Airway Inflammation and Disease Burden in Asthmatic Smokers

NCT02833727 | Unknown

• 1 other identifier: 2017-1359
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

asthma; smoking; Eosinophils; health care costs

Outcome Measures

Primary Outcomes (1)

• blood eosinophil count

  one year

Secondary Outcomes (7)

• Sputum eosinophil count

  One year

• Fractional exhaled nitric oxide (FeNO)

  One year

• FEV1

  One year

• Asthma-related quality of life score

  One year

• Asthma exacerbations

  Two years

Study Arms (2)

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.

Other: Smoking

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.

Other: Smoking

Interventions

Smoking OTHER

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

Asthmatic non-smokers (ANS); Asthmatic smokers (AS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Chronic obstructive Pulmonary Disease (COPD)

Sponsors & Collaborators

• Université de Montréal: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

Related Publications (3)

• Tan NC, Nguyen HV, Lye WK, Sankari U, Nadkarni NV. Trends and predictors of asthma costs: results from a 10-year longitudinal study. Eur Respir J. 2016 Mar;47(3):801-9. doi: 10.1183/13993003.00188-2015. Epub 2015 Dec 2.

  PMID: 26647437 BACKGROUND

• Chaudhuri R, Livingston E, McMahon AD, Thomson L, Borland W, Thomson NC. Cigarette smoking impairs the therapeutic response to oral corticosteroids in chronic asthma. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1308-11. doi: 10.1164/rccm.200304-503OC. Epub 2003 Jul 31.

  PMID: 12893649 BACKGROUND

• Sunyer J, Springer G, Jamieson B, Conover C, Detels R, Rinaldo C, Margolick J, Munoz A. Effects of asthma on cell components in peripheral blood among smokers and non-smokers. Clin Exp Allergy. 2003 Nov;33(11):1500-5. doi: 10.1046/j.1365-2222.2003.01730.x.

  PMID: 14616860 BACKGROUND

MeSH Terms

Conditions

Asthma; Smoking

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Catherine Lemiere, MD

  CIUSS du nord de l'île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Chaboillez, RT

CONTACT

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

Catherine Lemiere, MD

CONTACT

514 338 2222; catherine.lemiere@umontreal.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,MSc

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 14, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)