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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide HFA pMDI; Drug: Budesonide/formoterol pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449501

D5896C00025

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind