Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00641914
First received: March 18, 2008
Last updated: March 24, 2009
Last verified: March 2009
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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 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013