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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
budesonide
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Pulmicort, budesonide

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)

    Secondary Outcome Measures

    Pre-bronchodilator FEV1 % of predicted normal
    HE: Asthma related events and health care utilisation, and symptom free days (SFD)
    Post-bronchodilator FVC % of predicted

    Full Information

    First Posted
    March 18, 2008
    Last Updated
    March 24, 2009
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00641914
    Brief Title
    Inhaled Steroid Treatment as Regular Therapy in Early Asthma
    Acronym
    START
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1996 (undefined)
    Primary Completion Date
    February 2003 (Actual)
    Study Completion Date
    February 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma, Pulmicort, budesonide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    6800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    budesonide
    Other Intervention Name(s)
    Pulmicort
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)
    Time Frame
    At week 6 and12, and every 3 months thereafter
    Secondary Outcome Measure Information:
    Title
    Pre-bronchodilator FEV1 % of predicted normal
    Time Frame
    At week 6 and12, and every 3 months thereafter
    Title
    HE: Asthma related events and health care utilisation, and symptom free days (SFD)
    Time Frame
    At week 6 and12, and every 3 months thereafter
    Title
    Post-bronchodilator FVC % of predicted
    Time Frame
    At week 6 and12, and every 3 months thereafter

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Romain Pauwels
    Organizational Affiliation
    Steering Committee Chairman
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    William Busse
    Organizational Affiliation
    Steering Committee Chairman
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18990678
    Citation
    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. Erratum In: Am J Respir Crit Care Med. 2010 Oct 1;182(7):983-4.
    Results Reference
    derived

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    Inhaled Steroid Treatment as Regular Therapy in Early Asthma

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