Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: budesonide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641914

SD-004-0111

D5254C00111

Details and patient eligibility

About

A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.

Enrollment: 6,800 estimated patients

Sex: All

Ages: 6 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged between 6 and 60 years
• diagnosed with asthma within 2 years of starting the study
• Ability to use a Turbuhaler

Exclusion criteria

• Symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study
• A history of the use of treatments like Pulmicort for more than 30 days per year in the two years before starting the study
• Regular daily treatment for asthma for more than two years before starting the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,800 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: budesonide

2

Placebo Comparator group

Treatment:

Drug: Placebo