Asthma Clinical Trial
Official title:
Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases
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.
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