Titratable Dosing in Moderate to Severe Asthmatics

Condition(s) targeted: Asthma

Intervention: budesonide/formoterol (Drug); Symbicort pMDI + budesonide HFA pMDI (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Catherine Bonuccelli, Study Director, Affiliation: AstraZeneca

The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

Official title: A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study

Primary outcome: Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.

Secondary outcome:

To measure changes in lung function tests, patient reported outcomes and usage of medical resource

Blood levels of budesonide and formoterol

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of asthma and baseline lung function tests, symptoms and medication use as

determined by the protocol

- Required and received treatment with inhaled corticosteroids within the timeframe and

doses specified in the protocol

Exclusion Criteria:

- Has required treatment with non-inhaled corticosteroids within previous 30 days, has

sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.

- Has had cancer within previous 5 years or has a condition that may put the patient at

risk in this study.

Starting date: August 2003
Ending date: May 2005
Last updated: April 2, 2008