AsthmaNCT03817333
The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome
An observational study of Asthma and COPD, run by Laval University at 1 site in Canada.
Trial summary
RATIONALE: In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Read more about this study
- Who is it for?
- Ages 45 years and older
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Dec 2017
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthmatic subjects will be recruited from the asthma outpatient clinic, from participation to past research studies, or from advertisements.
Who may be able to join
- ALL SUBJECTS
- Subjects aged 45 years and older.
- Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
- Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
- Free of respiratory infection in the 4 weeks preceding the study.
- No changes in the asthma and COPD-related medications in the 4 weeks preceding the study.
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- If female, not pregnant (or lactating).
- Able to adhere to study procedures.
- Able and willing to provide written informed consent to participate in the study, in accordance with international conference on harmonization (ICH) good clinical practice (GCP) requirements.
- ACOS SUBJECTS
- 1. Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions section). IRAO SUBJECTS
- Long-life non-smokers or ex-smokers defined as someone who smoked less than 5 pack-years and who completely stopped smoking for at least 12 months before inclusion in the study.
- With an IRAO.
Who cannot join
- ALL SUBJECTS
- With COPD without a past diagnosis of asthma.
- Unstable respiratory or non-respiratory condition.
- Any active chronic inflammatory disease.
- Any evidence of malignancy (active and/or treated) within the previous 5 years.
- Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
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- Any history of bronchial thermoplasty. IRAO SUBJECTS
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- Use of any nicotine containing product within 1 year prior to study entry or a smoking history of > 5 pack-years.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome: A Comparison of Asthma Outcomes in Smoking vs Non-smoking Patients With an Incomplete Reversibility of Airway Obstruction (IRAO)
RATIONALE:
In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data support the concept that ACOS is a clinical entity. However, this should be further studied in order to better target therapy.
Read more
AIM:
The objective of this study is to evaluate the comparative features of ACOS
METHODS:
This will be a descriptive study comparing the features of the ACOS with the features of asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study will be done over 1 or 2 visits (within a week interval), according to subjects' availability. The visit will include completion of different questionnaires (asthma control asthma quality of life, medical history, exacerbations, etc.), a thoracic examination, allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.
- Keywords
- phenotype, inflammation, pulmonary function, comorbidities
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACOS smoking history >20 pack-years | Subjects with asthma-COPD overlap syndrome | |
| IRAO smoking history <5 pack-years | Subjects with an incomplete reversibility of airway obstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total asthma control questionnaire (ACQ) score
Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better.
Measured: Baseline
Secondary outcomes (8)
Spirometry results
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC
Measured: Baseline
Sputum eosinophil percentage
Percentage of sputum eosinophils
Measured: Baseline
Concentration of Blood biomarkers
alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen
Measured: Baseline
Asthma quality of life questionnaire (AQLQ) score
Measurement of asthma quality of life using the Mini asthma quality of life questionnaire. It is a 7-point scale questionnaire (where 1 is greatest impairment and 7 is least impairment) containing 15 uqestions divided into 4 domains : symptoms (5 items), activity limitation (4 items), emotional function (3 items), and exposure to environmental stimuli (3 items). during the last 2 weeks. The overall score is the mean of all the responses. Each domain score is calculated from the mean of the items that relate to it.
Measured: Baseline
Number of patients with comorbidities
gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression
Measured: Baseline
Number of asthma exacerbations in the previous year
emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
Measured: Baseline
Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up
Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better.
Measured: Baseline to one-year follow-up
Change from baseline number of exacerbations at one-year follow-up
emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
Measured: Baseline to one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study startMar 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817333
- Sponsor's protocol ID
- CÉR21047
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2016
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome: A Comparison of Asthma Outcomes in Smoking vs Non-smoking Patients With an Incomplete Reversibility of Airway Obstruction (IRAO)
- ClinicalTrials.gov ID
- NCT03817333
- Acronym / sponsor ID
- CÉR21047
- Keywords
- phenotype, inflammation, pulmonary function, comorbidities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Jan 2019 (actual)
- 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.
RATIONALE:
In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data support the concept that ACOS is a clinical entity. However, this should be further studied in order to better target therapy.
AIM:
The objective of this study is to evaluate the comparative features of ACOS
METHODS:
This will be a descriptive study comparing the features of the ACOS with the features of asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study will be done over 1 or 2 visits (within a week interval), according to subjects' availability. The visit will include completion of different questionnaires (asthma control asthma quality of life, medical history, exacerbations, etc.), a thoracic examination, allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACOS smoking history >20 pack-years | – | –Subjects with asthma-COPD overlap syndrome |
| IRAO smoking history <5 pack-years | – | –Subjects with an incomplete reversibility of airway obstruction |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthmatic subjects will be recruited from the asthma outpatient clinic, from participation to past research studies, or from advertisements.
Key inclusion criteria (13 listed)
- ALL SUBJECTS
- Subjects aged 45 years and older.
- Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
- Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
- Free of respiratory infection in the 4 weeks preceding the study.
Key exclusion criteria (9 listed)
- ALL SUBJECTS
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total asthma control questionnaire (ACQ) score
Time frame: Baseline
Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better.
8 secondary outcomes
Spirometry results
Time frame: Baseline
Sputum eosinophil percentage
Time frame: Baseline
Concentration of Blood biomarkers
Time frame: Baseline
Asthma quality of life questionnaire (AQLQ) score
Time frame: Baseline
Number of patients with comorbidities
Time frame: Baseline
Number of asthma exacerbations in the previous year
Time frame: Baseline
Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up
Time frame: Baseline to one-year follow-up
Change from baseline number of exacerbations at one-year follow-up
Time frame: Baseline to one-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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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.
Louis-Philippe Boulet, MD principal investigator
Laval University
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 Asthma and COPD, run by Laval University at 1 site in Canada.
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 13 inclusion and 9 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: finished, as of the sponsor's last update on 25 Jan 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total asthma control questionnaire (ACQ) score (time frame: Baseline). 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 25 Jan 2019.