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Use of a mucus clearance device enhances the bronchodilator response in patients with stable COPD
Wolkove N, Kamel H, Rotaple M, Baltzan MA Jr
Chest 2002 Mar;121(3 Suppl):702-707
clinical trial
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY OBJECTIVE: To determine whether the use of a mucus clearance device (MCD) (Flutter; Axcan Scandipharm; Birmingham, AL) could improve the bronchodilator response to inhaled ipratropium and salbutamol delivered by a metered-dose inhaler in patients with stable, severe COPD. PATIENTS: Twenty-three patients with severe COPD were studied. Mean +/- SD age was 71.7 +/- 6.3 years. Mean FEV1 was 0.74 +/- 0.28 L or 34.5 +/- 12.7% predicted. METHODS: Patients were tested in random order on 2 subsequent days after using an MCD or a sham MCD. A bronchodilator (four puffs; each puff delivering 20 mug of ipratropium bromide and 120 mug of salbutamol sulfate) was administered by metered-dose inhaler with a holding chamber after use of the MCD or sham MCD. Spirometry was performed before and after use of the MCD or sham MCD, and at 30 min, 60 min, and 120 min after the bronchodilator. Six-minute walk distance was tested between 30 min and 60 min; oxygen saturation, pulse, and a dyspnea score were recorded before and after walking. RESULTS: Immediately after use of the MCD, but not the sham MCD, there was a statistically significant (p < 0.05) improvement in FEV1 and FVC (11 +/- 24% versus 1 +/- 7% and 18 +/- 33% versus 6 +/- 18%, respectively). Whether patients were pretreated with the MCD or sham MCD, there was a significant improvement in FEV1 and FVC compared to baseline with combined bronchodilator therapy. At 120 min, the change in FEV1 after treatment with the MCD was greater than with the sham MCD (186 +/- 110 mL versus 130 +/- 120 mL; p < 0.05). When comparing the MCD to the sham MCD, 6-min walk distance was greater (174 +/- 92 m versus 162 +/- 86 m; p +/- 0.05), with less dyspnea before and at the end of walking. CONCLUSION: Patients with severe COPD may demonstrate a significant bronchodilator response to combined ipratropium and salbutamol delivered by metered-dose inhaler. This response may be enhanced and additional functional improvement obtained with the prior use of a bronchial MCD.

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