Inhaled Steroid Treatment as Regular Therapy in Early Asthma
START
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.
2 other identifiers
interventional
6,800
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Oct 1996
Longer than P75 for phase_4 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedMarch 25, 2009
March 1, 2009
6.3 years
March 18, 2008
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Related Publications (1)
O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31.
PMID: 18990678DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Romain Pauwels
Steering Committee Chairman
- STUDY CHAIR
William Busse
Steering Committee Chairman
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
October 1, 1996
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
March 25, 2009
Record last verified: 2009-03