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Trial record 27 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646529
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 30, 2009
Information provided by:

Brief Summary:
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
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
Study Start Date : July 2002
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1
Drug: budesonide/formoterol (Symbicort)
Other Name: Symbicort

Active Comparator: 2
Drug: budesonide (Pulmicort)
Other Name: Pulmicort

Primary Outcome Measures :
  1. 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 :
  1. Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort [ Time Frame: 4 assessments within 26 week treatment period ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646529

Sponsors and Collaborators
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Study Director: Catherine Bonuccelli AstraZeneca

Layout table for additonal information Identifier: NCT00646529     History of Changes
Other Study ID Numbers: SD-039-0719
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
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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