The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome

NCT03817333 | Completed

• 1 other identifier: CÉR21047
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Asthma; COPD

Keywords

phenotype; inflammation; pulmonary function; comorbidities

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (8)

• Spirometry results

  Baseline

• Sputum eosinophil percentage

  Baseline

• Concentration of Blood biomarkers

  Baseline

• Asthma quality of life questionnaire (AQLQ) score

  Baseline

• Number of patients with comorbidities

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• With an IRAO.

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum and blood

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Louis-Philippe Boulet, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 25, 2019
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

CA (1)