drugset / Trial / NCT02318043

AMP-BPT and His-BPT for Assessment of Asthma

NCT02318043

RandomizedCrossoverOpen-labelDiagnostic

Summary

Adenosine monophosphate (AMP) may reflect airway inflammation and hyperresponsiveness, but relationship between AMP and histamine (His, a conventional stimulus) bronchial provocation test (BPT) in asthma is not fully elucidated. The investigators aimed to compare both BPTs and determine their usefulness in reflecting changes of asthmatic symptoms. BPTs were performed in cross-over fashion, at 2-4day intervals. Cumulative doses eliciting 20% FEV1fall (PD20FEV1), diagnostic performance and adverse events were compared. Patients with PD20FEV1 lower than geometric mean were defined as responders, otherwise poor responders. Patients with uncontrolled and partly controlled asthma, who maintained their original inhaled corticosteroids therapy, underwent reassessment of airway responsiveness and asthmatic symptoms 3 and 6 months after.

Timeline

Start
2007-01
Primary completion
2007-12
Completion
2007-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 160 ug Inhaled
Comparator Fluticasone Other / unclassified 250 ug Inhaled
Comparator Salmeterol Other / unclassified 50 ug Inhaled
Comparator fomorterol Unknown 4.5 ug Inhaled

Indications