Skip to content

Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00319306
Acronym
RELEASE
Enrollment
550
Registered
2006-04-27
Start date
2005-09-30
Completion date
2006-12-31
Last updated
2009-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Respiratory Tract Diseases, Bronchial Diseases, Anti-asthmatic agents, Anti-asthmatic drugs, Bronchodilators

Brief summary

The purpose of this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation.

Interventions

DRUGBudesonide/formoterol

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged over 18 * Confirmed diagnosis of mild to moderate asthma by doctor * Currently receiving inhaled corticoid-steroid medicine for treatment of asthma and requiring a review of current asthma treatment

Exclusion criteria

* Women who are pregnant, breast-feeding, or planning pregnancy * Patients with a history of chronic obstructive pulmonary disease * Patients using any beta blocker therapy * Patients receiving steroid tablets or steroid injections

Design outcomes

Primary

MeasureTime frame
In a real life setting, to compare Symbicort® Single Inhaler Therapy with a patient's previous therapy (including low dose ICS), by assessment of the changes in the Asthma Control Questionnaire score in uncontrolled asthmatic patients.

Secondary

MeasureTime frame
Change in forced expiratory volume in one second (FEV1)
Change in peak expiratory flow (PEF)
Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026