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Completed

NCT Number: NCT00449527

A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects

The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) using a 1 week recall period versus a 1 day recall period.

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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

Primary location

Research Site, Tuscumbia, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or Female, > 18 years of age
  • Mild to moderate asthma requiring treatment with an inhaled corticosteroid
  • Diagnosis of asthma for at least 6 months

Exclusion criteria

  • Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
  • Subjects with severe asthma, as judged by investigator
  • Any significant disease or disorder that may jeopardize a subject's safety

Treatment and study plan

Budesonide/formoterol pMDI

Drug

Other names: Symbicort

Budesonide HFA pMDI

Drug

Primary outcomes

  1. To demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) items 2 and 5 using a 1 week recall period versus a 1 day recall period.

Secondary outcomes

  1. To demonstrate the value to subjects of feeling an asthma maintenance medication begins to work right away; to assess the correlation between subject's responses to weekly/daily Onset of Effect Questionnaires with lung function and with diary variables.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Daily Versus Weekly in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Actuations Twice Daily

Important dates

Study start
2007
Study completion
2007
First posted
Mar 20, 2007
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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