A total of 457 patients were randomised (238 tiotropium, 219 placebo; mean age 62 years; FEV1 1.93 l (66% predicted)). Tiotropium was superior to placebo in mean change from baseline in post-dose FEV1 area under the curve from 0 to 3 h (AUC0-3h) at week 24 (primary endpoint): 0.19 vs. -0.03 l (least-squares mean difference 0.23 l, P<0.001). FVC AUC0-3h, trough and peak FEV1 and FVC were significantly improved with tiotropium versus placebo (P<0.001). Compared with placebo, tiotropium provided numerical improvements in physical activity (P=NS). Physician's Global Assessment (health status) improved (P=0.045) with less impairment on the Work Productivity and Activity Impairment questionnaire (P=0.043) at week 24. The incidence of exacerbations, cough, bronchitis and dyspnoea was lower with tiotropium than placebo.

Conclusions: Tiotropium improved lung function and patient-reported outcomes in maintenance therapy-naive patients with GOLD stage II COPD, suggesting benefits in initiating maintenance therapy early.

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Related in: MedlinePlus

Lung function outcomes (presented as means±s.e. (a) Pre-dose FEV1 (raw values in litres) at time −10 min and post-dose FEV1 at 30, 60, 90, 120, 150 and 180 min, by treatment group at baseline and last study visit; (b) FEV1 AUC0–3h; (c) FVC AUC0–3h; (d) trough FEV1; and (e) trough FVC by treatment group during the course of the study. AUC0–3h, area under the curve between 0 and 3 h; CI, confidence interval; FEV1, forced expiratory volume in 1s; FVC, forced vital capacity; LS, least squares.
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fig3: Lung function outcomes (presented as means±s.e. (a) Pre-dose FEV1 (raw values in litres) at time −10 min and post-dose FEV1 at 30, 60, 90, 120, 150 and 180 min, by treatment group at baseline and last study visit; (b) FEV1 AUC0–3h; (c) FVC AUC0–3h; (d) trough FEV1; and (e) trough FVC by treatment group during the course of the study. AUC0–3h, area under the curve between 0 and 3 h; CI, confidence interval; FEV1, forced expiratory volume in 1s; FVC, forced vital capacity; LS, least squares.

Mentions: Figure 3a shows the mean pre-dose FEV1 (raw values in litres) at time 0 and the mean post-dose FEV1 for up to 3 h post-dose in the tiotropium and placebo groups at baseline and the last visit (week 24). For the primary endpoint of mean change from baseline in FEV1 AUC0–3h at week 24, tiotropium was superior to placebo (0.19±0.27 vs. −0.03±0.22 l; least-squares (LS) mean difference 0.23 l; 95% CI, 0.18–0.27; P<0.001; Figure 3b. The corresponding mean change from baseline to week 24 values for FVC AUC0–3h were 0.23±0.47 l for tiotropium and −0.06±0.37 l for placebo (LS mean difference tiotropium versus placebo 0.31 l; 95% CI, 0.24–0.38; P<0.001; Figure 3c).


Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial.

Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C - NPJ Prim Care Respir Med (2014)

Lung function outcomes (presented as means±s.e. (a) Pre-dose FEV1 (raw values in litres) at time −10 min and post-dose FEV1 at 30, 60, 90, 120, 150 and 180 min, by treatment group at baseline and last study visit; (b) FEV1 AUC0–3h; (c) FVC AUC0–3h; (d) trough FEV1; and (e) trough FVC by treatment group during the course of the study. AUC0–3h, area under the curve between 0 and 3 h; CI, confidence interval; FEV1, forced expiratory volume in 1s; FVC, forced vital capacity; LS, least squares.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4373257&req=5

fig3: Lung function outcomes (presented as means±s.e. (a) Pre-dose FEV1 (raw values in litres) at time −10 min and post-dose FEV1 at 30, 60, 90, 120, 150 and 180 min, by treatment group at baseline and last study visit; (b) FEV1 AUC0–3h; (c) FVC AUC0–3h; (d) trough FEV1; and (e) trough FVC by treatment group during the course of the study. AUC0–3h, area under the curve between 0 and 3 h; CI, confidence interval; FEV1, forced expiratory volume in 1s; FVC, forced vital capacity; LS, least squares.
Mentions: Figure 3a shows the mean pre-dose FEV1 (raw values in litres) at time 0 and the mean post-dose FEV1 for up to 3 h post-dose in the tiotropium and placebo groups at baseline and the last visit (week 24). For the primary endpoint of mean change from baseline in FEV1 AUC0–3h at week 24, tiotropium was superior to placebo (0.19±0.27 vs. −0.03±0.22 l; least-squares (LS) mean difference 0.23 l; 95% CI, 0.18–0.27; P<0.001; Figure 3b. The corresponding mean change from baseline to week 24 values for FVC AUC0–3h were 0.23±0.47 l for tiotropium and −0.06±0.37 l for placebo (LS mean difference tiotropium versus placebo 0.31 l; 95% CI, 0.24–0.38; P<0.001; Figure 3c).

Bottom Line: Physician's Global Assessment (health status) improved (P=0.045) with less impairment on the Work Productivity and Activity Impairment questionnaire (P=0.043) at week 24.The incidence of exacerbations, cough, bronchitis and dyspnoea was lower with tiotropium than placebo.Tiotropium improved lung function and patient-reported outcomes in maintenance therapy-naive patients with GOLD stage II COPD, suggesting benefits in initiating maintenance therapy early.

View Article: PubMed Central - PubMed

Affiliation: Department of Rehabilitation Sciences and Respiratory Division UZ Leuven, Katholieke Universiteit Leuven, Leuven, Belgium.

ABSTRACT

Background: The benefits of pharmacotherapy with tiotropium HandiHaler 18 μg for patients with chronic obstructive pulmonary disease (COPD) have been previously demonstrated. However, few data exist regarding the treatment of moderate disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II).

Aims: To determine whether tiotropium improves lung function/patient-reported outcomes in patients with GOLD stage II COPD naive to maintenance therapy.

Methods: A randomised 24-week double-blind placebo-controlled trial of tiotropium 18 μg once daily (via HandiHaler) was performed in maintenance therapy-naive patients with forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio <0.7 and post-bronchodilator FEV1 ≥50 and <80%.

Results: A total of 457 patients were randomised (238 tiotropium, 219 placebo; mean age 62 years; FEV1 1.93 l (66% predicted)). Tiotropium was superior to placebo in mean change from baseline in post-dose FEV1 area under the curve from 0 to 3 h (AUC0-3h) at week 24 (primary endpoint): 0.19 vs. -0.03 l (least-squares mean difference 0.23 l, P<0.001). FVC AUC0-3h, trough and peak FEV1 and FVC were significantly improved with tiotropium versus placebo (P<0.001). Compared with placebo, tiotropium provided numerical improvements in physical activity (P=NS). Physician's Global Assessment (health status) improved (P=0.045) with less impairment on the Work Productivity and Activity Impairment questionnaire (P=0.043) at week 24. The incidence of exacerbations, cough, bronchitis and dyspnoea was lower with tiotropium than placebo.

Conclusions: Tiotropium improved lung function and patient-reported outcomes in maintenance therapy-naive patients with GOLD stage II COPD, suggesting benefits in initiating maintenance therapy early.

Show MeSH
Related in: MedlinePlus