Who is sponsoring NCT00385593?

NCT00385593 is sponsored by AstraZeneca.

What condition does NCT00385593 study?

NCT00385593 studies Asthma, Bronchial.

What drugs are being tested in NCT00385593?

Interventions: Symbicort (budesonide/formoterol) Turbuhaler, Conventional treatment.

What is the status of NCT00385593?

NCT00385593 is currently TERMINATED.

Last reviewed 2010-11-30 · How we verify

A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN

NCT00385593 Phase 3 TERMINATED Results posted

This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	TERMINATED
Enrolment	654
Start date	2006-09
Completion	2008-10

Conditions

Asthma, Bronchial

Interventions

Symbicort (budesonide/formoterol) Turbuhaler
Conventional treatment

Primary outcomes

Time to First Severe Asthma Exacerbation — Baseline up to 6 months
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.

Countries

Spain