Table 3.
Selected Ongoing Clinical Trials in the Prevention of Asthma
| Trial Number | Study Design | Primary Outcome of Study |
|---|---|---|
| NCT0214879653 | Double-blind, RCT of Broncho-Vaxom vs placebo for 10 d/mo for 2 y in children 6-18 mo old at high risk of asthma. Followed by observation year. | Time to LRTI with wheeze in the third year of study. |
| NCT0257098410 | Double-blind RCT of omalizumab vs placebo every 4 wks for 2 y starting at 24-47 mo of age in wheezing children at high risk of asthma because of sensitization to aeroallergens. | Asthma diagnosis during the second of 2 y of observation. |
| NCT0262494758 | Observer-blind, RCT of RSV F vaccine vs placebo in 4,636 third-trimester pregnant women. Maternal subjects studied for ∼ 9 mo after the first dose and the infant studied for 1 y of life. | Incidence of significant RSV LRTI (hypoxia or tachypnea) in the first 90 d of life. Also evaluating wheeze in the first year. |
| NCT0287833058 | Double-blind, RCT evaluating MEDI8897, an anti-RSV monoclonal antibody with an extended half-life in healthy preterm infants. | Number of infants hospitalized with LRTI due to RSV. |
| NCT0291193511 | Double-blind RCT of children aged 1-18 mo hospitalized with RSV bronchiolitis and treated with azithromycin vs placebo × 2 wks and observed for up to 48 mo. | Occurrence of recurrent wheeze during preschool years. |
| U1111-1203-196164 | RCT of infants randomized to receive either exclusively paracetamol vs ibuprofen prn fever/pain in the first year of life and asthma rates evaluated. | Asthma diagnosis at age 6. |
LRTI = lower respiratory tract infection; RSV = respiratory syncytial virus. See Table 1 legend for expansion of other abbreviations.