Symbicort in Asthmatic Children - SEEDLING

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00651547
First received: April 1, 2008
Last updated: March 27, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years


Condition Intervention Phase
Asthma
Drug: budesonide/formoterol
Drug: budesonide
Drug: formoterol
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-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Morning PEF [ Time Frame: Daily ]

Secondary Outcome Measures:
  • Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments [ Time Frame: Throughout the treatment period ]

Estimated Enrollment: 405
Study Start Date: July 2002
Study Completion Date: October 2003
Arms Assigned Interventions
Experimental: 1 Drug: budesonide/formoterol
Other Name: Symbicort
Active Comparator: 2 Drug: budesonide
Active Comparator: 3 Drug: formoterol

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Baseline lung function tests results as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

  • Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
  • Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
  • Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study
  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: NCT00651547

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

No publications provided

ClinicalTrials.gov Identifier: NCT00651547     History of Changes
Other Study ID Numbers: SD-039-0718, D5896C00718
Study First Received: April 1, 2008
Last Updated: March 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Asthma
Symbicort
budesonide/formoterol
budesonide
formoterol
children

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

ClinicalTrials.gov processed this record on October 20, 2014