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START: Inhaled Steroid Treatment as Regular Therapy in Early Asthma

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00641914
Collaborator
(none)
6,800
Enrollment
2
Arms
76
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Oct 1, 1996
Actual Primary Completion Date :
Feb 1, 2003
Actual Study Completion Date :
Feb 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: budesonide
Other Names:
  • Pulmicort

    		•
    Placebo Comparator: 2

    Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Pre-bronchodilator FEV1 % of predicted normal [At week 6 and12, and every 3 months thereafter]

    2. HE: Asthma related events and health care utilisation, and symptom free days (SFD) [At week 6 and12, and every 3 months thereafter]

    3. Post-bronchodilator FVC % of predicted [At week 6 and12, and every 3 months thereafter]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Chair: Romain Pauwels, Steering Committee Chairman
    • Study Chair: William Busse, Steering Committee Chairman

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00641914
    Other Study ID Numbers:
    • SD-004-0111
    • D5254C00111
    First Posted:
    Mar 24, 2008
    Last Update Posted:
    Mar 25, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    Asthma
    Pulmicort
    budesonide
    Additional relevant MeSH terms:
    Asthma
    Budesonide

    Study Results

    No Results Posted as of Mar 25, 2009