Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00646321
First received: March 26, 2008
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years


Condition Intervention Phase
Asthma
Drug: budesonide/formoterol (Symbicort)
Drug: budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT

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 ]
  • Routine safety assessments described in the protocol [ Time Frame: 2-4 assessments within 12 week treatment period ]

Estimated Enrollment: 540
Study Start Date: April 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Experimental: 1
budesonide/formoterol
Drug: budesonide/formoterol (Symbicort)
Other Name: Symbicort
Active Comparator: 2
budesonide
Drug: budesonide

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 6 and maximally 15 years of age
  • Diagnosis of asthma and baseline lung function tests as determined by the protocol
  • Has 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 the protocol or requires treatment with beta-blockers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646321

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: NCT00646321     History of Changes
Other Study ID Numbers: SD-039-0725, D5896C00725
Study First Received: March 26, 2008
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
asthma
children
adolescents
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 July 22, 2014