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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00641914
First received: March 18, 2008
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Asthma
Drug: budesonide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 6800
Study Start Date: October 1996
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: budesonide
Other Name: Pulmicort
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641914

Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Romain Pauwels Steering Committee Chairman
Study Chair: William Busse Steering Committee Chairman
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars-Göran Carlsson, AstraZeneca
ClinicalTrials.gov Identifier: NCT00641914     History of Changes
Other Study ID Numbers: SD-004-0111, D5254C00111
Study First Received: March 18, 2008
Last Updated: March 24, 2009
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Agency for Health and Food Safety
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Spain: Spanish Agency of Medicines
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Indonesia: National Agency of Drug and Food Control
Israel: Ministry of Health
Italy: Ministry of Health
Korea: Food and Drug Administration
Mexico: Ministry of Health
Malaysia: Ministry of Health
Norway: Norwegian Medicines Agency
Philippines: Bureau of Food and Drugs
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Sweden: Medical Products Agency
Singapore: Health Sciences Authority
Thailand: Food and Drug Administration
Taiwan: Department of Health
United States: Food and Drug Administration
South Africa: Department of Health

Keywords provided by AstraZeneca:
Asthma
Pulmicort
budesonide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014