Chronic Obstructive Pulmonary DiseaseACOSNCT02488590
Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma, Overlap Syndrome
- What is being tested?
- LABA + LAMA, ICS and LABA + LAMA + ICS
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2015to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Subjects with respiratory symptoms suggestive of chronic airway disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Physician based diagnosis: diagnosis based on clinical exam and spirometry
- Algorithm based diagnosis: diagnosis based on clinical exam and test battery
- Final standard diagnosis diagnosis based on clinical exam, test battery and clinical evolution of 1 year.
- Being tested
- LABA + LAMA, ICS, LABA + LAMA + ICS, LABA + ICS, other
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LABA + LAMADrug
Also called dual bronchodilation
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.
ICSDrug
Also called inhaled cortiscosteroids
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.
LABA + LAMA + ICSDrug
Also called triple therapy
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.
LABA + ICSDrug
Also called bronchodilator inhaled corticosteroid fixed combinations
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.
otherDrug
Also called no inhalation therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: LABA + LAMA | |
| ASTHMA | patients with asthma and a normal spirometry
Clinical intervention: Inhaled corticosteroids (ICS) Receives: Drug: ICS | |
| ASTHMA COPD OVERLAP SYNDROME | patients with an obstructive spirometry and characteristics of both COPD and Asthma
Clinical Intervention: LABA + LAMA + ICS Receives: Drug: LABA + LAMA + ICS | |
| OBSTRUCTIVE ASTHMA | patients with an obstructive spirometry and characteristics of asthma
Clinical Intervention: LABA + ICS inhaled therapy Receives: Drug: LABA + ICS | |
| OTHER | patients with another diagnosis or healthy persons
clinical Intervention: undefined - according to diagnosis Receives: Drug: other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the proposed diagnostic algorithm
% changes of algorithm diagnosis compared to physician based diagnosis (based on spirometry only)
Measured: 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))
Measured: at one year
Secondary outcomes (6)
Difference in ACT/CAT-scores
Difference of ACT/CAT-score between arms at 3 months
Measured: 3 months
Difference in ACT/CAT-scores
Difference of ACT/CAT-scores between arms at 1 year
Measured: 1 year
Difference in Delta ACT/CAT scores (0 - 3 months)
Difference of delta ACT/CAT-scores (0 - 3 months) between arms
Measured: 3 months
Difference in Delta ACT/CAT scores (0 - 1 year)
Difference of delta ACT/CAT-scores (0 - 1 year) between arms
Measured: 1 year
specificity and sensitivity of individual criteria for final diagnosis
ROC curve analysis for individual criteria in predicting final diagnosis
Measured: 1 year
independency of criteria for final diagnosis
Logistic regression analysis for criteria in predicting final diagnosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2020
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wim Janssens, KU Leuven
- Investigators
- Wim Janssens, MD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488590
- Sponsor's protocol ID
- S57767
- Acronym
- ACOS
- Status last verified
- Apr 2020
- First submitted
- 29 Jun 2015
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases
- ClinicalTrials.gov ID
- NCT02488590
- Acronym / sponsor ID
- ACOS / S57767
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2020 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Physician based diagnosis: diagnosis based on clinical exam and spirometry
- Algorithm based diagnosis: diagnosis based on clinical exam and test battery
- Final standard diagnosis diagnosis based on clinical exam, test battery and clinical evolution of 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | – | Drug: LABA + LAMAPatients 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 |
| ASTHMA | – | Drug: ICSpatients with asthma and a normal spirometry Clinical intervention: Inhaled corticosteroids (ICS) |
| ASTHMA COPD OVERLAP SYNDROME | – | Drug: LABA + LAMA + ICSpatients with an obstructive spirometry and characteristics of both COPD and Asthma Clinical Intervention: LABA + LAMA + ICS |
| OBSTRUCTIVE ASTHMA | – | Drug: LABA + ICSpatients with an obstructive spirometry and characteristics of asthma Clinical Intervention: LABA + ICS inhaled therapy |
| OTHER | – | Drug: otherpatients with another diagnosis or healthy persons clinical Intervention: undefined - according to diagnosis |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Subjects with respiratory symptoms suggestive of chronic airway disease
Key exclusion criteria (4 listed)
- 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..).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LABA + LAMAAlso: dual bronchodilationAn 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. | Drug | CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
| ICSAlso: inhaled cortiscosteroidsAn 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. | Drug | ASTHMA |
| LABA + LAMA + ICSAlso: triple therapyAn 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. | Drug | ASTHMA COPD OVERLAP SYNDROME |
| LABA + ICSAlso: bronchodilator inhaled corticosteroid fixed combinationsAn 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. | Drug | OBSTRUCTIVE ASTHMA |
| otherAlso: no inhalation therapyAn 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. | Drug | OTHER |
Primary outcome
Accuracy of the proposed diagnostic algorithm
Time frame: after work-up at inclusion (at baseline)
% changes of algorithm diagnosis compared to physician based diagnosis (based on spirometry only)
Accuracy of the proposed diagnostic algorithm (at one year follow-up)
Time frame: at one year
% changes of algorithm diagnosis compared to final diagnosis (based on all tests with clinical evolution for 1 year))
6 secondary outcomes
Difference in ACT/CAT-scores
Time frame: 3 months
Difference in ACT/CAT-scores
Time frame: 1 year
Difference in Delta ACT/CAT scores (0 - 3 months)
Time frame: 3 months
Difference in Delta ACT/CAT scores (0 - 1 year)
Time frame: 1 year
specificity and sensitivity of individual criteria for final diagnosis
Time frame: 1 year
independency of criteria for final diagnosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Janssens, MD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the proposed diagnostic algorithm (time frame: after work-up at inclusion (at baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.