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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

Study design. V1–V9 Study Visit 1 to 9. V1 and V2 were scheduled 4 and 3 weeks prior to randomisation. HH, HandiHaler.
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fig1: Study design. V1–V9 Study Visit 1 to 9. V1 and V2 were scheduled 4 and 3 weeks prior to randomisation. HH, HandiHaler.

Mentions: The study design (Figure 1) and methods have been reported previously.17 This 24-week randomised parallel-group double-blind placebo-controlled multicentre trial of patients with GOLD stage II COPD previously naive to maintenance therapy was conducted at 70 centres in 10 countries (ClinicalTrials.gov identifier NCT00523991; study number 205.365).


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)

Study design. V1–V9 Study Visit 1 to 9. V1 and V2 were scheduled 4 and 3 weeks prior to randomisation. HH, HandiHaler.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig1: Study design. V1–V9 Study Visit 1 to 9. V1 and V2 were scheduled 4 and 3 weeks prior to randomisation. HH, HandiHaler.
Mentions: The study design (Figure 1) and methods have been reported previously.17 This 24-week randomised parallel-group double-blind placebo-controlled multicentre trial of patients with GOLD stage II COPD previously naive to maintenance therapy was conducted at 70 centres in 10 countries (ClinicalTrials.gov identifier NCT00523991; study number 205.365).

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