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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

CONSORT diagram of the flow of participants. All randomised participants were included in the analysis. The subjects who had withdrawn from the study medication remained for the full assessment period and were reviewed at the final visit day, as far as possible
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Fig1: CONSORT diagram of the flow of participants. All randomised participants were included in the analysis. The subjects who had withdrawn from the study medication remained for the full assessment period and were reviewed at the final visit day, as far as possible

Mentions: The screening, randomisation, withdrawals and protocol deviations are shown in the CONSORT diagram (Fig. 1). Of the 717 patients initially assessed for eligibility, 292 were randomised. Of the 425 excluded subjects, 248 had negative C. pneumoniae serology with 77 subjects having fewer than three documented exacerbations over the preceding two-year period. Table 1 compares the characteristics of the 292 included and 425 excluded subjects. Apart from the known difference in C. pneumoniae serological status, the major differences were that the included cohort comprised a greater proportion of men (73 % vs. 63 %), worse baseline forced expiratory volume in 1 second (FEV1) (mean FEV1 predicted 34 % vs. 43 %) and a greater number of exacerbations (5.1 vs. 4.1 exacerbations within the previous 2 years) than the excluded cohort.Fig. 1


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)

CONSORT diagram of the flow of participants. All randomised participants were included in the analysis. The subjects who had withdrawn from the study medication remained for the full assessment period and were reviewed at the final visit day, as far as possible
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig1: CONSORT diagram of the flow of participants. All randomised participants were included in the analysis. The subjects who had withdrawn from the study medication remained for the full assessment period and were reviewed at the final visit day, as far as possible
Mentions: The screening, randomisation, withdrawals and protocol deviations are shown in the CONSORT diagram (Fig. 1). Of the 717 patients initially assessed for eligibility, 292 were randomised. Of the 425 excluded subjects, 248 had negative C. pneumoniae serology with 77 subjects having fewer than three documented exacerbations over the preceding two-year period. Table 1 compares the characteristics of the 292 included and 425 excluded subjects. Apart from the known difference in C. pneumoniae serological status, the major differences were that the included cohort comprised a greater proportion of men (73 % vs. 63 %), worse baseline forced expiratory volume in 1 second (FEV1) (mean FEV1 predicted 34 % vs. 43 %) and a greater number of exacerbations (5.1 vs. 4.1 exacerbations within the previous 2 years) than the excluded cohort.Fig. 1

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