Effects of formoterol and ipratropium bromide in COPD: a 3-month placebo-controlled study

Wadbo, Monika; Löfdahl, Claes-Göran; Larsson, Kjell; Skoogh, Bengt-Eric; Tornling, Göran; Arweström, Ewa; Bengtsson, Thomas; Ström, Kerstin

doi:10.1183/09031936.02.00301702

Cited by 81 publications

(52 citation statements)

References 27 publications

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“…In this study, we have now shown that tiotropium also provides significant improvements in SWT distance compared with placebo. At study end, tiotropium increased the mean distance walked by 36 m compared with placebo, which could be considered a clinically meaningful improvement [31]. Cycle ergometry and the SWT provide different, but complementary, information.…”

Section: Discussionmentioning

confidence: 99%

The Effect of Tiotropium on Hyperinflation and Exercise Capacity in Chronic Obstructive Pulmonary Disease

et al. 2006

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Background: Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation, which results in the progressive development of dyspnea and exercise limitation. Objective and Methods: To compare the effect of tiotropium with placebo on forced vital capacity (FVC) in patients with moderate-to-severe COPD and lung hyperinflation, using exercise endurance, dyspnea and health-related quality of life (HRQoL) as secondary endpoints. One hundred patients were randomized to receive either tiotropium 18 µg once daily or placebo for 12 weeks. Results: Trough (predose) FVC was significantly improved with tiotropium compared to placebo on day 42 (0.27 ± 0.08 liters) and 84 (0.20 ± 0.08 liters; p < 0.05 for both). Trough inspiratory capacity (IC) was also significantly improved with tiotropium compared to placebo on day 42 (0.16 ± 0.07 liters) and 84 (0.15 ± 0.07 liters; p < 0.05 for both). Tiotropium increased the mean distance walked during the shuttle walking test by 33 ± 12 (day 42) and 36 ± 14 m (day 84) compared to placebo (p < 0.05 for both). On day 84, 59% of the patients in the tiotropium group and 35% of the patients in the placebo group had significant and clinically meaningful improvements in the St. George’s Respiratory Questionnaire total score (p < 0.05). Numerical decreases in the focal score in the Transition Dyspnea Index in patients receiving tiotropium versus placebo suggest that tiotropium also improved dyspnea during activities of daily living. Conclusion: Tiotropium 18 µg once daily reduced hyperinflation with consequent improvements in walking distance and HRQoL in patients with COPD and lung hyperinflation.

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Section: Discussionmentioning

confidence: 99%

The Effect of Tiotropium on Hyperinflation and Exercise Capacity in Chronic Obstructive Pulmonary Disease

et al. 2006

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“…A large rehabilitation study reported mean changes of 75.9 m [281]. In a large group of patients with COPD, the SWT was sensitive to the administration of formoterol and ipratopium bromide [283,284]. The endurance SWT (ESWT) seems more sensitive to change after a course of rehabilitation than the ISWT.…”

Section: Walking Testsmentioning

confidence: 99%

Recommendations on the use of exercise testing in clinical practice

Palange¹,

Ward²,

Carlsen³

et al. 2006

European Respiratory Journal

549

390

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Evidence-based recommendations on the clinical use of cardiopulmonary exercise testing (CPET) in lung and heart disease are presented, with reference to the assessment of exercise intolerance, prognostic assessment and the evaluation of therapeutic interventions (e.g. drugs, supplemental oxygen, exercise training). A commonly used grading system for recommendations in evidence-based guidelines was applied, with the grade of recommendation ranging from A, the highest, to D, the lowest.For symptom-limited incremental exercise, CPET indices, such as peak O 2 uptake (V9O 2 ), V9O 2 at lactate threshold, the slope of the ventilation-CO 2 output relationship and the presence of arterial O 2 desaturation, have all been shown to have power in prognostic evaluation. In addition, for assessment of interventions, the tolerable duration of symptom-limited high-intensity constant-load exercise often provides greater sensitivity to discriminate change than the classical incremental test. Field-testing paradigms (e.g. timed and shuttle walking tests) also prove valuable.In turn, these considerations allow the resolution of practical questions that often confront the clinician, such as: 1) ''When should an evaluation of exercise intolerance be sought?''; 2) ''Which particular form of test should be asked for?''; and 3) ''What cluster of variables should be selected when evaluating prognosis for a particular disease or the effect of a particular intervention?''

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“…[1] The goals of COPD therapy include QOL). [2][3][4][5][6] Inhaled corticosteroids (ICSs) reduce the (i) improvements in airflow, exercise tolerance, frequency of exacerbations, [7][8][9] but have shown inhealth status and COPD symptoms (e.g. dyspnoea); consistent results in terms of reduction in mortality (ii) prevention of disease progression and exacerba-and modest effects with respect to improvement in tions; and (iii) a reduction in mortality.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Budesonide and Formoterol in One Pressurized Metered-Dose Inhaler in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Tashkin

Rennard

Martin

et al. 2008

Drugs

180

219

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Abstractacting bronchodilator is recommended in the treatment of patients with chronic obstructive pulmonary disease (COPD) who have frequent exacerbations. Budesonide/formoterol dry powder inhaler (DPI) has demonstrated efficacy and tolerability in patients with COPD. Objective: To evaluate the efficacy and tolerability of budesonide/formoterol administered via one hydrofluoroalkane pressurized metered-dose inhaler (pMDI) in patients with COPD. Methods: This was a 6-month, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicentre study (NCT00206154) of 1704 patients aged ≥40 years with moderate to very severe COPD conducted in 194 centres in the US, Czech Republic, the Netherlands, Poland and South Africa. After 2 weeks of treatment based on previous therapy (ICSs and short-acting bronchodilators allowed during the run-in period), patients received one of the following treatments administered twice daily: budesonide/formoterol pMDI 160/4.5 μg × two inhalations (320/9 μg); budesonide/formoterol pMDI 80/4.5 μg × two inhalations (160/9 μg); budesonide pMDI 160 μg × two inhalations (320 μg) plus formoterol DPI 4.5 μg × two inhalations (9 μg); budesonide pMDI 160 μg × two inhalations (320 μg); formoterol DPI 4.5 μg × two inhalations (9 μg); or placebo. Main outcome measures:The co-primary efficacy variables were pre-dose forced expiratory volume in 1 second (FEV1) and 1-hour post-dose FEV1. Results: Budesonide/formoterol 320/9 μg demonstrated significantly greater improvements in pre-dose FEV1 versus formoterol (p = 0.026; pre-specified primary comparator) and 1-hour post-dose FEV1 versus budesonide (p < 0.001; pre-specified primary comparator); budesonide/formoterol 160/9 μg demonstrated significantly greater improvements versus budesonide (p < 0.001) for 1-hour post-dose FEV1 but not versus formoterol for pre-dose FEV1. Dyspnoea (measured using the Breathlessness Diary) and health-related quality-of-life (HR-QOL) scores (based on the St George's Respiratory Questionnaire total score) were significantly improved with both dosage strengths of budesonide/formoterol compared with budesonide, formoterol and placebo (p ≤ 0.044 for all). Although not powered a priori for comparisons, the number of exacerbations per patienttreatment year requiring treatment with oral corticosteroids and/or hospitalization was numerically (20-25%) lower with the budesonide-containing treatments (0.710-0.884) versus formoterol (1.098) and placebo (1.110). This result was driven by the exacerbations requiring treatment with oral corticosteroids (79-120 events). The number of exacerbations resulting in hospitalization was very low across treatment groups (11-22); the number per patient-treatment year was significantly different for budesonide/formoterol 320/9 μg (0.158) versus other treatment groups (0.081-0.108) except budesonide/formoterol 160/9 μg (0.139), and for budesonide/formoterol 160/9 μg versus formoterol (0.081) [p ≤ 0.05]. All treatments were generally well tolerated. The incidence of individual non-f...

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Effects of formoterol and ipratropium bromide in COPD: a 3-month placebo-controlled study

Cited by 81 publications

References 27 publications

The Effect of Tiotropium on Hyperinflation and Exercise Capacity in Chronic Obstructive Pulmonary Disease

The Effect of Tiotropium on Hyperinflation and Exercise Capacity in Chronic Obstructive Pulmonary Disease

Recommendations on the use of exercise testing in clinical practice

Efficacy and Safety of Budesonide and Formoterol in One Pressurized Metered-Dose Inhaler in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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