Symbicort Onset of Action 1

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: albuterol (Ventolin); Drug: fluticasone/salmeterol (Advair Diskus); Drug: budesonide/formoterol (Symbicort)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646620

SD-039-0732

D5896C00732

Details and patient eligibility

About

The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of asthma and baseline lung function test results as determined by protocol
• Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

Exclusion criteria

• Severe asthma or asthma markedly affected by seasonal factors
• Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

48 participants in 3 patient groups

1

Experimental group

Description:

budesonide/formoterol

Treatment:

Drug: budesonide/formoterol (Symbicort)

2

Active Comparator group

Description:

fluticasone/salmeterol

Treatment:

Drug: fluticasone/salmeterol (Advair Diskus)

3

Active Comparator group

Description:

albuterol

Treatment:

Drug: albuterol (Ventolin)