Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases

NCT02488590 | Unknown

• 1 other identifier: S57767
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma; Overlap Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Difference in ACT/CAT-scores

  3 months

• Difference in ACT/CAT-scores

  1 year

• Difference in Delta ACT/CAT scores (0 - 3 months)

  3 months

• Difference in Delta ACT/CAT scores (0 - 1 year)

  1 year

• specificity and sensitivity of individual criteria for final diagnosis

  1 year

Study Arms (5)

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

ASTHMA

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

Drug: ICS

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

OBSTRUCTIVE ASTHMA

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

Drug: LABA + ICS

OTHER

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

Drug: other

Interventions

LABA + LAMA 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.

Also known as: dual bronchodilation

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

ICS 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.

Also known as: inhaled cortiscosteroids

ASTHMA

LABA + LAMA + ICS 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.

Also known as: triple therapy

ASTHMA COPD OVERLAP SYNDROME

LABA + ICS 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.

Also known as: bronchodilator inhaled corticosteroid fixed combinations

OBSTRUCTIVE ASTHMA

other 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.

Also known as: no inhalation therapy

OTHER

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subjects with respiratory symptoms suggestive of chronic airway disease

You may not qualify if:

• 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..).

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Gasthuisberg

Leuven, Flanders, 3000, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

laminin A

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Wim Janssens, MD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Wim Janssens

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2021
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

BE (1)