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Development of Small Airway Disease Questionnaire (SADQ)

This study has been completed.
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
E. van der Wiel, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01360294
First received: May 12, 2011
Last updated: June 27, 2013
Last verified: June 2013

May 12, 2011
June 27, 2013
September 2011
August 2012   (final data collection date for primary outcome measure)
Symptoms associated with small airways disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
A questionnaire based on symptoms to discriminate between asthmatic patients with and without small airways disease.
Same as current
Complete list of historical versions of study NCT01360294 on ClinicalTrials.gov Archive Site
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Development of Small Airway Disease Questionnaire
The Development of a Questionnaire to Assess Symptoms of Small Airways Disease in Patients With Asthma

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.

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.

Observational
Time Perspective: Prospective
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Probability Sample

The study population will contain a total of 60 adult patients with asthma, 30 patients with small airways disease and 30 patients without small airways disease.

Asthma
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  • Asthma with small airway disease
  • Asthma without small airway disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01360294
SADQ
No
E. van der Wiel, University Medical Centre Groningen
University Medical Centre Groningen
Chiesi Farmaceutici S.p.A.
Not Provided
University Medical Centre Groningen
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP