Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases (ACOS)

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Asthma; Overlap Syndrome; Chronic Obstructive Pulmonary Disease

Treatments: Drug: LABA + LAMA; Drug: LABA + LAMA + ICS; Drug: other; Drug: ICS; Drug: LABA + ICS

Study type: Observational

Funder types: Other

Identifiers

NCT02488590

S57767

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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..).

Trial design

180 participants in 5 patient groups

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Description:

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

Treatment:

Drug: LABA + LAMA

ASTHMA

Description:

patients with asthma and a normal spirometry Clinical intervention: Inhaled corticosteroids (ICS)

Treatment:

Drug: ICS

ASTHMA COPD OVERLAP SYNDROME

Description:

patients with an obstructive spirometry and characteristics of both COPD and Asthma Clinical Intervention: LABA + LAMA + ICS

Treatment:

Drug: LABA + LAMA + ICS

OBSTRUCTIVE ASTHMA

Description:

patients with an obstructive spirometry and characteristics of asthma Clinical Intervention: LABA + ICS inhaled therapy

Treatment:

Drug: LABA + ICS

OTHER

Description:

patients with another diagnosis or healthy persons clinical Intervention: undefined - according to diagnosis

Treatment:

Drug: other