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Completed

NCT Number: NCT03817333

The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome

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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

  • 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.
  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Spirometry results

    Time frame: Baseline

    Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC

  2. Sputum eosinophil percentage

    Time frame: Baseline

    Percentage of sputum eosinophils

  3. Concentration of Blood biomarkers

    Time frame: Baseline

    alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen

  4. Asthma quality of life questionnaire (AQLQ) score

    Time frame: Baseline

    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.

  5. Number of patients with comorbidities

    Time frame: Baseline

    gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression

  6. Number of asthma exacerbations in the previous year

    Time frame: Baseline

    emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits

  7. Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up

    Time frame: Baseline to 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.

  8. Change from baseline number of exacerbations at one-year follow-up

    Time frame: Baseline to one-year follow-up

    emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 25, 2019
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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