A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Daily Versus Weekly 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 Actuations Twice Daily

AstraZeneca1 site in 1 country123 target enrollmentMarch 2007

ConditionsAsthma

DrugsBudesonide/formoterol pMDI Budesonide HFA pMDI

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Asthma
Sponsor: AstraZeneca
Enrollment: 123
Locations: 1
Primary Endpoint: To demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) items 2 and 5 using a 1 week recall period versus a 1 day recall period.
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) using a 1 week recall period versus a 1 day recall period.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

August 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 demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) items 2 and 5 using a 1 week recall period versus a 1 day recall period.

Secondary Outcomes

To demonstrate the value to subjects of feeling an asthma maintenance medication begins to work right away; to assess the correlation between subject's responses to weekly/daily Onset of Effect Questionnaires with lung function and with diary variables.