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Development of Small Airway Disease Questionnaire (SADQ)

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ClinicalTrials.gov Identifier: NCT01360294
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
E. van der Wiel, University Medical Centre Groningen

Brief Summary:
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.

Condition or disease
Asthma

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 65 participants
Time Perspective: Prospective
Official Title: The Development of a Questionnaire to Assess Symptoms of Small Airways Disease in Patients With Asthma
Study Start Date : September 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma COPD
U.S. FDA Resources

Group/Cohort
Asthma with small airway disease
Asthma without small airway disease



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360294


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
Chiesi Farmaceutici S.p.A.

Responsible Party: E. van der Wiel, MD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01360294     History of Changes
Other Study ID Numbers: SADQ
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013

Keywords provided by E. van der Wiel, University Medical Centre Groningen:
Asthma
Small airways disease
Questionnaire

Additional relevant MeSH terms:
Asthma
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases