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Development of Small Airway Disease Questionnaire (SADQ)

This study is currently recruiting participants.
Verified September 2011 by University Medical Centre Groningen
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: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

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
Asthma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Development of a Questionnaire to Assess Symptoms of Small Airways Disease in Patients With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthma with small airway disease
Asthma without small airway disease

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360294

Contacts
Contact: Erica van der Wiel, MD +31 05 3619194 e.van.der.wiel@long.umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700RB
Principal Investigator: Erica van der Wiel, MD            
Sponsors and Collaborators
University Medical Centre Groningen
Chiesi Farmaceutici S.p.A.
  More Information

No publications provided

Responsible Party: E. van der Wiel, MD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01360294     History of Changes
Other Study ID Numbers: SADQ
Study First Received: May 12, 2011
Last Updated: September 14, 2011
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013