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Completed

NCT Number: NCT00646529

Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

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

Completed

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide/formoterol (Symbicort)

Drug

Other names: Symbicort

budesonide (Pulmicort)

Drug

Other names: Pulmicort

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2003
First posted
Mar 28, 2008
Registry last updated
Mar 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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