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The differential diagnosis of asthma and COPD is sometimes difficult. Recently, an overlap syndrome has been defined based on the concurrence of asthma and COPD characteristics. These characteristics are based on expert opinions and have never been investigated nor validated prospectively. The investigators assume that the management strategy, the symptom burden and disease progression will differ between asthma, COPD and ACOS. Therefore, the study wants to establish baseline criteria for an appropriate disease definition and evaluate the potential impact on treatment and symptom control.
This study aims to test a diagnostic algorithm for obstructive airways diseases that may be used in daily practice to obtain a correct differential diagnosis and, hence, initiate an adequate therapy according to the current guidelines. The proposed algorithm will be used to categorize patients in 4 different diagnoses with specific treatment choices: asthma, obstructive asthma, overlap asthma with COPD, and COPD. The study will evaluate which tests and criteria contribute most to the diagnostic work-up and final diagnosis. Test battery for diagnosis * spirometry with bronchodilator reversibility testing * bodyplethysmography: spirometry, volumes, resistance, diffusing capacity * exhaled NO * blood sample * CT scan of thorax (only when obstructive spirometry) * histamine challenge (only when spirometry is not obstructive) * induced sputum (not for protocol interpretation) Definition of endpoints 1. Physician based diagnosis: diagnosis based on clinical exam and spirometry 2. Algorithm based diagnosis: diagnosis based on clinical exam and test battery 3. Final standard diagnosis diagnosis based on clinical exam, test battery and clinical evolution of 1 year.
Age
30 - 80 years
Sex
ALL
Healthy Volunteers
No
UZ Gasthuisberg
Leuven, Flanders, Belgium
Start Date
July 1, 2015
Primary Completion Date
April 1, 2020
Completion Date
July 1, 2021
Last Updated
April 8, 2020
180
ACTUAL participants
LABA + LAMA
DRUG
ICS
DRUG
LABA + LAMA + ICS
DRUG
LABA + ICS
DRUG
other
DRUG
Lead Sponsor
KU Leuven
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07219173