Chest

Chest

Volume 115, Issue 5, May 1999, Pages 1338-1345
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Clinical Investigations
SLEEP AND BREATHING
Effect of Ipratropium Bromide Treatment on Oxygen Saturation and Sleep Quality in COPD

https://doi.org/10.1378/chest.115.5.1338Get rights and content

Study objectives

Patients with COPD are at risk of experiencing a deterioration in arterial oxygen saturation (Sao2) during sleep, which is generally most pronounced during rapid eye movement (REM) sleep. Increased cholinergic tone has been suggested as a contributing factor to this decrease in Sao2. Therefore, we investigated whether 4-week treatment with ipratropium bromide inhalation solution 0.02% (qid) could improve sleep characteristics in COPD.

Design

Randomized, placebo-controlled, double-blind, two-arm parallel study of 4 weeks of treatment with ipratropium bromide solution or placebo.

Setting

Multicenter investigation.

Patients

Thirty-six patients with moderate-to-severe COPD (FEV1 < 65% of predicted).

Measurements and results

Evaluation included polysomnographic, pulmonary function, and subjective quality of sleep (visual analog scale [VAS]) assessments. It was found that 4 week of treatment with ipratropium bromide solution in patients with COPD led to the following: (1) a significant (p = 0.05) improvement in mean nocturnal Sao2 with the more severe the nocturnal desaturation, the greater the improvement in Sao2; (2) significant (p = 0.03) improvement in perceived sleep quality (VAS: 5.5 ± 0.5 after placebo; 7.2 ± 0.5 after ipratropium); (3) a significant (p = 0.05) increase in REM sleep time (48.6 ± 6.3 min after placebo; 66.5 ± 6.4 min after ipratropium) with no effect on other sleep stages or total sleep time; and (4) a significant (p = 0.01) increase in pre-sleep FVC and flow rate at 50% of the vital capacity.

Conclusions

These findings demonstrate that ipratropium bromide therapy can improve sleep Sao2 as well as sleep quality in patients with moderate-to-severe COPD.

Section snippets

Subjects

Seventy-five patients with COPD were screened to enroll 36 patients into the study from four centers that met all study criteria. The baseline demographic and respiratory characteristics are summarized in Table 1. The diagnosis of COPD followed the American Thoracic Society definition.12 This study included both male and female patients between the ages of 40 and 75 years with a history of > 10 pack-years of smoking. The FEV1 needed to be < 65% of predicted and relative stability of symptoms

Patients’ Demographics and Lung Function on Entry Into the Study

Thirty-six subjects were enrolled into the study. The baseline demographic and respiratory characteristics of these patients are shown in Table 1. One IB-treated patient withdrew secondary to headaches during the treatment phase. In addition, one placebo-treated patient with a concomitant diagnosis of depression suffered an adverse event described as depression of moderate intensity lasting 2 days during the treatment phase. Sleep data collection for this patient was not complete. These two

Discussion

The quality of sleep in many patients with COPD is significantly compromised. As indicated by objective measures such as reduced sleep time, increased sleep stage shifts, and increased arousal frequency, patients with COPD generally sleep poorly. These patients also complain of difficulty with sleep onset and sleep maintenance.2348 Several studies detected that these patients have a significant and frequent decrease in nocturnal Sao2.2345678 According to some studies, the most marked reduction

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    Supported by a grant from Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT.

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    Copyright © 1999 The American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.