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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Overlap Syndrome
• Intervention / Treatment: Drug: LABA + LAMA; Drug: ICS; Drug: LABA + LAMA + ICS; Drug: LABA + ICS; Drug: other

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.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Belgium
  • Vlaanderen
    • Leuven, Vlaanderen, Belgium, 3000
      • Uz Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CHRONIC OBSTRUCTIVE PULMONARY DISEASE; 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	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.; Other Names: dual bronchodilation
ASTHMA; patients with asthma and a normal spirometry Clinical intervention: Inhaled corticosteroids (ICS)	Drug: 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 Names: inhaled cortiscosteroids
ASTHMA COPD OVERLAP SYNDROME; patients with an obstructive spirometry and characteristics of both COPD and Asthma Clinical Intervention: LABA + LAMA + ICS	Drug: 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.; Other Names: triple therapy
OBSTRUCTIVE ASTHMA; patients with an obstructive spirometry and characteristics of asthma Clinical Intervention: LABA + ICS inhaled therapy	Drug: 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 Names: bronchodilator inhaled corticosteroid fixed combinations
OTHER; patients with another diagnosis or healthy persons clinical Intervention: undefined - according to diagnosis	Drug: 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.; Other Names: no inhalation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Wim Janssens, MD, KU Leuven

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): April 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Bronchodilator Agents
• Other Study ID Numbers: S57767