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Double-blind study of OM-85 in patients with chronic bronchitis or mild chronic obstructive pulmonary disease.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Soler, M. A. González Mütterlein, Ralph Cozma, Gabriel |
| Copyright Year | 2007 |
| Abstract | BACKGROUND Interventions against acute exacerbations (AEs) of chronic obstructive pulmonary disease (COPD) are increasingly called for to reduce morbidity, mortality and costs. OM-85, a detoxified immunoactive bacterial extract, has been shown to prevent recurrent exacerbations of bronchitis and COPD. OBJECTIVES It was the aim of this study to demonstrate the protective effect of OM-85 against recurrent bronchitic exacerbations in patients with chronic bronchitis or mild COPD. The primary end point was the mean rate of AEs occurring within the study period. METHODS This double-blind multi-centre study enrolled adult outpatients>40 years old of both sexes with a history of chronic bronchitis or mild COPD at the time of an AE. The treatment consisted of one capsule of OM-85 or placebo per day for 30 days, followed by three 10-day courses for months 3, 4 and 5, with a 6-month study duration and monthly control visits. RESULTS One hundred and forty-two patients were treated with OM-85 and 131 received placebo. By the end of the treatment period, the mean number of AEs in the OM-85 group was 0.61 per patient versus 0.86 per patient in the placebo group (-29%; p=0.03). The difference between treatments was most notable in patients with a history of current or past smoking (-40%; p<0.01). No serious adverse events were attributed to the medication and no significant laboratory changes were reported. CONCLUSIONS OM-85 significantly reduced the frequency of AEs in patients with a history of chronic bronchitis and mild COPD and was well tolerated. This study confirms the findings of previous trials conducted in elderly patients with chronic bronchitis or COPD. |
| Starting Page | 26 |
| Ending Page | 32 |
| Page Count | 7 |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://www.assospharma.com/pdf/vaxoral2/9-Soler1997.pdf |
| PubMed reference number | 16772707v1 |
| Volume Number | 74 |
| Issue Number | 1 |
| Journal | Respiration; international review of thoracic diseases |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Acute inflammatory demyelinating polyneuropathy Adverse event Arabic numeral 100 Asthma Bronchitis Bronchitis, Chronic Chronic Obstructive Airway Disease Lung Diseases, Obstructive Lung diseases Morbidity - disease rate Numerous Patients Smoke |
| Content Type | Text |
| Resource Type | Article |
