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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02488590
Other study ID # S57767
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2015
Est. completion date July 2021

Study information

Verified date April 2020
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date July 2021
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility 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..).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LABA + LAMA
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.
ICS
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
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
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
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.

Locations

Country Name City State
Belgium UZ Gasthuisberg Leuven Vlaanderen

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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
Secondary Difference in ACT/CAT-scores Difference of ACT/CAT-score between arms at 3 months 3 months
Secondary Difference in ACT/CAT-scores Difference of ACT/CAT-scores between arms at 1 year 1 year
Secondary Difference in Delta ACT/CAT scores (0 - 3 months) Difference of delta ACT/CAT-scores (0 - 3 months) between arms 3 months
Secondary Difference in Delta ACT/CAT scores (0 - 1 year) Difference of delta ACT/CAT-scores (0 - 1 year) between arms 1 year
Secondary specificity and sensitivity of individual criteria for final diagnosis ROC curve analysis for individual criteria in predicting final diagnosis 1 year
Secondary independency of criteria for final diagnosis Logistic regression analysis for criteria in predicting final diagnosis 1 year
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