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A double-blind, randomised, placebo-controlled study of roxithromycin and doxycycline combination, roxithromycin alone, or matching placebo for 12 weeks in adults with frequent exacerbations of chronic obstructive pulmonary disease.

Shafuddin E, Mills GD, Holmes MD, Poole PJ, Mullins PR, Black PN - J Negat Results Biomed (2015)

Bottom Line: There were no differences in the annualised moderate and severe exacerbation rates after treatment with roxithromycin/doxycycline (2.83 (95 % CI 2.37-3.40)) or roxithromycin only (2.69 (2.26-3.21)) compared to placebo (2.5 (2.08-3.03)) (p = 0.352 and p = 0.5832 respectively).There were also no significant differences between groups for spirometry or quality of life scores over either the 12-week treatment or 48-week post-treatment periods.Both active treatments were associated with nausea but otherwise adverse events were comparable among treatment groups.

View Article: PubMed Central - PubMed

Affiliation: Respiratory Research Unit, Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand. eskandarain.shafuddin@waikatodhb.health.nz.

ABSTRACT

Background: Azithromycin prophylaxis has been shown to reduce COPD exacerbations but there is poor evidence for other antibiotics. We compared exacerbation rates in COPD patients with a history of frequent exacerbations (at least three moderate or severe COPD exacerbations in the past two years) during a 12-week treatment course and over a subsequent 48-week follow up period.

Results: 292 patients were randomised to one of three treatments for 12 weeks: roxithromycin 300 mg daily and doxycycline 100 mg daily (n = 101); roxithromycin 300 mg daily (n = 97); or matching placebos (n = 94). There were no differences in the annualised moderate and severe exacerbation rates after treatment with roxithromycin/doxycycline (2.83 (95 % CI 2.37-3.40)) or roxithromycin only (2.69 (2.26-3.21)) compared to placebo (2.5 (2.08-3.03)) (p = 0.352 and p = 0.5832 respectively). Furthermore, there were no differences in the annualised exacerbation rates during 12-week treatment with roxithromycin/doxycycline (1.64 (95 % CI 1.17-2.30)), roxithromycin only (1.75 (1.24-2.41)) or placebo (2.23 (1.68-3.03)) (p = 0.1709 and p = 0.2545 respectively). There were also no significant differences between groups for spirometry or quality of life scores over either the 12-week treatment or 48-week post-treatment periods. Both active treatments were associated with nausea but otherwise adverse events were comparable among treatment groups.

Conclusions: Twelve-weeks of prophylaxis with roxithromycin/doxycycline combination or roxithromycin alone did not reduce COPD exacerbations in patients with history of frequent exacerbations. These findings do not support the use of these antibiotics to prevent exacerbations in COPD patients.

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Related in: MedlinePlus

Time-course of spirometry by treatment groups. Trend from baseline to week 12 (end of treatment), week 36 and week 60 (end of follow up period) for a) mean absolute FEV1, b) FEV1 percentage predicted, c) mean absolute FVC and d) FEV1/FVC, by treatment groups
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Fig2: Time-course of spirometry by treatment groups. Trend from baseline to week 12 (end of treatment), week 36 and week 60 (end of follow up period) for a) mean absolute FEV1, b) FEV1 percentage predicted, c) mean absolute FVC and d) FEV1/FVC, by treatment groups

Mentions: By the end of the active treatment period (Fig. 2a), FEV1 increased by 5.5 % (47 mls) relative to baseline in the roxithromycin/doxycycline group, 5.9 % (57 mls) in the roxithromycin only group and 8.4 % (83 mls) in the placebo group. This remained more or less the same at 24 weeks and 48 weeks after treatment. These small improvements in FEV1 over the 60-week study period were statistically significant in all groups (p < 0.0001). Overall there was no significant difference among the treatment groups at the end of the study (p = 0.278). With regard to the change seen over time, there was no significant difference among the treatment groups (p = 0.539). By the end of the active treatment period (Fig. 2c), FVC increased by 2.8 % (60 mls) relative to baseline in the roxithromycin/doxycycline group, 3.9 % (90 mls) in the roxithromycin only group and 1.9 % (43 mls) in the placebo group but these were not statistically significant (p = 0.3441), and overall there was no significant difference among the treatment groups (p = 0.7192).Fig. 2


A double-blind, randomised, placebo-controlled study of roxithromycin and doxycycline combination, roxithromycin alone, or matching placebo for 12 weeks in adults with frequent exacerbations of chronic obstructive pulmonary disease.

