- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01360294
Development of Small Airway Disease Questionnaire (SADQ)
June 27, 2013 updated by: E. van der Wiel, University Medical Center Groningen
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9700RB
- University Medical Center Groningen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Asthma with small airway disease
|
Asthma without small airway disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
May 12, 2011
First Submitted That Met QC Criteria
May 23, 2011
First Posted (Estimate)
May 25, 2011
Study Record Updates
Last Update Posted (Estimate)
June 28, 2013
Last Update Submitted That Met QC Criteria
June 27, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SADQ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany