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OpenTrials
Completed

NCT Number: NCT00651768

Titratable Dosing in Moderate to Severe Asthmatics

The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

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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

12 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, symptoms and medication use as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion criteria

  • Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
  • Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.

Treatment and study plan

budesonide/formoterol

Drug

Other names: Symbicort

Symbicort pMDI + budesonide HFA pMDI

Drug

Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg

Primary outcomes

  1. Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.

    Time frame: 7 assessments within 12 month treatment period

Secondary outcomes

  1. To measure changes in lung function tests, patient reported outcomes and usage of medical resource

    Time frame: 7 assessments within 12 month treatment period

  2. Blood levels of budesonide and formoterol

    Time frame: 10 blood samples taken at 1 visit in a sub-set of patients

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma

Important dates

Study start
2003
Study completion
2005
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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