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OpenTrials
Completed

NCT Number: NCT00646321

Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT

The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years

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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–15 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 15 years of age
  • Diagnosis of asthma and baseline lung function tests as determined by the protocol
  • Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion criteria

  • Severe asthma
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Treatment and study plan

budesonide/formoterol (Symbicort)

Drug

Other names: Symbicort

Budesonide

Drug

Primary outcomes

  1. Change in evening PEF

    Time frame: Daily throughout the 12 week treatment period

Secondary outcomes

  1. Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes

    Time frame: Daily throughout the 12 week treatment period

  2. Routine safety assessments described in the protocol

    Time frame: 2-4 assessments within 12 week treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT

Important dates

Study start
2003
Study completion
2004
First posted
Mar 28, 2008
Registry last updated
Jan 24, 2011

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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