CFDB - Cystic Fibrosis DataBase

  1. Home
  2. Database
Search (?)
at least one term
all terms
Advanced search
primary studies published RCT

The effect of oxygen on sleep, blood gases, and ventilation in cystic fibrosis.

  • Year: 1984
  • Date: 1991
  • Author: Spier S
Source

American Review of Respiratory Disease YR: 1984 VL: 129 DE: RCT NO: 5

Study design (if review, criteria of inclusion for studies)

RCT

Participants

49 CF children aged 2 to 8 years were followed for 12 months. The RU-41740 patients (n = 25) were older, taller and more ill (lower Shwachmann score) than the control group (n = 24)

Interventions

RU-41740 ('Biostim') and placebo used against recurrent respiratory infections

Outcome measures

URT infections, infection time, duration of antibiotic treatment, clinical and laboratory tolerability

Main results

the RU-41740 group had significantly fewer URT infections (2.16) than the placebo group (3.63) over the 12 months (p = 0.05). The total infection time was shorter (17.12 vs 25.54 days, p = 0.12) and the duration of antibiotic treatment significantly shorter (12.28 vs 23.5 days, p = 0.03). The clinical (particularly gastrointestinal) and laboratory tolerability of RU-41740 were good. RU-41740 provided prophylactic treatment against URT infections in these cystic fibrosis patients in whom infection is a serious threat.

Authors' conclusions

Further investigations with this drug are warranted.

Keywords: Child; placebo; RU-41740 -Biostim-; Respiratory Tract Infections; Respiratory Tract Diseases; Infection; Immunoregulatory; pharmacological_intervention;