Experience using centralized spirometry in the phase 2 randomized, placebo-controlled, double-blind trial of denufosol in patients with mild to moderate cystic fibrosis.
Study design (if review, criteria of inclusion for studies)
phase 2 randomized, placebo-controlled, double-blind clinical trial of denufosol in patients with mild to moderate CF
Participants
n=89; spirometries=1418
Interventions
spirometry
Outcome measures
Uniform spirometers were used with electronic data transmission of all the data to a reading center. Spirometry was evaluated for quality by a central reader based on start of test, cough during the test, and evidence of a plateau.
Main results
In only 5 instances did the central reading center need to give feedback to sites regarding the quality of spirometry. The study site data matched the central reading center's data for all but 78 (6%) spirometry values in 33 patients. Many of these differences were small with only 35 (3%) values differing by more than 50 mL in 26 patients.
Authors' conclusions
Spirometry in this clinical trial was of high quality with low rate of significant centralized over-read.
Keywords: Adolescent; Other drugs; denufosol; Inhalation OR nebulised; pharmacological_intervention; placebo;