Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

A 12 Week, Randomized, Double-Blind, Double-Dummy, Placebo and Active-controlled Study of Symbicort pMDI Administered Once Daily in Adults and Adolescents With Asthma - STEM

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00652392

Enrollment

750

Registered

2008-04-03

Start date

2003-04-30

Completion date

2004-06-30

Last updated

2011-01-24

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

Conditions

Asthma

Keywords

asthma, adolescents, adults, Symbicort, budesonide/formoterol, budesonide

Brief summary

The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

Interventions

DRUGbudesonide/formoterol

DRUGbudesonide and placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of asthma and baseline lung function tests as determined by the protocol * Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion criteria

* Severe asthma * Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Design outcomes

Primary

Measure	Time frame
Change in evening PEF	Daily throughout the 12 week treatment period

Secondary

Measure	Time frame
Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes	Daily throughout the 12 week treatment period
Health-related quality of life	4 assessments within 12 week treatment period
Routine safety assessments	4 assessments within 12 week treatment period

Outcome results

None listed

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