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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02488590
Date of registration: 29/06/2015
Prospective Registration: Yes
Primary sponsor: KU Leuven
Public title: Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases ACOS
Scientific title: Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases
Date of first enrolment: July 2015
Target sample size: 180
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02488590
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Belgium
Contacts
Name:     Wim Janssens, MD
Address: 
Telephone:
Email:
Affiliation:  KU Leuven
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with respiratory symptoms suggestive of chronic airway disease

Exclusion Criteria:

- Subjects with an immediate need for hospitalization or a treatment of systemic
glucocorticoid or long-term antibiotics

- Subjects with pregnancy

- Subjects with clinically significant cardiovascular disease that warrants intervention

- Subject with concomitant pulmonary diseases (pulmonary embolism, interstitial lung
disease etc..).



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Overlap Syndrome
Asthma
Chronic Obstructive Pulmonary Disease
Intervention(s)
Drug: ICS
Drug: LABA + LAMA
Drug: other
Drug: LABA + LAMA + ICS
Drug: LABA + ICS
Primary Outcome(s)
Accuracy of the proposed diagnostic algorithm [Time Frame: after work-up at inclusion (at baseline)]
Accuracy of the proposed diagnostic algorithm (at one year follow-up) [Time Frame: at one year]
Secondary Outcome(s)
specificity and sensitivity of individual criteria for final diagnosis [Time Frame: 1 year]
independency of criteria for final diagnosis [Time Frame: 1 year]
Difference in Delta ACT/CAT scores (0 - 1 year) [Time Frame: 1 year]
Difference in ACT/CAT-scores [Time Frame: 3 months]
Difference in ACT/CAT-scores [Time Frame: 1 year]
Difference in Delta ACT/CAT scores (0 - 3 months) [Time Frame: 3 months]
Secondary ID(s)
S57767
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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