Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Asthma

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

December 1 2004

Trial Type :

INTERVENTIONAL

End Date :

August 1 2006

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT00290264

Start Date

December 1 2004

End Date

August 1 2006

Last Update

January 24 2011

Active Locations (209)

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Page 1 of 53 (209 locations)

1

Research Site

Aalst, Belgium

2

Research Site

Aartrijke, Belgium

3

Research Site

Alsemberg, Belgium

4

Research Site

Anderlecht, Belgium