Inhaled Steroid Treatment as Regular Therapy in Early Asthma

Asthma Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641914
• Other study ID #: SD-004-0111
• Secondary ID: D5254C00111
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: March 24, 2009
• Start date: October 1996
• Est. completion date: February 2003

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: Agency for Health and Food SafetyAustralia: National Health and Medical Research CouncilBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaChina: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencySpain: Spanish Agency of MedicinesFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyGreece: Ministry of Health and WelfareHungary: National Institute of PharmacyIndonesia: National Agency of Drug and Food ControlIsrael: Ministry of HealthItaly: Ministry of HealthKorea: Food and Drug AdministrationMexico: Ministry of HealthMalaysia: Ministry of HealthNorway: Norwegian Medicines AgencyPhilippines: Bureau of Food and DrugsPoland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSweden: Medical Products AgencySingapore: Health Sciences AuthorityThailand: Food and Drug AdministrationTaiwan: Department of HealthUnited States: Food and Drug AdministrationSouth Africa: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6800
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)		At week 6 and12, and every 3 months thereafter
Secondary	Pre-bronchodilator FEV1 % of predicted normal		At week 6 and12, and every 3 months thereafter
Secondary	HE: Asthma related events and health care utilisation, and symptom free days (SFD)		At week 6 and12, and every 3 months thereafter
Secondary	Post-bronchodilator FVC % of predicted		At week 6 and12, and every 3 months thereafter