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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
Definition of endpoints
Physician based diagnosis:
diagnosis based on clinical exam and spirometry
Algorithm based diagnosis:
diagnosis based on clinical exam and test battery
Final standard diagnosis diagnosis based on clinical exam, test battery and clinical evolution of 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Patients with an obstructive spirometry and characteristics of chronic obstructive pulmonary disease Clinical intervention: Long acting B agonist (LABA) + Long acting muscarinic receptor antagonist (LAMA) inhaled therapy |
| |
| ASTHMA | patients with asthma and a normal spirometry Clinical intervention: Inhaled corticosteroids (ICS) |
| |
| ASTHMA COPD OVERLAP SYNDROME | patients with an obstructive spirometry and characteristics of both COPD and Asthma Clinical Intervention: LABA + LAMA + ICS |
| |
| OBSTRUCTIVE ASTHMA | patients with an obstructive spirometry and characteristics of asthma Clinical Intervention: LABA + ICS inhaled therapy |
| |
| OTHER | patients with another diagnosis or healthy persons clinical Intervention: undefined - according to diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LABA + LAMA | Drug | An open label inhaled therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the proposed diagnostic algorithm | % changes of algorithm diagnosis compared to physician based diagnosis (based on spirometry only) | after work-up at inclusion (at baseline) |
| Accuracy of the proposed diagnostic algorithm (at one year follow-up) | % changes of algorithm diagnosis compared to final diagnosis (based on all tests with clinical evolution for 1 year)) | at one year |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in ACT/CAT-scores | Difference of ACT/CAT-score between arms at 3 months | 3 months |
| Difference in ACT/CAT-scores | Difference of ACT/CAT-scores between arms at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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All patients of Caucasian descent, ageing 30-80 years and presenting for the first time at the outpatient pulmonary clinic of the University Hospitals Leuven with respiratory symptoms
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| Name | Affiliation | Role |
|---|---|---|
| Wim Janssens, MD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gasthuisberg | Leuven | Flanders | 3000 | Belgium |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C084098 | laminin A |
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|
|
| ICS | Drug | An open label inhaled therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up. |
|
|
| LABA + LAMA + ICS | Drug | An open label inhaled therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up. |
|
|
| LABA + ICS | Drug | An open label inhaled therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up. |
|
|
| other | Drug | An open label therapy or no therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up. |
|
|
| 1 year |
| Difference in Delta ACT/CAT scores (0 - 3 months) | Difference of delta ACT/CAT-scores (0 - 3 months) between arms | 3 months |
| Difference in Delta ACT/CAT scores (0 - 1 year) | Difference of delta ACT/CAT-scores (0 - 1 year) between arms | 1 year |
| specificity and sensitivity of individual criteria for final diagnosis | ROC curve analysis for individual criteria in predicting final diagnosis | 1 year |
| independency of criteria for final diagnosis | Logistic regression analysis for criteria in predicting final diagnosis | 1 year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |