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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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Adjusted mean (SE) change from baseline in SGRQ scores in patients taking tiotropium or placebo: a) change in total score during the 9-month study; and b) change in domain scores at study end (means adjusted for baseline SGRQ scores).
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f3-copd-3-301: Adjusted mean (SE) change from baseline in SGRQ scores in patients taking tiotropium or placebo: a) change in total score during the 9-month study; and b) change in domain scores at study end (means adjusted for baseline SGRQ scores).

Mentions: Tiotropium significantly improved the SGRQ total score on each test day, compared with placebo (all p < 0.05) (Figure 3a). At study end, adjusted mean (SE) change from baseline SGRQ total scores was −8.50 (0.90) for tiotropium and −4.32 (0.90) for placebo. The difference between the 2 groups exceeded the change of at least 4 units in the SGRQ total score currently regarded as meaningful (difference, −4.19 [95% CI, −6.68 to −1.69]; p = 0.001). Furthermore, compared with placebo, tiotropium significantly improved all 3 SGRQ domain scores at study end (all p < 0.05) (Figure 3b).


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)

Adjusted mean (SE) change from baseline in SGRQ scores in patients taking tiotropium or placebo: a) change in total score during the 9-month study; and b) change in domain scores at study end (means adjusted for baseline SGRQ scores).
© Copyright Policy
Related In: Results  -  Collection

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

f3-copd-3-301: Adjusted mean (SE) change from baseline in SGRQ scores in patients taking tiotropium or placebo: a) change in total score during the 9-month study; and b) change in domain scores at study end (means adjusted for baseline SGRQ scores).
Mentions: Tiotropium significantly improved the SGRQ total score on each test day, compared with placebo (all p < 0.05) (Figure 3a). At study end, adjusted mean (SE) change from baseline SGRQ total scores was −8.50 (0.90) for tiotropium and −4.32 (0.90) for placebo. The difference between the 2 groups exceeded the change of at least 4 units in the SGRQ total score currently regarded as meaningful (difference, −4.19 [95% CI, −6.68 to −1.69]; p = 0.001). Furthermore, compared with placebo, tiotropium significantly improved all 3 SGRQ domain scores at study end (all p < 0.05) (Figure 3b).

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