A new dawn

inhaled antibiotics for patients with bronchiectasis

Keith Grimwood, Anne B. Chang

    Research output: Contribution to journalComment/debateResearchpeer-review

    Abstract

    The absence of licensed medications for non-cystic fibrosis bronchiectasis is concerning in the context of the high and increasing burden of bronchiectasis in adults and children. In The Lancet Respiratory Medicine, Charles Haworth and colleagues report promising data from two double-blind randomised controlled trials (ORBIT-3 and ORBIT-4) examining the efficacy of a once-daily inhaled antibiotic composed of liposome-encapsulated ciprofloxacin and free ciprofloxacin (ARD-3150), which is a welcome advancement in the bronchiectasis field in which few such trials exist. In ORBIT-3 and ORBIT-4, Haworth and colleagues enrolled 278 (ORBIT-3) and 304 (ORBIT-4) patients with non-cystic fibrosis bronchiectasis who were chronically infected with Pseudomonas aeruginosa. Patients were randomly assigned (2:1) to receive either ARD-3150 or placebo, which was self-administered once daily for six 56-day treatment cycles, for 48 weeks. The primary endpoint was time to the first pulmonary exacerbation from the date of randomisation to week 48. Treatment with ARD-3150 resulted in a significant prolongation of median time to first pulmonary exacerbation in ORBIT-4 of 230 days compared with 158 days in the placebo group, a difference of 72 days (hazard ratio 0·72 [95% CI 0·53–0·97], p=0·032), but no significant prolongation was observed in ORBIT-3 or a pooled analysis of both trials. Secondary and post-hoc analyses of pooled data revealed significant risk reductions in exacerbation frequency and severity in those receiving ARD-3150, and significant reductions in sputum P aeroginosa density during active treatment cycles, but no between-group changes in quality of life or lung function.
    Original languageEnglish
    Pages (from-to)188-189
    Number of pages2
    JournalThe Lancet Respiratory Medicine
    Volume7
    Issue number3
    Early online date11 Dec 2018
    DOIs
    Publication statusPublished - 1 Mar 2019

    Fingerprint

    Bronchiectasis
    Anti-Bacterial Agents
    Ciprofloxacin
    Lung
    Fibrosis
    Placebos
    Pulmonary Medicine
    Risk Reduction Behavior
    Random Allocation
    Sputum
    Liposomes
    Pseudomonas aeruginosa
    Therapeutics
    Randomized Controlled Trials
    Quality of Life

    Cite this

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    title = "A new dawn: inhaled antibiotics for patients with bronchiectasis",
    abstract = "The absence of licensed medications for non-cystic fibrosis bronchiectasis is concerning in the context of the high and increasing burden of bronchiectasis in adults and children. In The Lancet Respiratory Medicine, Charles Haworth and colleagues report promising data from two double-blind randomised controlled trials (ORBIT-3 and ORBIT-4) examining the efficacy of a once-daily inhaled antibiotic composed of liposome-encapsulated ciprofloxacin and free ciprofloxacin (ARD-3150), which is a welcome advancement in the bronchiectasis field in which few such trials exist. In ORBIT-3 and ORBIT-4, Haworth and colleagues enrolled 278 (ORBIT-3) and 304 (ORBIT-4) patients with non-cystic fibrosis bronchiectasis who were chronically infected with Pseudomonas aeruginosa. Patients were randomly assigned (2:1) to receive either ARD-3150 or placebo, which was self-administered once daily for six 56-day treatment cycles, for 48 weeks. The primary endpoint was time to the first pulmonary exacerbation from the date of randomisation to week 48. Treatment with ARD-3150 resulted in a significant prolongation of median time to first pulmonary exacerbation in ORBIT-4 of 230 days compared with 158 days in the placebo group, a difference of 72 days (hazard ratio 0·72 [95{\%} CI 0·53–0·97], p=0·032), but no significant prolongation was observed in ORBIT-3 or a pooled analysis of both trials. Secondary and post-hoc analyses of pooled data revealed significant risk reductions in exacerbation frequency and severity in those receiving ARD-3150, and significant reductions in sputum P aeroginosa density during active treatment cycles, but no between-group changes in quality of life or lung function.",
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    A new dawn : inhaled antibiotics for patients with bronchiectasis. / Grimwood, Keith; Chang, Anne B.

