Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00646529
First received: March 26, 2008
Last updated: March 27, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
budesonide/formoterol
Drug: budesonide/formoterol (Symbicort)
Other Name: Symbicort
Active Comparator: 2
budesonide
Drug: budesonide (Pulmicort)
Other Name: Pulmicort

  Eligibility

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

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
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: NCT00646529

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

No publications provided

ClinicalTrials.gov Identifier: NCT00646529     History of Changes
Other Study ID Numbers: SD-039-0719, D5896C00719
Study First Received: March 26, 2008
Last Updated: March 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
asthma
children
Symbicort
budesonide/formoterol
Pulmicort
budesonide

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

ClinicalTrials.gov processed this record on September 18, 2014