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Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD.

Tonnel AB, Perez T, Grosbois JM, Verkindre C, Bravo ML, Brun M, TIPHON study gro - Int J Chron Obstruct Pulmon Dis (2008)

Bottom Line: Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score vs placebo at study end (59.1% vs 48.2%, respectively; p = 0.029).Tiotropium significantly improved spirometric parameters (forced expiratory volume in 1 second [FEV1]: 0.11 +/- 0.02 L vs 0.01 +/- 0.02 L; between-group difference: 0.10 +/- 0.03 L, p = 0.0001) and reduced exacerbations vs placebo.Maintenance treatment with tiotropium provided significant and clinically relevant improvements in HRQoL, as measured by the SGRQ.

View Article: PubMed Central - PubMed

Affiliation: Centre Hospitalier Régional Universitaire (CHRU) de Lille, Service de Pneumologie et Immuno-Allergologie, Lille Cedex, France. ab-tonnel@chru-lille.fr

ABSTRACT
Clinical manifestations of chronic obstructive pulmonary disease (COPD), including airflow limitation, dyspnea, and activity limitation, ultimately lead to impaired health-related quality of life (HRQoL). This 9-month, randomized, double-blind, multicenter study compared the effect of once-daily tiotropium 18 microg and placebo on HRQoL, spirometric parameters, and exacerbations in 554 patients with moderate-to-severe COPD. HRQoL was assessed using the St. George's Respiratory Questionnaire (SGRQ) and the new 8-item Visual Simplified Respiratory Questionnaire (VSRQ), which is currently being validated. The primary efficacy endpoint was the proportion of patients achieving a reduction of at least 4 units in the SGRQ total score at study end (Month 9). Mean +/- SD baseline SGRQ total score was 47.4 +/- 18.1. Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score vs placebo at study end (59.1% vs 48.2%, respectively; p = 0.029). Tiotropium significantly improved spirometric parameters (forced expiratory volume in 1 second [FEV1]: 0.11 +/- 0.02 L vs 0.01 +/- 0.02 L; between-group difference: 0.10 +/- 0.03 L, p = 0.0001) and reduced exacerbations vs placebo. Maintenance treatment with tiotropium provided significant and clinically relevant improvements in HRQoL, as measured by the SGRQ.

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Trial flow chart.
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f1-copd-3-301: Trial flow chart.

Mentions: A total of 555 patients were randomized and 554 received treatment, with 266 receiving tiotropium and 288 receiving placebo (Figure 1). Patients who dropped out but had baseline and post-treatment data were included in the full analysis dataset, following the intent-to-treat principle. 492 patients (tiotropium, n = 247; placebo, n = 245) had sufficient data for inclusion in the full analysis population for the SGRQ total score analysis. More patients in the placebo group discontinued the trial than in the tiotropium group (25.7% vs 14.7%, p = 0.0013) (Figure 1). In general, the 2 treatment groups were well matched at baseline (Table 1). However, while the mean ± SD baseline SGRQ total score for all patients was 47.4 ± 18.1, the mean SGRQ total score was significantly higher in the placebo group than the tiotropium group (difference, 3.2; p = 0.046) (Table 1). Furthermore, the mean baseline SGRQ total score was significantly higher in the subgroup of patients with more severe disease (FEV1 ≤ 50% predicted) than in patients with milder disease (FEV1 > 50% predicted) (49.7 vs 43.5, respectively).


Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD.

Tonnel AB, Perez T, Grosbois JM, Verkindre C, Bravo ML, Brun M, TIPHON study gro - Int J Chron Obstruct Pulmon Dis (2008)

Trial flow chart.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2629970&req=5

f1-copd-3-301: Trial flow chart.
Mentions: A total of 555 patients were randomized and 554 received treatment, with 266 receiving tiotropium and 288 receiving placebo (Figure 1). Patients who dropped out but had baseline and post-treatment data were included in the full analysis dataset, following the intent-to-treat principle. 492 patients (tiotropium, n = 247; placebo, n = 245) had sufficient data for inclusion in the full analysis population for the SGRQ total score analysis. More patients in the placebo group discontinued the trial than in the tiotropium group (25.7% vs 14.7%, p = 0.0013) (Figure 1). In general, the 2 treatment groups were well matched at baseline (Table 1). However, while the mean ± SD baseline SGRQ total score for all patients was 47.4 ± 18.1, the mean SGRQ total score was significantly higher in the placebo group than the tiotropium group (difference, 3.2; p = 0.046) (Table 1). Furthermore, the mean baseline SGRQ total score was significantly higher in the subgroup of patients with more severe disease (FEV1 ≤ 50% predicted) than in patients with milder disease (FEV1 > 50% predicted) (49.7 vs 43.5, respectively).

Bottom Line: Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score vs placebo at study end (59.1% vs 48.2%, respectively; p = 0.029).Tiotropium significantly improved spirometric parameters (forced expiratory volume in 1 second [FEV1]: 0.11 +/- 0.02 L vs 0.01 +/- 0.02 L; between-group difference: 0.10 +/- 0.03 L, p = 0.0001) and reduced exacerbations vs placebo.Maintenance treatment with tiotropium provided significant and clinically relevant improvements in HRQoL, as measured by the SGRQ.

View Article: PubMed Central - PubMed

Affiliation: Centre Hospitalier Régional Universitaire (CHRU) de Lille, Service de Pneumologie et Immuno-Allergologie, Lille Cedex, France. ab-tonnel@chru-lille.fr

ABSTRACT
Clinical manifestations of chronic obstructive pulmonary disease (COPD), including airflow limitation, dyspnea, and activity limitation, ultimately lead to impaired health-related quality of life (HRQoL). This 9-month, randomized, double-blind, multicenter study compared the effect of once-daily tiotropium 18 microg and placebo on HRQoL, spirometric parameters, and exacerbations in 554 patients with moderate-to-severe COPD. HRQoL was assessed using the St. George's Respiratory Questionnaire (SGRQ) and the new 8-item Visual Simplified Respiratory Questionnaire (VSRQ), which is currently being validated. The primary efficacy endpoint was the proportion of patients achieving a reduction of at least 4 units in the SGRQ total score at study end (Month 9). Mean +/- SD baseline SGRQ total score was 47.4 +/- 18.1. Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score vs placebo at study end (59.1% vs 48.2%, respectively; p = 0.029). Tiotropium significantly improved spirometric parameters (forced expiratory volume in 1 second [FEV1]: 0.11 +/- 0.02 L vs 0.01 +/- 0.02 L; between-group difference: 0.10 +/- 0.03 L, p = 0.0001) and reduced exacerbations vs placebo. Maintenance treatment with tiotropium provided significant and clinically relevant improvements in HRQoL, as measured by the SGRQ.

Show MeSH
Related in: MedlinePlus