Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases

Asthma Clinical Trial

— ACOS  

Official title:

Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02488590
• Other study ID #: S57767
• Status: Active, not recruiting
• 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
• 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..).

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Overlap Syndrome
• Pulmonary Disease, Chronic Obstructive
• Undifferentiated Connective Tissue Diseases

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