Inhaled Steroid Treatment as Regular Therapy in Early Asthma

Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641914

Acronym

START

Enrollment

6800

Registered

2008-03-24

Start date

1996-10-31

Completion date

2003-02-28

Last updated

2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Pulmicort, budesonide

Brief summary

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.

Interventions

DRUGbudesonide

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)	At week 6 and12, and every 3 months thereafter

Secondary

Measure	Time frame
Pre-bronchodilator FEV1 % of predicted normal	At week 6 and12, and every 3 months thereafter
HE: Asthma related events and health care utilisation, and symptom free days (SFD)	At week 6 and12, and every 3 months thereafter
Post-bronchodilator FVC % of predicted	At week 6 and12, and every 3 months thereafter

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026