SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Budesonide/formoterol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00290264

D5890L00009

SALTO

Eudract No: 2004-001107-36

Details and patient eligibility

About

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition.
Prescribed inhaled GCS at a dose of ≥320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.

Exclusion criteria

Use of any b-blocking agent, including eye-drops.
Use of oral GCS as maintenance treatment.
Known or suspected hypersensitivity to study therapy or excipients.
A history of smoking ≥ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).