Recruiting

Observational Study

Sponsor:

Université de Montréal

Code:

NCT02833727

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smoking

Study Details

Brief summary:

Aim : To compare, among patients with an uncontrolled moderate to severe asthma, the blood eosinophil levels of smokers and non-smokers.

Secondary aims: In uncontrolled moderate to severe asthmatic subjects, to compare between asthmatic smokers and non-smokers: sputum eosinophils counts, fractional exhaled nitric oxide (FeNO), pre and post bronchodilator Forced expiratory volume in one second (FEV1) / Forced vital capacity (FVC), Asthma-related quality of life, asthma exacerbations during the year preceding enrolment in the study, Medical direct and indirect costs related to asthma during the year preceding enrolment in the study, and adherence to asthma treatment during the year preceding enrolment in the study.

Methods: Cross sectional observational study. Never-smoker and smoker asthmatics treated with at least 2 controller medications with a smoking history ≥10 pack/year with a ACQ score ≥ 1.5 points will be identified in the database RESP. Their clinical data will be matched to the Régie de l'assurance médicale du Quebec (RAMQ) and Maintenance et exploitation des données pour l'étude de la clientèle hospitalière (MED-ECHO) administrative databases and reMed (data on medications for patients with private health insurance) in order to access to data on medical services, hospitalisations and medications delivered by pharmacies. T

Conditions

Asthma

Study ID

NCT02833727

Start date

Sep, 2016

Status verified date

May, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

May, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participation to the RESP Database.
  • Never-smoker and smoker asthmatics (smoking history ≥10 pack/year)
  • Treatment with at least 2 controller medications
  • ACQ score ≥ 1.5 points will be identified in the database RESP.

Exclusion Criteria:

  • Chronic obstructive Pulmonary Disease (COPD)

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Asthmatic smokers (AS)

Asthmatics will fulfill the following definition of asthma: reversible airflow obstruction and/or a provocative concentration of methacholine inducing a 20% fall in FEV1 (PC20) < 8 mg/ml with a diagnosis of asthma made by a respirologist.

Smokers or ex smokers will be defined by a smoking history of ≥ 10 pack/year.

Asthmatic non-smokers (ANS)

Asthmatics will fulfill the following definition of asthma: reversible airflow obstruction and/or a PC20 < 8 mg/ml with a diagnosis of asthma made by a respirologist.

Never smokers will have a life-long history without smoking.

Interventions

Smoking

Smoking equal or greater than 10 pack/years; never smokers: lifelong history without smoking.

Primary outcome measure

  • blood eosinophil count [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Simone Chaboillez, RT

514 338 2222s-chaboillez@crhsc.rtss.qc.ca

Catherine Lemiere, MD

514 338 2222catherine.lemiere@umontreal.ca

Locations

Hôpital du Sacré-Coeur de Montréal

Recruiting

Montréal, Quebec, Canada, H4J 1C5

Principal Investigator:

Catherine Lemiere, MD,MSc

More Information

Sponsor

Université de Montréal

Last update posted

May 8, 2018

Last verified

May, 2018

Keywords

  • asthma; smoking; Eosinophils; health care costs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2018-05-08.