A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Act. Twice Daily

AstraZeneca1 site in 1 country134 target enrollmentMarch 2007

ConditionsAsthma

DrugsBudesonide/formoterol pMDI Budesonide HFA pMDI

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Asthma
Sponsor: AstraZeneca
Enrollment: 134
Locations: 1
Primary Endpoint: To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

November 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Male or Female, \> 18 years of age
•Mild to moderate asthma requiring treatment with an inhaled corticosteroid
•Diagnosis of asthma for at least 6 months

Exclusion Criteria

•Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
•Subjects with severe asthma, as judged by investigator
•Any significant disease or disorder that may jeopardize a subject's safety

Outcomes

Primary Outcomes

To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group

Secondary Outcomes

To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away