Shafuddin E, Mills GD, Holmes MD, Poole PJ, Mullins PR, Black PN - J Negat Results Biomed (2015)

Time-course of spirometry by treatment groups. Trend from baseline to week 12 (end of treatment), week 36 and week 60 (end of follow up period) for a) mean absolute FEV1, b) FEV1 percentage predicted, c) mean absolute FVC and d) FEV1/FVC, by treatment groups
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4562194&req=5

Fig2: Time-course of spirometry by treatment groups. Trend from baseline to week 12 (end of treatment), week 36 and week 60 (end of follow up period) for a) mean absolute FEV1, b) FEV1 percentage predicted, c) mean absolute FVC and d) FEV1/FVC, by treatment groups
Mentions: By the end of the active treatment period (Fig. 2a), FEV1 increased by 5.5 % (47 mls) relative to baseline in the roxithromycin/doxycycline group, 5.9 % (57 mls) in the roxithromycin only group and 8.4 % (83 mls) in the placebo group. This remained more or less the same at 24 weeks and 48 weeks after treatment. These small improvements in FEV1 over the 60-week study period were statistically significant in all groups (p < 0.0001). Overall there was no significant difference among the treatment groups at the end of the study (p = 0.278). With regard to the change seen over time, there was no significant difference among the treatment groups (p = 0.539). By the end of the active treatment period (Fig. 2c), FVC increased by 2.8 % (60 mls) relative to baseline in the roxithromycin/doxycycline group, 3.9 % (90 mls) in the roxithromycin only group and 1.9 % (43 mls) in the placebo group but these were not statistically significant (p = 0.3441), and overall there was no significant difference among the treatment groups (p = 0.7192).Fig. 2

Bottom Line: There were no differences in the annualised moderate and severe exacerbation rates after treatment with roxithromycin/doxycycline (2.83 (95 % CI 2.37-3.40)) or roxithromycin only (2.69 (2.26-3.21)) compared to placebo (2.5 (2.08-3.03)) (p = 0.352 and p = 0.5832 respectively).There were also no significant differences between groups for spirometry or quality of life scores over either the 12-week treatment or 48-week post-treatment periods.Both active treatments were associated with nausea but otherwise adverse events were comparable among treatment groups.

View Article: PubMed Central - PubMed

Affiliation: Respiratory Research Unit, Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand. eskandarain.shafuddin@waikatodhb.health.nz.

ABSTRACT

Background: Azithromycin prophylaxis has been shown to reduce COPD exacerbations but there is poor evidence for other antibiotics. We compared exacerbation rates in COPD patients with a history of frequent exacerbations (at least three moderate or severe COPD exacerbations in the past two years) during a 12-week treatment course and over a subsequent 48-week follow up period.

Results: 292 patients were randomised to one of three treatments for 12 weeks: roxithromycin 300 mg daily and doxycycline 100 mg daily (n = 101); roxithromycin 300 mg daily (n = 97); or matching placebos (n = 94). There were no differences in the annualised moderate and severe exacerbation rates after treatment with roxithromycin/doxycycline (2.83 (95 % CI 2.37-3.40)) or roxithromycin only (2.69 (2.26-3.21)) compared to placebo (2.5 (2.08-3.03)) (p = 0.352 and p = 0.5832 respectively). Furthermore, there were no differences in the annualised exacerbation rates during 12-week treatment with roxithromycin/doxycycline (1.64 (95 % CI 1.17-2.30)), roxithromycin only (1.75 (1.24-2.41)) or placebo (2.23 (1.68-3.03)) (p = 0.1709 and p = 0.2545 respectively). There were also no significant differences between groups for spirometry or quality of life scores over either the 12-week treatment or 48-week post-treatment periods. Both active treatments were associated with nausea but otherwise adverse events were comparable among treatment groups.

Conclusions: Twelve-weeks of prophylaxis with roxithromycin/doxycycline combination or roxithromycin alone did not reduce COPD exacerbations in patients with history of frequent exacerbations. These findings do not support the use of these antibiotics to prevent exacerbations in COPD patients.

Show MeSH
Related in: MedlinePlus