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OpenTrials
Completed

NCT Number: NCT00646620

Symbicort Onset of Action 1

The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in 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

18 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 test results as determined by protocol
  • Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

Exclusion criteria

  • Severe asthma or asthma markedly affected by seasonal factors
  • 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

fluticasone/salmeterol (Advair Diskus)

Drug

Other names: Advair Diskus

albuterol (Ventolin)

Drug

Other names: Ventolin

Primary outcomes

  1. FEV1 3 minutes post dose

    Time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Secondary outcomes

  1. 12 hour serial FEV1

    Time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

  2. Patients perception of effect

    Time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.

Important dates

Study start
2003
Study completion
2003
First posted
Mar 28, 2008
Registry last updated
Apr 6, 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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