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

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ClinicalTrials.gov Identifier: NCT00641914
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
AstraZeneca

Study Description
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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
Asthma Drug: budesonide Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1996
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: budesonide
Other Name: Pulmicort
Placebo Comparator: 2 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Pre-bronchodilator FEV1 % of predicted normal [ Time Frame: At week 6 and12, and every 3 months thereafter ]
  2. HE: Asthma related events and health care utilisation, and symptom free days (SFD) [ Time Frame: At week 6 and12, and every 3 months thereafter ]
  3. Post-bronchodilator FVC % of predicted [ Time Frame: At week 6 and12, and every 3 months thereafter ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641914


Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Romain Pauwels Steering Committee Chairman
Study Chair: William Busse Steering Committee Chairman
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lars-Göran Carlsson, AstraZeneca
ClinicalTrials.gov Identifier: NCT00641914    
Other Study ID Numbers: SD-004-0111
D5254C00111
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Asthma
Pulmicort
budesonide
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
 Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists