A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects

Phase 3 Completed 134 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.

Timeline

Start: 2007-03
Primary completion: —
Completion: 2007-11

Outcome

Missed primary endpoint

paper No significant differences were observed in patients' reports of perception, either daily versus weekly or predose versus postdose. PMID 19995138 ↗

Publications

Leidy NK, Gutierrez B, Lampl K, Uryniak T, O'Brien CD. Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception. J Asthma. 2009 Dec;46(10):1006-12. doi: 10.3109/02770900903301260.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	160 ug	Inhaled
Subject	Formoterol	Other / unclassified	9 ug	Inhaled