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OpenTrials
Completed

NCT Number: NCT00652392

Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

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

16 year and older

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

  • Diagnosis of asthma and baseline lung function tests as determined by the protocol
  • 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 protocol or requires treatment with beta-blockers

Treatment and study plan

budesonide/formoterol

Drug

Other names: Symbicort

budesonide and placebo

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. Health-related quality of life

    Time frame: 4 assessments within 12 week treatment period

  3. Routine safety assessments

    Time frame: 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, Placebo and Active-controlled Study of Symbicort pMDI Administered Once Daily in Adults and Adolescents With Asthma - STEM

Important dates

Study start
2003
Study completion
2004
First posted
Apr 3, 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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