Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM
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ClinicalTrials.gov Identifier: NCT00652392 |
Recruitment Status :
Completed
First Posted : April 3, 2008
Last Update Posted : January 24, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: budesonide/formoterol Drug: budesonide and placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 750 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2003 |
Actual Study Completion Date : | June 2004 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: budesonide/formoterol
Other Name: Symbicort |
Placebo Comparator: 2 |
Drug: budesonide and placebo |
- Change in evening PEF [ Time Frame: Daily throughout the 12 week treatment period ]
- Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes [ Time Frame: Daily throughout the 12 week treatment period ]
- Health-related quality of life [ Time Frame: 4 assessments within 12 week treatment period ]
- Routine safety assessments [ Time Frame: 4 assessments within 12 week treatment period ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652392
Study Director: | Catherine Bonuccelli | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00652392 |
Other Study ID Numbers: |
SD-039-0726 D5896C00726 |
First Posted: | April 3, 2008 Key Record Dates |
Last Update Posted: | January 24, 2011 |
Last Verified: | January 2011 |
asthma adolescents adults |
Symbicort budesonide/formoterol budesonide |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Formoterol Fumarate Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |