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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00652392
First received: April 1, 2008
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Asthma
Drug: budesonide/formoterol
Drug: budesonide and placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in evening PEF [ Time Frame: Daily throughout the 12 week treatment period ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 750
Study Start Date: April 2003
Study Completion Date: June 2004
Arms Assigned Interventions
Experimental: 1 Drug: budesonide/formoterol
Other Name: Symbicort
Placebo Comparator: 2 Drug: budesonide and placebo

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652392

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Bonuccelli AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00652392     History of Changes
Other Study ID Numbers: SD-039-0726, D5896C00726
Study First Received: April 1, 2008
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
asthma
adolescents
adults
Symbicort
budesonide/formoterol
budesonide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014