Inhaled Steroid Treatment as Regular Therapy in Early Asthma - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00641914

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 IV

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
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.

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:	April 2003
Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: budesonide
2: Placebo Comparator	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

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

Publications indexed to this study:

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. Epub 2008 Oct 31.

Responsible Party:	AstraZeneca ( Lars-Göran Carlsson )
Study ID Numbers:	SD-004-0111, D5254C00111
Study First Received:	March 18, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00641914
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: State 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: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Budesonide
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009