CompletedNCT03817333Updated Jan 25, 2019

The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome

An observational study in Asthma and COPD, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Laval University · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 115
Ages: 45 Years and older
Sex: All

Study 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). 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.

Conditions studied

Asthma
COPD

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Keywords

phenotype
inflammation
pulmonary function
comorbidities

In context

Asthma

4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 115 is below the median of 150 across 993 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Laval University is the lead sponsor of 380 studies on the registry; 70 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Asthmatic subjects will be recruited from the asthma outpatient clinic, from participation to past research studies, or from advertisements.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.
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.

Exclusion criteria

Exclusion Criteria:

ALL SUBJECTS
1. With COPD without a past diagnosis of asthma.
2. Unstable respiratory or non-respiratory condition.
3. Any active chronic inflammatory disease.
4. Any evidence of malignancy (active and/or treated) within the previous 5 years.
5. Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
6. Any history of bronchial thermoplasty. IRAO SUBJECTS

1. Use of any nicotine containing product within 1 year prior to study entry or a smoking history of > 5 pack-years.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 115 participants (actual)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

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 researchers measure

Primary outcomes

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.
Time frame: Baseline

Secondary outcomes

Spirometry results
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC
Time frame: Baseline
Sputum eosinophil percentage
Percentage of sputum eosinophils
Time frame: Baseline
Concentration of Blood biomarkers
alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen
Time frame: 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.
Time frame: Baseline
Number of patients with comorbidities
gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression
Time frame: Baseline
Number of asthma exacerbations in the previous year
emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
Time frame: 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.
Time frame: 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
Time frame: Baseline to one-year follow-up

Study locations

1 site

Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec G1V 4G5, Canada

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2014 to primary completion in Dec 2016, 33 months.

Of 311 non-industry observational studies under Asthma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 100. This study's 33 months is below that.

Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 13, 2016
First posted: Jan 25, 2019
StartActual: Mar 2014
Primary completionActual: Dec 2016
CompletionActual: Dec 2017
Last update: Jan 25, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03817333
Lead sponsor: Laval University
Responsible party: Sponsor
First posted: Jan 25, 2019
Start date: Mar 2014
Primary completion: Dec 2016
Completion: Dec 2017
Last update: Jan 25, 2019

Study contacts

Louis-Philippe Boulet, MD

principal investigator · Laval University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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