Clinical trial NCT02488590: Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases
Official title: Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Asthma
Overlap Syndrome
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility 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..).

Primary outcomes:
measure: Accuracy of the proposed diagnostic algorithm
timeFrame: after work-up at inclusion (at baseline)
measure: Accuracy of the proposed diagnostic algorithm (at one year follow-up)
timeFrame: at one year
Secondary outcomes:
measure: Difference in ACT/CAT-scores
timeFrame: 3 months
measure: Difference in ACT/CAT-scores
timeFrame: 1 year
measure: Difference in Delta ACT/CAT scores (0 - 3 months)
timeFrame: 3 months
measure: Difference in Delta ACT/CAT scores (0 - 1 year)
timeFrame: 1 year
measure: specificity and sensitivity of individual criteria for final diagnosis
timeFrame: 1 year
measure: independency of criteria for final diagnosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
state: Vlaanderen
Study officials:
affiliation: KU Leuven
name: Wim Janssens, MD
role: PRINCIPAL_INVESTIGATOR
References: