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Completed

NCT Number: NCT01360294

Development of Small Airway Disease Questionnaire

The aim of this study is to develop a patient reported outcome tool specific to small airways disease, which assesses symptoms and signs of small airways disease and may help in addition to FEF50% to discriminate between asthmatic patients with and without small airways disease.

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Key information

About this study

Inflammation of the small airways contributes to the severity of the disease and affects the quality of life of patients with asthma. However, the exact role and relevance of small airways disease in asthma is still unclear. This is partly due to the difficulty of measuring small airways pathology with a sensitive and specific parameter. The most commonly used variable as an indicator of small airway obstruction is the FEF50%. Currently, it is not known which clinical symptoms are associated with small airways disease and how a patient will perceive small airway abnormalities. This knowledge is important to assess small airways disease in patients with asthma and adjust therapy to improve quality of life.The primary purpose of this study is to develop a questionnaire for patients with asthma with and without small airways disease for general and specialist practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A doctor diagnosis of asthma
  • Age: ≥ 18 and ≤ 75 years
  • An FEF50% value that is included in either the lowest or the highest 25th percentile. (Percentiles based on the total asthma patient group present from Asthma/COPD service)

Exclusion criteria

  • Recent exacerbation of asthma (<2 months) or upper respiration tract infection (<2 weeks)
  • Severe airway obstruction at baseline, FEV1pred< 50% or < 1.2L
  • Diagnosis of COPD or another pulmonary disease
  • Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator).
  • Restriction, defined as FVC < 80%pred with FEV1/FVC >0.7

Treatment and study plan

Primary outcomes

  1. Symptoms associated with small airways disease

    Time frame: 1 year

    A questionnaire based on symptoms to discriminate between asthmatic patients with and without small airways disease.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

The Development of a Questionnaire to Assess Symptoms of Small Airways Disease in Patients With Asthma

Acronym: SADQ

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 25, 2011
Registry last updated
Jun 28, 2013

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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