Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Asthma Overlap Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

LABA + LAMA

Intervention Type DRUG

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.

ASTHMA

patients with asthma and a normal spirometry

Clinical intervention: Inhaled corticosteroids (ICS)

ICS

Intervention Type DRUG

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.

ASTHMA COPD OVERLAP SYNDROME

patients with an obstructive spirometry and characteristics of both COPD and Asthma

Clinical Intervention: LABA + LAMA + ICS

LABA + LAMA + ICS

Intervention Type DRUG

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.

OBSTRUCTIVE ASTHMA

patients with an obstructive spirometry and characteristics of asthma

Clinical Intervention: LABA + ICS inhaled therapy

LABA + ICS

Intervention Type DRUG

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

patients with another diagnosis or healthy persons

clinical Intervention: undefined - according to diagnosis

other

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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dual bronchodilation inhaled cortiscosteroids triple therapy bronchodilator inhaled corticosteroid fixed combinations no inhalation therapy

Eligibility Criteria

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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..).

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No