TY - JOUR
T1 - The azithromycin to prevent wheezing following severe RSV bronchiolitis-II clinical trial
T2 - Rationale, study design, methods, and characteristics of study population
AU - Srinivasan, Mythili
AU - Bacharier, Leonard B.
AU - Goss, Charles W.
AU - Zhou, Yanjiao
AU - Boomer, Jonathan
AU - Bram, Sarah
AU - Burgdorf, Dana
AU - Burnham, Carey Ann
AU - Casper, Timothy
AU - Castro, Mario
AU - Coverstone, Andrea
AU - Haslam, Matthew
AU - Kanchongkittiphon, Watcharoot
AU - Kuklinski, Cadence
AU - Lian, Qinghua
AU - Schechtman, Kenneth
AU - Storch, Gregory A.
AU - True, Kelly
AU - Wallace, Meghan A.
AU - Yin-DeClue, Huiqing
AU - Ahrens, Elizabeth
AU - Wang, Jinli
AU - Beigelman, Avraham
N1 - Publisher Copyright:
© 2021
PY - 2021/6
Y1 - 2021/6
N2 - Severe respiratory syncytial virus (RSV) bronchiolitis in early life is a significant risk factor for future recurrent wheeze (RW) and asthma. The goal of the Azithromycin to Prevent Wheezing following severe RSV bronchiolitis II (APW-RSV II) clinical trial is to evaluate if azithromycin treatment in infants hospitalized with RSV bronchiolitis reduces the occurrence of RW during the preschool years. The APW-RSV II clinical trial is a double-blind, placebo-controlled, parallel-group, randomized trial, including otherwise healthy participants, ages 30 days-18 months, who are hospitalized due to RSV bronchiolitis. The study includes an active randomized treatment phase with azithromycin or placebo for 2 weeks, and an observational phase of 18–48 months. Two hundred participants were enrolled during three consecutive RSV seasons beginning in the fall of 2016 and were randomized to receive oral azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for an additional 7 days, or matched placebo. The study hypothesis is that in infants hospitalized with RSV bronchiolitis, the addition of azithromycin therapy to routine bronchiolitis care would reduce the likelihood of developing post-RSV recurrent wheeze (≥3 episodes). The primary clinical outcome is the occurrence of a third episode of wheezing, which is evaluated every other month by phone questionnaires and during yearly in-person visits. A secondary objective of the APW-RSV II clinical trial is to examine how azithromycin therapy changes the upper airway microbiome composition, and to determine if these changes are related to the occurrence of post-RSV RW. Microbiome composition is characterized in nasal wash samples obtained before and after the study treatments. This clinical trial may identify the first effective intervention applied during severe RSV bronchiolitis to reduce the risk of post-RSV RW and ultimately asthma.
AB - Severe respiratory syncytial virus (RSV) bronchiolitis in early life is a significant risk factor for future recurrent wheeze (RW) and asthma. The goal of the Azithromycin to Prevent Wheezing following severe RSV bronchiolitis II (APW-RSV II) clinical trial is to evaluate if azithromycin treatment in infants hospitalized with RSV bronchiolitis reduces the occurrence of RW during the preschool years. The APW-RSV II clinical trial is a double-blind, placebo-controlled, parallel-group, randomized trial, including otherwise healthy participants, ages 30 days-18 months, who are hospitalized due to RSV bronchiolitis. The study includes an active randomized treatment phase with azithromycin or placebo for 2 weeks, and an observational phase of 18–48 months. Two hundred participants were enrolled during three consecutive RSV seasons beginning in the fall of 2016 and were randomized to receive oral azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for an additional 7 days, or matched placebo. The study hypothesis is that in infants hospitalized with RSV bronchiolitis, the addition of azithromycin therapy to routine bronchiolitis care would reduce the likelihood of developing post-RSV recurrent wheeze (≥3 episodes). The primary clinical outcome is the occurrence of a third episode of wheezing, which is evaluated every other month by phone questionnaires and during yearly in-person visits. A secondary objective of the APW-RSV II clinical trial is to examine how azithromycin therapy changes the upper airway microbiome composition, and to determine if these changes are related to the occurrence of post-RSV RW. Microbiome composition is characterized in nasal wash samples obtained before and after the study treatments. This clinical trial may identify the first effective intervention applied during severe RSV bronchiolitis to reduce the risk of post-RSV RW and ultimately asthma.
KW - Asthma
KW - Azithromycin
KW - Microbiome
KW - Recurrent wheezing
KW - Respiratory syncytial virus (RSV) bronchiolitis
UR - http://www.scopus.com/inward/record.url?scp=85107903858&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2021.100798
DO - 10.1016/j.conctc.2021.100798
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C2 - 34189338
AN - SCOPUS:85107903858
SN - 2451-8654
VL - 22
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100798
ER -
