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Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 26, 2008
Last updated: March 27, 2009
Last verified: March 2009
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol [ Time Frame: 4 assessments within 26 week treatment period ]

Secondary Outcome Measures:
  • Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort [ Time Frame: 4 assessments within 26 week treatment period ]

Estimated Enrollment: 175
Study Start Date: July 2002
Study Completion Date: October 2003
Arms Assigned Interventions
Experimental: 1
Drug: budesonide/formoterol (Symbicort)
Other Name: Symbicort
Active Comparator: 2
Drug: budesonide (Pulmicort)
Other Name: Pulmicort


Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 6 and maximally 11 years of age
  • Diagnosis of asthma
  • Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start

Exclusion Criteria:

  • Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
  • Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00646529

Sponsors and Collaborators
Study Director: Catherine Bonuccelli AstraZeneca
  More Information Identifier: NCT00646529     History of Changes
Other Study ID Numbers: SD-039-0719
Study First Received: March 26, 2008
Last Updated: March 27, 2009

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 21, 2017