J Korean Med Sci.  2007 Oct;22(5):839-845. 10.3346/jkms.2007.22.5.839.

The Combination of Tiotropium and Budesonide in the Treatment of Chronic Obstructive Pulmonary Disease

• Um SW
• Yoo CG
• Kim YW
• Han SK
• Shim YS

• KMID: 1713290
• DOI: http://doi.org/10.3346/jkms.2007.22.5.839

Abstract

Because additive effects of inhaled corticosteroids and long-acting anticholinergics are unclear, we undertook this study to compare the efficacy of tiotropium alone and tiotropium plus budesonide in patients with chronic obstructive pulmonary disease. The study subjects were randomized to receive either tiotropium 18 microgram once daily with or without budesonide 200 microgram twice daily for 6 weeks. The efficacy variables were changes in trough forced expiratory volume in one second (FEV1), St. George's Respiratory Questionnaire (SGRQ), 6-minute walk distance (6MWD), and use of rescue medication. One hundred patients were randomized and 81 completed the study. The mean age was 64.0 yr, and the mean FEV1 was 39.7% predicted. Compared with tiotropium alone (N=40), the tiotropium/budesonide combination (N=41) was related to an improvement in the SGRQ total score (tiotropium -2.8 units and tiotropium/budesonide -5.6 units, p=0.003). 6MWD was improved by 13.5 m in the tiotropium group and by 22.5 m in the tiotropium/budesonide group (p=0.031). Changes in trough FEV1 and the use of rescue medication were similar between two groups. In conclusion, compared with tiotropium alone, the tiotropium/ budesonide combination was related to an improved health-related quality of life. These data support that low-dose budesonide may enhance the efficacy of tiotropium.

Keyword

Pulmonary Disease, Chronic Obstructive; Budesonide; Tiotropium; Quality of Life; Exercise; Spirometry

MeSH Terms

Aged
Bronchodilator Agents/*administration & dosage
Budesonide/*administration & dosage
Exercise
Female
Humans
Male
Middle Aged
Models, Statistical
Pulmonary Disease, Chronic Obstructive/*drug therapy
Quality of Life
Questionnaires
Scopolamine Derivatives/*administration & dosage
Spirometry/methods
Treatment Outcome

Figure

• 

  Fig. 1 Mean trough FEV1 differences before and after 6 weeks of treatment in tiotropium (46.4±10.4 mL) and tiotropium/budesonide (61.0±14.5 mL) groups (p>0.05). Δ, change in; FEV1, forced expiratory volume in one second.

• 

  Fig. 2 Mean differences in SGRQ total and subscale scores (symptoms, activity, and impact scores) before and after 6-week treatment in tiotropium and tiotropium/budesonide groups. Δ, change in; SGRQ, St George's Respiratory Questionnaire. *, p<0.05 for the group comparison.

• 

  Fig. 3 Mean 6MWD differences before and after 6 weeks of treatment in tiotropium (13.5±1.9 m) and tiotropium/budesonide groups (22.5±2.4 m). Δ, change in; 6MWD, 6-minute walk distance. *, p<0.05 for the group comparison.

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