Adults With Moderate to Severe Asthma

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642122

SD-004-0764

D5257L00012

Details and patient eligibility

About

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

Enrollment: 900 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 12 or over who have asthma
• Ability to properly use an electronic diary
• Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion criteria

• Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
• Planned hospitalisation during the study
• pregnant women or women planning to become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 2 patient groups

1

Experimental group

Description:

Pulmicort RESPULES

Treatment:

Drug: Budesonide

Drug: Budesonide

Drug: Budesonide

Drug: Budesonide

Drug: Budesonide

2

Experimental group

Description:

Pulmicort TURBUHALER

Treatment:

Drug: Budesonide

Drug: Budesonide

Drug: Budesonide

Drug: Budesonide

Drug: Budesonide