    In: The Lancet Respiratory Medicine, Vol. 7, No. 3, 01.03.2019, p. 188-189.

    Research output: Contribution to journalComment/debateResearchpeer-review

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    T2 - inhaled antibiotics for patients with bronchiectasis

    AU - Grimwood, Keith

    AU - Chang, Anne B.

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    N2 - The absence of licensed medications for non-cystic fibrosis bronchiectasis is concerning in the context of the high and increasing burden of bronchiectasis in adults and children. In The Lancet Respiratory Medicine, Charles Haworth and colleagues report promising data from two double-blind randomised controlled trials (ORBIT-3 and ORBIT-4) examining the efficacy of a once-daily inhaled antibiotic composed of liposome-encapsulated ciprofloxacin and free ciprofloxacin (ARD-3150), which is a welcome advancement in the bronchiectasis field in which few such trials exist. In ORBIT-3 and ORBIT-4, Haworth and colleagues enrolled 278 (ORBIT-3) and 304 (ORBIT-4) patients with non-cystic fibrosis bronchiectasis who were chronically infected with Pseudomonas aeruginosa. Patients were randomly assigned (2:1) to receive either ARD-3150 or placebo, which was self-administered once daily for six 56-day treatment cycles, for 48 weeks. The primary endpoint was time to the first pulmonary exacerbation from the date of randomisation to week 48. Treatment with ARD-3150 resulted in a significant prolongation of median time to first pulmonary exacerbation in ORBIT-4 of 230 days compared with 158 days in the placebo group, a difference of 72 days (hazard ratio 0·72 [95% CI 0·53–0·97], p=0·032), but no significant prolongation was observed in ORBIT-3 or a pooled analysis of both trials. Secondary and post-hoc analyses of pooled data revealed significant risk reductions in exacerbation frequency and severity in those receiving ARD-3150, and significant reductions in sputum P aeroginosa density during active treatment cycles, but no between-group changes in quality of life or lung function.

    AB - The absence of licensed medications for non-cystic fibrosis bronchiectasis is concerning in the context of the high and increasing burden of bronchiectasis in adults and children. In The Lancet Respiratory Medicine, Charles Haworth and colleagues report promising data from two double-blind randomised controlled trials (ORBIT-3 and ORBIT-4) examining the efficacy of a once-daily inhaled antibiotic composed of liposome-encapsulated ciprofloxacin and free ciprofloxacin (ARD-3150), which is a welcome advancement in the bronchiectasis field in which few such trials exist. In ORBIT-3 and ORBIT-4, Haworth and colleagues enrolled 278 (ORBIT-3) and 304 (ORBIT-4) patients with non-cystic fibrosis bronchiectasis who were chronically infected with Pseudomonas aeruginosa. Patients were randomly assigned (2:1) to receive either ARD-3150 or placebo, which was self-administered once daily for six 56-day treatment cycles, for 48 weeks. The primary endpoint was time to the first pulmonary exacerbation from the date of randomisation to week 48. Treatment with ARD-3150 resulted in a significant prolongation of median time to first pulmonary exacerbation in ORBIT-4 of 230 days compared with 158 days in the placebo group, a difference of 72 days (hazard ratio 0·72 [95% CI 0·53–0·97], p=0·032), but no significant prolongation was observed in ORBIT-3 or a pooled analysis of both trials. Secondary and post-hoc analyses of pooled data revealed significant risk reductions in exacerbation frequency and severity in those receiving ARD-3150, and significant reductions in sputum P aeroginosa density during active treatment cycles, but no between-group changes in quality of life or lung function.

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    JO - The Lancet Respiratory Medicine

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